PHT 453 practical notes

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					PHT 453 laboratory                                                   ‫أ. بسمة الدوسري‬


                               PHT 453 practical notes
                                     Lab. #1
Preparations :
   1. chloramphenicol suspension ------------------ 25 ml
   2. paracetamol elixir ------------------------------- 50 ml

                                   SUSPENSIONS
         suspensions : are dispersions of finely divided insoluble material (the
          dispersed phase ) which is randomly distributed into the liquid medium ( the
          continueous phase ) .
         they can be classified into :
               Coarse susp. : when particles size is larger than 1 mM in diameter.
               Colloidal susp. : when particles size is less than 1 mM in diameter.

        Suspensions can be used either internally or externally.
        Oral suspensions are liquids containing one or more active ingredients
         suspended in a suitable vehicle.
        Suspended solids may slowly separate on standing but easily redispersed by
         simple shaking.

                 CHLORAMPHENICOL SUSPENSION U.S.P.

Rx                                                        *F
        Chloramphenicol palmitate                4g              1g
        Glycerin                                 20 g             5 g = 4 ml
        Arabic gum ( acacia )                    10 g            2.5 g
        Favouring agent                          q.s.            q.s.
        Simple syrup                             50 g             12.5 g = 9.6 ml
        Water                 to                 100 ml          25 ml
Fiat : susp.           Mitte: 25 ml
Sig. : 1 tsp q 6 hrs.
N.B. : sp. Gr. Of glycerine = 1.25
        sp. Gr. Of simple syrup =1.3

Calculations :

          F = 25/100 = 0.25
          Volume of glycerin = 5 / 1.25 = 4 ml
          Volume of syrup = 12.5 / 1.3 =9.6 ml
          Amount of vehicle = 25 – (4 + 9.6 ) = 11.4 ml of water

Procedure:
     1. triturate Chloramphenicol palmitate with Glycerin and acacia in a mortar
        to give a smooth pourable paste.
     2. dilute the paste with simple syrup ( 5ml ) , mix.



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PHT 453 laboratory                                                           ‫أ. بسمة الدوسري‬

      3. transfere to a cylinder , then add the rest amount of the syrup and add the
         flavor.
      4. complete to volume with water.
      5. transfere to a clean bottle and fix a white label.

Label :
       White

                                  Shake The Bottle Before Use
                           Chloramphenicol Palmitate Suspension
                           One teaspoonful to be taken every six hours
                           Name:                                Date:


Uses:
   1. Chloramphenicol is a broad spectrum antibiotic which is effective against both
      gram +ve and gram –ve organisms.
   2. palmitate ester is used in the susp. ( NOT succinate ) because :
          a. palmitate is insoluble for oral suspensions.
          b. Succinate is water soluble which form a clear solution , so it can be
              used in injections.
          c. Palmitate aster is more palatable than succinate.
   3. glycerin : a wetting agent.
   4. acacia : a suspending agent.
   5. syrup : a sweetening agent.
   6. water : a vehicle.

Dose :
Chloramphenicol wether administered by mouth or IV it is given for adults as 50 –
100 mg / Kg / day in 4 divided doses( every six hours ), depending on the seriousness
of the infection and sensitivity of bacteria.

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                                            ELIXIRS:
ELIXIRS: are aromatic liquid preparations which form a convwnient mean of
administering potent or nauseous medicaments in a palatable form and in a small
dose- volumes . the solvent frequently contains a high proportion of alcohol and / or
syrup with or without glycerin.

            PARACETAMOL ELIXIR ( Martindale 28 th , p. 33 )
Rx                                                             *F
        paracetamol                          120 mg                     1200mg ( 1.2 g )
        ethanol (90%)                        0.7 ml                     7 ml
        propylene glycol                     0.5 ml                     5 ml
        water                                0.5 ml                     5 ml
        glycerin         to                  5 ml                       50 ml
Fiat : elixir            Mitte: 50 ml
Sig. : 1 tsp qid x 4 / 7 prn.


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PHT 453 laboratory                                                          ‫أ. بسمة الدوسري‬



Calculations :

         F = 50 / 5 = 10
         Vehicle ( glycerin ) = 50 – (7+5+5) = 33 ml

Procedure:
   1. in a small beaker , dissolve paracetamol in ethanol and propylene glycol.
   2. add ½ amount of glycerin. Dissolve well using a glass rod.
   3. transfer to a cylinder
   4. add water , and mix.
   5. complete to volume (50 ml ) with glycerin.
   6. transfer to a clean bottle and fix a white label .

Label :
       White

                                          Paracetamol Elixir
                           One teaspoonful to be taken four times daily
                           For four days when necessary.
                           Name:                               Date:


Dose :
(120 mg / 5 ml)
2.5 – 5 ml ( for child up to 1 year)
5 – 10 ml ( for child 1-4 years).

Uses:
   1. Paracetamol is an analgesic and antipyretic used to relief mild to moderate
      pain.
   2. ethanol : a solvent to dissolve paracetamol.
   3. propylene glycol : a co-solvent.
   4. glycerin: a co-solvent and a sweetening agent.


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                            PHT 453 practical notes
                                  Lab # 2

                              ORAL EMULSIONS
are liquids containing one or more active ingredients , they are stabilized oil- in –
water dispersions , either or both phases of which may contain dissolved solids. Solids
may also be suspended in oral emulsions.

     MINERAL OIL EMULSION (USP 23, P.1029 , Matindale 29 th,
                        p.1322)
Rx                                                  *F
        Mineral oil                 500 ml                  12.5 ml
        Acacia (very fine powder) 125 g                     3.125 g
        Syrup                       100 ml                  2.5 ml
        Vanillin                    40 mg                   1 mg
        Alcohol                     60 ml                   1.5 ml
        Purified water       to     1000 ml                 25 ml
Fiat : oral emulsion         Mitte: 25 ml
Sig. : ½ fz BID x 3/7.

Calculations :
F = 25/1000 = 0.025
Vehicle = 25 – (12.5+1.5+2.5) = 8.5 ml

Procedure :
   1. mix mineral oil with acacia in a dry mortar.
   2. add 6 ml water all at once, and emulsify the mixture ( by strong ,rapid
       trituration using the pestle ) until a smooth, creamy mass which produce a
       clicking sound is obtained ( primary emulsion ).
   3. dissolve vanillin in alcohol , then add to a mixture of syrup and 2 ml of water.
   4. add the mixture in step # 3 to the emulsion formed in step #2. the addition
       should be gradual , in divided portions and trituration is performed after each
       addition.
   5. transfere to a cylinder , and adjust to volume with water. Mix.
   6. transfere to a clean dry bottle and fix a white label.
N.B.,
       vanillin may be replaced by not more than 1 % of any other flavouring
          agents.
       For a 100 ml emulsion, 6ml of sweet orange peel tincture, or 200 mg
          benzoic acid may be used as a preservative in place of alcohol.
Label :
       White
                                       Shake Before Use
                               Liquid Paraffin Oral Emulsion
                       One tablespoonful to be taken two times daily
                       for three days.
                       Name:                                 Date:


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PHT 453 laboratory                                                ‫أ. بسمة الدوسري‬



Uses:
This emulsion is used as laxative. Liquid paraffin acts as a lubricant to keep the stools
soft. It is employed in chronic constipation, especially in presence of hemorrhoids.
The mixture should not be taken within 30 min. of meal times and preferably on an
empty stomach.
Role of each ingredient:
    1. mineral oil : a laxative .
    2. acacia : a natural emulsifying agent.
    3. syrup: a sweetening agent.
    4. vanillin: a sweetening and flavouring agent.
    5. alcohol: to dissolve vanillin, preservative.
Dose:
Up to 45 ml is to be given daily , either in divided doses or at bed time.


       LIQID PARAFFIN ORAL EMULSION ( BP ,1980 ,p.559)
Rx                                                    *F
        Liquid paraffin                         500 ml        12.5 ml
        Vanillin                                500 mg        2.5 mg
        Chloroform                              2.5 ml        0.065 ml
        Benzoic acid solution                   20 ml         0.5 ml
        Methyl cellulose 20                     20 g          0.5 g
        Saccharine sodium                       50 mg         1.25 mg
        Water                 to                1000 ml       25 ml
Fiat : oral emulsion          Mitte: 25 ml
Sig. : ½ fz BID x 3/52.
Calculations :
F = 25/1000 = 0.025
Vehicle = 25 – (12.5+0.065+0.5) =

Procedure :
   1. heat abut 8 ml of water until it boils, then sprinkle methyl cellulose on the
       surface and mix. Allow to stand for 30 min. to hydrate the powder .
   2. add a sufficient water in the form of cold water (ice ) and stir mechanically
       until the mucilage is homogenous.
   3. dissolve vanillin in a mixture of the benzoic acid solution and chloroform (
       because it is more soluble in organic solvents). Add the solution to the
       mucilage and stir for 5 min. the small amount of Saccharine sodium may be
       dissolved in water then added to the mucilage.
   4. to prepare the emulsion, add together equal volumes of liquid paraffin and the
       mucilage with constant stirring. ( or try to use a clean dry bottle and emulsify
       by shaking ).
   5. fix a white label.
Label :
       White
                                      Shake Before Use
                              Liquid Paraffin Oral Emulsion
                      One tablespoonful to be taken two times daily
                      for three weeks.


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PHT 453 laboratory                                                          ‫أ. بسمة الدوسري‬

                           Name:                                        Date:

Uses:
This emulsion is used as laxative. The mixture should not be taken within 30 min. of
meal times and preferably on an empty stomach.
   1. liquid paraffin : a laxative .
   2. vanillin: flavoring and sweetening agent.
   3. chloroform: a preservative and a flavoring agent.
   4. benzoic acid solution: a preservative.
   5. methyl cellulose : an emulgent.
   6. saccharine :a sweetening agent.

Storage :
Store in a cool place but do not allow to freeze.


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                                         LINIMENTS
      Liniments are liquid or semi-liquid preparations which are intended for
       external application .
      They may contain substances possessing analgesic, soothing or stimulating
       properties.
      They should be applied to the intact skin and labeled with „ For External Use
       Only‟.

         METHYL SALICYLATE LINIMENT ( BP 1980, P.681)
Rx                                                             *F
        Methyl salicylate             25 ml                             6.25 ml
        Arachis oil             to    100 ml                            25 ml
Fiat :liniment          Mitte: 25 ml
Sig. : apply to the affected skin BID x 2/52.

Calculations :
F = 25/100 = 0.25
Vehicle (arachis oil) = 25 – 6.25 = 18.75 ml
Procedure :
    1. in a mortar, mix methyl salicylate with ½ amount of arachis oil . mix well
       using the pestle.
    2. transfer to a cylinder, and complete to volume with the oil.
    3. transfer to a clean bottle, fix a red label.
Label :
       Red                                Shake Before Use
                                  Methyl Salicylate Liniment
                           Apply to the affected skin two times daily for
                           two weeks.
                           Name:                                Date:



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PHT 453 laboratory                                                           ‫أ. بسمة الدوسري‬



Uses:
Methyl salicylate is absorbed through the skin and is applied in liniments or ointments
to relief pain in rheumatic conditions.

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                                          LINCTUSES
      Linctuses are viscous liquid preparations having demulcent, expectorant or
       sedative properties.
      They are given in doses of small volume to be swallowed slowly without the
       addition of water.
      They are usually used for the relief of cough.

             SIMPLE LINCTUS ( Martindalle 29 & 28 ,p. 1276)

Rx                                                            *F
        Citric acid monohydrate                        125 mg           1.25 g
        Conc. Anise water                              0.05 ml          0.5 ml
        Amaranth solution                              0.1 ml           1 ml
        Syrup                 to                       5 ml             50 ml
Fiat :linctus          Mitte: 50 ml
Sig. : 1 fz swallowed slowly undiluted TID..

Calculations :
F = 50/5 = 10
Vehicle (syrup) = 50 –( 1+0.5 ) = 48.5 ml
Procedure :
    1. dissolve citric acid in about 20 ml of the syrup.
    2. add the conc. Anise water & amaranth sol.
    3. transfer to a cylinder, and complete to volume with the syrup.
    4. transfer to a clean bottle, fix a white label.

Label :
       White                      Simple Linctus
                           One teaspoonful to be swallowed slowly
                           undiluted three times daily.
                           Name:                              Date:

Uses:
Demulcent.

Role of each ingredient:
    1. conc. Anise water: flavouring agent.
    2. amaranth sol. : coloring agent.
    3. syrup: a vehicle & sweetening agent.
Dose:
5 – 10 ml .




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PHT 453 laboratory                                                           ‫أ. بسمة الدوسري‬



simple linctus ( BP 1980, p.680):
Rx
         Citric acid monohydrate                       25 g
         Conc. Anise water                             10 ml
         Amaranth solution                             15 ml
         Chloroform spirit                             60 ml
         Syrup                to                       1000 ml

N.B. the BP formula is the same as martindale formula except for the presence of
Chloroform spirit ( as a preservative & flavouring agent) in the BP prescription.




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PHT 453 laboratory                                               ‫أ. بسمة الدوسري‬



                             PHT 453 practical notes
                                   Lab # 3

                                     LOTIONS:
        Lotions are liquid preparations intended for application to the skin.
        They may contain aqueous alcoholic or emulsified vehicles.
        They are applied without friction.
        They should be generally dispensed in coloured bottles , and the container
         labeled with „ For External Use Only‟.

PHENOLATED CALAMINE LOTION (BP,1988,P.702 + Marindale
                  28 th, p.491)

Rx                                    *F
        Calamine              150 g             15 g
        Zinc oxide            50 g              5g
        Bentonite             30 g              3g
        Sodium citrate        5g                0.5 g
        Liquefied phenol      5 ml              0.5 ml
        Glycerol              50 ml             5 ml
        Purified water to     1000 ml           100 ml
Fiat : lotion.         Mitte: 100 ml
Sig. : MDU.
Calculations :
F = 100/1000 = 0.1
Vehicle = 100 – (5+0.5) = 94.5 ml

Procedure :
   1. dissolve sodium citrate in about ½ amount of water.
   2. triturate calamine , zinc oxide and bentonite with the solution of sodium
      citrate.
   3. add liq. Phenol and glycerol.
   4. transfer to a cylinder and adjust to 100 ml with water.
   5. transfer to a clean bottle and fix a red label.

Label :
       Red
                             Shake Well Before Use
                             Phenolated Calamine Lotion
                             To be used as directed.
                       Name:                       Date:

Uses:
Calamine is mainly used as mild astringent, and protective and sooyhing for sunburns.
Dose:
It is applied topical to the skin , in various concentrations as a lotion or ointment.
Role of each ingredient :
     1. zinc oxide: astringent.


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PHT 453 laboratory                                                          ‫أ. بسمة الدوسري‬

     2.    bentonite: dispersing agent.
     3.    sodium citrate : anti-clotting agent.
     4.    liq. Phenol: disinfectant.
     5.    glycerol: humectant.

N.B. :
           Calamine (BP) is a basic zinc carbonate with a small proportion of ferric
            oxide which give the pink or reddish – brown colour , while
           Calamine (USP) is zinc oxide with small proportions of ferric oxide.


                             CALAMINE LOTION (USP )
Rx
           Calamine                                    80 g
           Zinc oxide                                  80 g
           Glycerin                                    20 ml
           Bentonite magma                             250 ml
           Calcium hydroxide solution to               1000 ml

Procedure:
   1. in a beaker, dilute bentonite magma with an equal volume of calcium
      hydroxide sol.
   2. in a mortar, mix calamine ,ZnO with glycerin. Then add a portion of the
      diluted magma triturating well until a smooth, uniform paste is formed.
   3. incorporate the remainder of the diluted magma gradually.
   4. transfere to a cylinder and complete to volume with calcium hydroxide sol.
   5. transfere to a clean bottle. Fix a red label

                 PHENOLATED CALAMINE LOTION (USP )
Rx
           Liquefied phenol         10 ml
           Calamine lotion          990 ml

Procedure:
    Mix liq. Phenol with calamine lotion.
    Shake thoroughly before dispensing.

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PHT 453 laboratory                                                           ‫أ. بسمة الدوسري‬



                        IODINE OINTMENT (BPC, 1949)
Rx                                                     *F
        Iodine                               4g                1g
        Potassium iodide                     4g                1g
        Water                                4 ml              1 ml
        Yellow simple ointment               88 g              22 g
Fiat : ung.           Mitte: 25 g
Sig. : Ut.Dict.
Calculations :
F =25/100 = 0.25

    PREPARATION OF YELLOW SIMPLE OINTMENT (BP 1980, P.701)
Rx                                *F
       Wool fat             50 g     1.1 g
       Hard paraffin        50 g     1.1 g
       Cetostearyl alcohol 50 g      1.1 g
       Yellow soft paraffin 850 g    18.7 g
Prepare 22 g.
Calculations :
F =22/1000 = 0.022

Procedure :
   1. in a porcelin dish, melt cetostearyl alcohol, hars paraffin, wool fat and yellow
      soft paraffin over a water bath.
   2. when completely melted, discontinue heating and stir until the mixture begins
      to congeal.
   3. powder iodine crystals in a glass mortar ( not too much) .
   4. dissolve KI in water , then add iodine and dissolve.
   5. incorporate the solution of iodine (in # 4 ) gradually into the ointment base
      prepared in step # 2.
   6. transfer to a clean container and fix a red label .

Label :
       Red
                                 Iodine Ointment
                                 To be used as directed.
                           Name:                       Date:

Uses:
    Iodine is a local antibacterial used for disinfecting the unbroken skin before
      operations.
    Iodine is also effective against fungi & protozoa.

Role of each ingredient :
   1. iodine : the active ingredient.
   2. KI : aid in dissolving of iodine.

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PHT 453 laboratory                                                           ‫أ. بسمة الدوسري‬




                     SULFUR OINTMENT ( BP 1980, p.701)
Rx                                                     *F
        Precipitated sulfur   100 g                            3g
        Simple ointment       900 g                            27 g
Fiat :Ung.             Mitte: 30 g
Sig. : Ut.Dict
Calculations :
F =30/1000 = 0.03


                   PREPARATION OF SIMPLE OINTMENT:
Rx                               *F
       Wool fat            50 g     1.35 g
       Hard paraffin       50 g     1.35 g
       Cetostearyl alcohol 50 g     1.35 g
       White soft paraffin 850 g    22.95 g
Prepare 27 g.
Calculations :
F =27/1000 = 0.027

Procedure :
1. in a porcelin dish, melt cetostearyl alcohol, hard paraffin, wool fat and soft
   paraffin over a water bath .
2. remove from the heat and stir until cold.
3. powder ppt. Sulfur in a mortar , then incorporate with a portion of the simple
   ointment until smooth.
4. gradually add the remainder of simple ointment and mix thoroughly.
5. transfer to a clean container and fix a red label.

Label :
       Red
                                 Sulfur Ointment 10%
                                 To be used as directed.
                           Name:                       Date:
Uses:
Sulfur is a keratolytic and a mild antiseptic. It is widely employed in the form of
lotions or ointments, in the treatment of acne, dandruff, seborrhoeic conditions and
scabies.


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PHT 453 laboratory                                             ‫أ. بسمة الدوسري‬




                              PHT 453 practical notes
                                    Lab # 4

                                     CREAMS
      Creams are semi-solid emulsions, which are intended for application to the
       skin. They usually consist of solutions or dispersions of one or more active
       ingredients in a suitable base.
      They may be water – miscible (o/w emulsions) described as aqueous creams
       or oil – miscible (w/o emulsions) described as oily creams.
      Creams should be kept and stored in well closed containers which prevent
       evaporation and kept below 25 oC.
      They should be labeled with “ For External Use Only”.

 ZINC AND ICHTHAMMOL CREAM (BP 1980,p.548 + Matindale
                   29th,p.936)

Rx                                    *F
        Ichthammol             50 g               1g
        Cetostearyl alcohol    30 g               0.6 g
        Wool fat               100 g              2g
        Zinc cream to          1000g              20 g
Fiat : oily cream.             Mitte: 20 g
Sig. : Ut.Dict.

Calculations :
F =20/1000 = 0.02
Vehicle (zinc cream) = 20-(2+0.6+1) = 16.4 g
Procedure :
   1. in a porcelin dish, melt wool fat and cetostearyl alc. (use cetyl alc. Instead)
       over a water bath.
   2. when completely melted, triturate and mix with the calculated amount of zinc
       cream.
   3. incorporate ichthammol ,stir well.
   4. transfere to a clean container and fix a red label .

Label :
       Red
                             Zinc and Ichthammol Cream
                             To be used as directed.
                       Name:                       Date:

Uses:
    ichthammol is a local antibacterial used for treatment of skin disorders such as
      psoriasis, and promote healing of chronic inflammation.

Dose :
Topical to the skin as 5-10 % ointment or cream.


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PHT 453 laboratory                                                           ‫أ. بسمة الدوسري‬




Storage:
In cool place and well-closed containers which prevents evaporation and
contamination.

Role of each ingredient :
   1. ichthammol: a slight bacteriostatic for treating of dermatitis and eczema.
   2. zinc cream: mild astringent and protective . it is also widely employed in other
       official creams.

                            ZINC CREAM (BP 1980,p.548)

Rx                                                     *F
       Zinc oxide , finely sifted            320 g             8g
       Calcium hydroxide                     0.45 g            0.01 g
       Oleic acid                            5 ml              0.125 ml
       Arachis oil                           320 ml            8 ml
       Wool fat                              80 g              2g
       Purified water          to            1000 g            25 g
Fiat : cream.          Mitte: 25 g

Calculations :
F =25/1000 = 0.025
Vehicle (water) = 25-(0.125+8) = 16.875 ml
Procedure :
   1. mix zinc oxide and calcium hydroxide.
   2. triturate to a smooth paste with a mixture of oleic acid and arachis oil.
   3. incorporate the wool fat. Stir well.
   4. add gradually with stirring the calculated amount of water to make 25 g.
   5. weigh the required amount (16.4 g) of the resulted zinc cream and use in the
       above prescription.
Role of each ingredient :
   1. zinc oxide : is applied externally as a mild astringent for the skin, and as a
       soothing and protective application in eczema .
   2. arachis oil : emollient and soothing to inflamed surface , to soften skin in
       eczema and psoriasis.


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PHT 453 laboratory                                                          ‫أ. بسمة الدوسري‬




                                         OINTMENTS
        Ointments are semi-solid preparations consisting of a medicament or mixture
         of medicaments dissolved or dispersed in a suitable base.
        They are used as emollients or protective preparations on the skin.
        They are water-immiscible .
        Emulsifiable bases make the ointment miscible with tissue exudates and are
         more readily removable from the skin by washing.


     CETRIMIDE EMULSIFYING OINTMENT ( BP 1980,p.697 +
                  Martindale 29th,p.954)
Rx                                           *F
        Cetrimide             30 g                     0.75 g
        Cetostearyl alcohol 270 g                      6.75 g
        Liquid paraffin       200 g                    5g
        White soft paraffin 500 g                      12.5 g
Fiat : oint.           Mitte: 25 g
Sig. : MDU.

Calculations :
F =25/1000 = 0.025
Procedure :
   1. in a porcelin dish, melt cetostearyl alc. (use cetyl alc. Instead) over a water
       bath. Then add white soft paraffin to melt. Finally, add liquid paraffin.
   2. when completely melted, add cetrimide and stir well.
   3. remove from water bath and stir until cold.
   4. transfer to a clean container and fix a red label .

Label :
       Red
                                 Cetrimide Emulsifying Ointment
                                 To be used as directed.
                           Name:                       Date:

Uses:
Cetrimide is a quaternary ammonium ( cetyltrimethylammonium bromide)
disinfectant. It is employed for cleansing the skin , wounds, and burns because of its
bactericidal activity. It is mainly used as a cream containing 0.5% concentration.

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PHT 453 laboratory                                                        ‫أ. بسمة الدوسري‬


                                PHT 453 practical notes
                                      Lab # 5

                                    EYE OINTMENT
      These are prepared using aseptic techniques under conditions appropriate for
       the preparation of sterile products.
      The medicament is finely powdered , thoroughly levigated with small quantity
       of the sterile melted base, and then incorporated with the remainder of the
       base.
      The finished product is packed into sterile small collapsible tubes which must
       be free from dirt and metallic particles.

     ATROPINE SULFATE EYE OINTMENT 1% (BP 1980,p.690)
Rx                                           *F
         Atropine sulfate           1g                0.2 g
         Liquid paraffin            10 g              2g
         Wool fat                   10 g              2g
         Yellow soft paraffin 80 g                    16 g
Fiat : ung.                Mitte: 20 g
Sig. : Ut.Dict
Calculations :
F =20/100 = 0.2
Procedure :
     1. in a porcelin dish, melt yellow soft paraffin over a water bath. Then add wool
         fat to melt. Stir until liquefied. Finally, add liquid paraffin.
     2. when completely melted, discontinue heating , stir until cold.
     3. add atropine sulfate and stir the mixture until it begins to congeal.
     4. pack into a suitable container and fix a red label .
Label :
         Red
                                    Atropine Sulfate Eye Ointment
                                    To be used as directed.
                           Name:                               Date:
Uses:
Atropine sulfate is used to:
     1. dilate (enlarge) the pupil before eye examination. Dilatation of the pupil
         occurs in ½ to 1 hour following one local application and last for a week or
         more.
     2. treatment of closed-angle glaucoma.
Role of each ingredient:
     1. liquid paraffin : used externally as an ophthalmic lubricant.
     2. yellow soft paraffin: is used in eye ointments because the bleached white soft
         paraffin is irritant to the eye.
Dose:
It is applied topically into the conjunctival sac as 0.5-2% ointment , once for
ophthalmic testing and 3 – 4 times a day for treating acute inflammation.
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PHT 453 laboratory                                                ‫أ. بسمة الدوسري‬


                                    EYE DROPS
      Eye drops are aqueous or oily solutions or suspensions for instillation into the
       eye .
      They should be sterile and prepared under conditions appropriate for the
       preparation of sterile products (aseptic conditions). The method of sterilization
       is stated in each monograph.
      For aqueous solutions, water for injection should be used.
      Eye drops should be prepared in a vehicle which is bactericidal and fungicidal.
      They should be isotonic with lachrymal secretions (which is equivalent to
       0.9% NS).
      Dropper plastic bottles are suitable for packing eye drops.
      Label should instruct the patint to discard the unused eye drops no longer than
       one month after opening the container.

  BENZALKONIUM CHLORIDE SOLUTION (Martindale 28th &
                           29th ,p.952)
      ( Hard contact lens solution ) or ( EDTA eye drops )
Rx                                                           *F
        benzalkonium chloride solution          0.02 ml              0.004 ml
        disodium edetate                        50 mg                10 mg
        sodium chloride                         900 mg               180 mg
        water for injection    to               100 ml                20 ml
Fiat :sol.              Mitte: 20 ml
Sig. : Ut.Dict

Calculations :
F =20/100 = 0.2
Procedure :
   1. mix benzalkonium chloride solution , disodium edetate and sodium chloride in
        about 2/3 the amount of vehicle (water for injection).
   2. transfere to a cylinder and complete to volume with WFI.
   3. transfere into a suitable container and fix a red label .
Label :
        Red
                                benzalkonium Chloride Solution
                                To be used as directed.
                        Name:                          Date:
Uses:
Antiseptic with bactericidal and bacteriostatic activities.
Role of each ingredient:
   1. benzalkonium Chloride : active ingredient, preservative for some eye drops in
        0.015 solutions, and antiseptic.
   2. disodium edentate: inactivation of bacterial collagenase so it enhances the
        bactericidal activity of benzalkonium Chloride.
   3. sodium chloride : to adjust isotonicity.
   4. water: vehicle.
Notes :
   1. sterilized by autoclaving ( because it is an eye drop preparation).


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     2.   store in airtight containers, protect from light.
     3.   it is incompatible with eye drops containing local anaesthetics.
     4.   incompatible with some rubber containers (produce deposits).
     5.   loss of activity when in contact with plastic materials ,e.g., polyvinyl chloride.
     6.   loss of activity in presence of cotton.

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  CHLORAMPHENICOL EYE DROPS (Martindale 28th & 29th ,p.
                      192)
Rx                                                                      *F
        Chloramphenicol                                0.5 g                     0.1 g
        Boric acid                                     1.5 g                     0.3 g
        Borax                                          0.3 g                     0.06 g
        Phenylmercuric nitrate                         0.002 g                   0.0004 g
        Water for injection          to                100 ml                    20 ml
Fiat :eye drops.              Mitte: 20 ml
Sig. : Ut.Dict

Calculations :
F =20/100 = 0.2
Procedure :
    1. dissolve Chloramphenicol, Boric acid, Borax, and Phenylmercuric nitrate in
        about 2/3 the amount of vehicle.
    2. transfere to a cylinder and complete to volume with WFI.
    3. transfere into a suitable container and fix a red label .
Label :
        Red
                               Chloramphenicol Eye Drops
                               To be used as directed.
                        Name:                          Date:
Uses:
Wide spectrum antibiotic used for the treatment of acute bacterial infection of the
external eye.
Role of each ingredient:
    1. Boric acid and borax : to adjust the isotonicity.
    2. Phenylmercuric nitrate: preservative.
    3. water: vehicle.
Notes :
    1. sterilize by heating at 98 o to 100 oC for 30 min.
    2. store in airtight containers, below 25 oC and used within three months. Storage
        at 2-8 oC prolong the shelf life to 12 months.
    3. it should be protected from light.

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PHT 453 laboratory                                                ‫أ. بسمة الدوسري‬


                             PHT 453 practical notes
                                   Lab # 6

                                      PASTES
      Pastes are solid preparations intended for external application .
      They usually contain a high proportion of medicaments which are not intended
       to be absorbed.
      ZINC GELATIN U.S.P. (USP+ Martindale 28th & 29th,p.936)
                     “ UNNA,S PASTE “
Rx                                              *F
        Zinc oxide, finely sifted      10 g             5g
        Gelatin sheets                 15 g             7.5 g
        Glycerin                       40 g             20 g
        Water                          35 g             17.5 g
            ,
Fiat : Unna s paste .           Mitte: 50 g
Sig. : Ut.Dict
N.B. sp.gr. of glycerin = 1.3
Calculations :
F =50/100 = 0.5
Volume of glycerin = 20/1.3 = 15.4 ml.
Procedure :
    1. cut gelatin sheets into small pieces , after getting rid of the rigid edges.
    2. weigh the amount of gelatin required and soak in water. Allow to stand for 15
        min.
    3. add ½ amount of glycerin to the soaked gelatin in a porcelin dish, and place
        the dish on water bath until all gelatin is well dissolved.
    4. levigate zinc oxide in the remaining amount of glycerin, then add to the gelatin
        solution.
    5. stir gently with a glass rod in cross-lines ( to avoid air entrapment) until a
        smooth gelly results and a drop of the solution becomes a line or a thread.
    6. pour the paste while hot on a glass slide and allow to set and cool .
    7. cut the paste into small pieces and pack in a suitable container. Fix a red label.

Label :
       Red
                             Zinc Gelatin USP
                             To be used as directed.
                       Name:                       Date:
Uses:
Zinc gelatin is used as a protective and supportive dressing for varicose ulcers.
Role of each ingredient:
Zinc oxide : a mild astringent and absorptive.
Advice to patient when dispensed:
   1. clean the leg or foot thoroughly.
   2. apply a dusting powder ,e.g., talc powder.
   3. the paste is previously melted and warmed.
   4. apply the paste with a brush to the affected part.
   5. cover the paste with a gauze bandage.


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PHT 453 laboratory                                                          ‫أ. بسمة الدوسري‬

     6. apply another layer of the paste (until the third layer of bandage).
     7. leave the dressing for three days to two weeks.
     8. remove by soaking in warm water.
Dose:
It is applied externally , as an occlusive bandage „ dressing ‟.
Container:
the preparation is divided into small pieces before packing in a jar so that the patient
can melt an appropriate number for each treatment.
Storage:
Store in a cool place.
Notes:
     1. the paste should be free from air bubbles.
     2. the paste should be smooth „ free from gritty particles of zinc oxide and
         particles of gelatin „.

FORMULA OF THE BRITISH PHARMACOPEIA:
                                  ZINC GELATIN (BP)
                                   “ UNNA,S PASTE “
Rx                                                       *F
         Zinc oxide, finely sifted           15 g              7.5 g
         Gelatin sheets                      15 g              7.5 g
         Glycerin                            35 g              17.5 g
         Water                               35 g              17.5 g

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COMPOUND BENZOIC ACID OINTMENT ( Whitfield,s ointment)
                 (BP 1980 ,p.697)

Rx                                                       *F
        Salicylic acid (fine powder) 30 g                      0.75 g
        Benzoic acid (fine powder) 60 g                        1.5 g
        Emulsifying ointment         910 g                     22.75 g
Fiat :Ung.              Mitte: 25 g
Sig. : Ut.Dict
Calculations :
F =25/1000 = 0.025

               PREPARATION OF EMULSIFUING OINTMENT:
Rx                               *F
       Emulsifying wax     300 g    6.825 g
       White soft paraffin 500 g    11.375 g
       Liquid paraffin     200 g    4.55 g
Prepare 22.75 g.
Calculations :
F =22.75/1000 = 0.02275


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PHT 453 laboratory                                                           ‫أ. بسمة الدوسري‬


                  PREPARATION OF EMULSIFUING WAX:
Rx                               *F
        Cetostearyl alcohol 90 g    6.12 g
       Sod. Lauryl sulfate 10 g     0.68 g
       Water                4 ml    0.272 ml
Prepare 6.83 g.
Calculations :
F =6.83/100 = 0.068

Procedure :
1. in a porcelin dish, melt cetostearyl alcohol over a water bath ,then add sod. Lauryl
   sulfate and mix . add water , heat and stir vigoursly until frothing ceases.
   ( emulsifying wax).
2. to the emulsifying wax (in step # 1), add white soft paraffin , and stir well to mix .
   then add liquid paraffin and mix until cold ( emulsifying ointment).
3. in a mortar, triturate salicylic acid and benzoic acid into fine powders.
4. gradually add a smaller portion of the melted emulsifying ointment , stir until
   smooth.
5. add the remainder of emulsifying ointment and mix thoroughly.
6. transfer to a clean container and fix a red label.

Label :
       Red
                           Compound Benzoic Acid Ointment
                                 To be used as directed.
                           Name:                       Date:
Uses:
    Benzoic acid: is an antibacterial and antifungal agent.
    Salicylic acid ; is a keratolytic agent.

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PHT 453 laboratory                                                ‫أ. بسمة الدوسري‬


                              LYSOL SOLUTION

    Lysol solution consists of a mixture of cresol and soap solution .
    It is used as : general disinfectant for hospital use , and as antiseptic solution in
     vaginal douches in a conc. Of 1:500.
    Formulation:
         Lysol solution consist of cresol, soap solution in addition to electrolytes (
            e.g., sod chloride, sod. Benzoate, sod. Salicylate) and non-electrolytes
            (e.g., alcohol, glycerol).
         Cresol is a substance with a characteristic odour resembling phenol, but
            more tarry. (caustic substance).
         Soap; is prepared by interaction of fixed oil (castor oil or olive oil) and
            fatty acids (oleic acid) with the aid of KOH or NaOH together with
            water.




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PHT 453 laboratory                                                ‫أ. بسمة الدوسري‬


       PARENTRAL ADMIXTURES AND INCOMPATIBILITIES
IV Admixtures:
        The combination of parenteral dosage forms for administration as single entity
is called an „ admixture‟ .
Reasons for Rx admixture:
Several drugs are combined and administered together for:
    1. The convenience and time saving.
    2. Reduction of number of injections.
    3. Provide treatment for several conditions simultaneously.
    4. Provide ability to give drugs in controlled increments.

Parenteral Incompatibilities:
         When one or more additives are combined with an IV fluid, their presence
together may modify the inherent characteristics of the drug substances present.
         In other words, these incompatibilities take place when drugs are mixed with
others to produce a product unsuitable for administration to the patient.
i.e., patient may receive subtherapeutic or toxic levels of a drug, and if precipitation
occur, it will cause irritation to the vein and occlusion of vessels.

Incompatibilities can be classified into three categories:
   1. Therapeutic incompatibilities: occur when two or more drugs are
   administered concurrently resulting in undesirable antagonistic (under dose) or
   synergistic (over dose) pharmacological action. Adverse drug reactions may be
   considered as therapeutic incompatibilities.
       This type of incompatibility is difficult to detect by clinical studies (in vitro &
   in vivo).
   Examples of antagonistic effects:
        Chloramphenicol and penicillin:
        Penicillin antagonizes the effect of heparin and produces a misleading
           picture of anticoagulant effect of heparin.
        Gentamicin and penicillin: ------- in vitro inactivation of each other.
   Examples of synergistic effects:
        Folic acid and methotrexate.
        Calcium ion and digoxin.

   2. Physical incompatibilities: occur when the combination of two or more drugs
   results in a change in the appearance of the solution, such as a change in the color
   , formation of turbidity or precipitate, or the evolution of a gas .
        This type of incompatibilities is easily detected by visual detection.
   Examples:
         Salts of weak acid Phenobarbital precipitate as free acids in IV solutions
           having an acidic pH.
         Cephalothin + gentamicin ------- yellow ppt.
         Valium (Diazepam), which require a special diluent for solubilization, will
           precipitate when added to an aqueous solution due to low water solubility.




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PHT 453 laboratory                                                ‫أ. بسمة الدوسري‬

   3. Chemical incompatibilities: occur when the combination of two or more
       drug solutions results in degradation of drugs due to hydrolysis, oxidation,
       reduction, or complexing.
       This type of incompatibilities is difficult to detect and need suitable analytical
       methods.
Examples:
          Tetracycline + calcium ------ complex (inactive form).
          Ampicillin + D5W ----------- hydrolysis.
Therefore:
1.     Ampicillin should be diluted with normal saline (NS).
          This sol. Is most stable at pH 7.5, (chemical degradation increases with
             increasing or decreasing pH.
          Ampicillin solution is stable:
                for 8 hr at room temperature,
                for 48 hr under refrigeration when reconstituted with WFI,
                for 72 hr under refrigeration when reconstituted with NS.
          Dextrose solution should be avoided.

2.      for Bactrim ( trimethoprim + sulfamethoxazole ):
           Dextrose is preferred if a dilution of 1:10 ( v/v ) is desirable.
           D5W or NS is preferred if a dilution of 1:25 ( v/v ) is desirable.

An important factor in causing parenteral incompatibilities is a change in the
acid-base environment. The solubility and stability of the drug may vary as the pH of
the solution changes.
   The effect of pH on the stability is illustrated in case of penicillin. The antibiotic
      remains active for 24 hr at pH 6.5, but at pH 3.5 it is destroyed in a short time.
   Potassium penicillin G contains a citrate buffer and is buffered at pH 6.0 to 6.5
      when reconstituted with sterile WFI, dextrose injection, or sodium chloride
      injection. When this reconstituted solution is added to IV fluid such as dextrose
      injection or sodium chloride injection, the normal acid pH of the solution is
      buffered at pH 6.0 to 6.5, thus assuring the activity of the antibiotic.

Minimization of incompatibilities:
     1. Proper selection of diluents ( either WFI, NS, D5W, LR(lactated Ringer‟s) )
     2. Drug concentration: dilution may prevent incompatibility, e.g., erythromycin
        lactobionate is incompatible with electrolytes in concentrated form. However,
        it is compatible when properly diluted.
            Erythromycin + small volume 0.9% NaCl ------ solid gel.
            Erythromycin + 1 L bottle of 0.9% NaCl -------- will dissolve
               completely.
     3. Increase knowledge of parenteral admixtures and incompatibilities : this is
        could be made by :
            Continuous education, especially for IV staff,.
            Make physician aware of possible incompatibility and always be ready
               to suggest alternative approaches (either selecting another rout of
               administration, site of administration, or change the drug involved).
            Learning to utilize available sources of information , either:
                     Computer system, during entering drug to the patient profile.


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PHT 453 laboratory                                             ‫أ. بسمة الدوسري‬

                    Using Micromedex for complete drug monograph.
                    Using available books, e.g., handbook on injectable drugs.
                    Using the paflet of the drug provided by the company.
                    Using available chart alert.
   4.   Modify the order of mixing.
   5.   Appropriate storage conditions (at room temp., refrigerated, frozen).
   6.   Selection of proper container (glass or plastic). For example, diazepam loses
        38% of its activity after two hours storage in plastic packages.
   7.   Periodical observation of running tubes.

Tutorial on Handbook of Injectable Drugs:
Each drug monograph contains 5 tables:
   1. Table 1: solution compatibility for IV administration.
   2. Table 2: reconstitution solution for drugs.
   3. Table 3: additive compatibility.
   4. Table 4: drug in syringe compatibility.
   5. Table 5: y-site injection compatibility.

Using the Handbook of Injectable Drugs, check the stability of :
   1. Ampicillin in D5W.
   2. Ampicillin in NS.
   3. Hydralazine in LR.
   4. Gentamicin in NS.
   5. Penicillin G in NS.
   6. Clidamycin with penicillins.
   7. Insulin with TPN # 9.
   8. Morphine and Phenobarbital.

Using the drug interaction alert, discuss the drug interaction of the following:
   1. Triamterene + enalapril.
   2. Lanoxin + inderal.
   3. Tyramine + MAO inhibitors.
   4. Cold remedies + MAO inhibitors.
   5. Aspirin + insulin.
   6. Vaccines + corticosteroids.
   7. Aspirin + ciprofloxacin.
   8. Insulin + thyroid hormone.
   9. Ciprofloxacin + digoxin.
   10. Theophyllin + propranolol.
   11. Imipramine + carbamazepine.
   12. Aspirin + probencid.


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PHT 453 laboratory                          ‫أ. بسمة الدوسري‬


   13. Indomethacin + frusemide.
   14. Verapamil + diazepam.
   15. Frusemide + methyl dopa.
   16. Gentamicin + ethacrynic acid.
   17. Guanethidine + tolbutamide.
   18. Amoxycillin + probencid.
   19. Aspirin + warfarin.




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PHT 453 laboratory                                            ‫أ. بسمة الدوسري‬



Using the Handbook of Injectable Drugs, check the stability of:
   1. Ampicillin in D5W.
   2. Ampicillin in NS.
   3. Hydralazine in LR.
   4. Gentamicin in NS.
   5. Penicillin G in NS.
   6. Clidamycin with penicillins.
   7. Insulin with TPN # 9.
   8. Morphine and Phenobarbital.
Using the drug interaction alert, discuss the drug interaction of the following:
   1. Triamterene + enalapril.
   2. Lanoxin + inderal.
   3. Tyramine + MAO inhibitors.
   4. Cold remedies + MAO inhibitors.
   5. Aspirin + insulin.
   6. Vaccines + corticosteroids.
   7. Aspirin + ciprofloxacin.
   8. Insulin + thyroid hormone.
   9. Ciprofloxacin + digoxin.
   10. Theophyllin + propranolol.
   11. Imipramine + carbamazepine.
   12. Aspirin + probencid.
   13. Indomethacin + frusemide.
   14. Verapamil + diazepam.
   15. Frusemide + methyl dopa.
   16. Gentamicin + ethacrynic acid.
   17. Guanethidine + tolbutamide.
   18. Amoxycillin + probencid.
   19. Aspirin + warfarin.




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