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Changing Face of Homoeopathic Pharmacy

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					Changing Face of
Homoeopathic Pharmacy


   Lecture by Dr. P. N. Varma
Changing face of Homoeopathic
Pharmacy

   The basis of homoeopathic medicine is
    Experimental Pharmacology (Proving as
    known in homoeopathy).

   This essentially calls for that the raw
    material should be one used in the
    proving
Standards are fixed to ensure that
the aim of original drug is achieved

It takes into consideration.
a)   Organon aphorisms 264 to 287
b)   The availability of situation
c)   Pharmaceutical aspects of preparation
     without losing the original medicinal
     power
Organon aphorisms 264 – 287
further elaborate the aim
Genuineness, authenticity and standard quality        § 264 –
(unimpaired strength)                                 265

The product should be in natural & crude state        § 266

Prepared as per methods of… (homoeopathic             § 267
pharmacopoeial technique)
Used in dose sufficient to initiate the drug action   § 283

Material quantity MT and minor variation is of no     § 284
significance (provided not used for
pharmacological effects)
Dilution or potentisation increases effect            § 286-287
Standard products…
   In other words standard products, in natural
    form,   in its   totality,   in   dose to   initiate
    mechanism of cure by qualitative action mainly
    in “dose” which does not have side effects.
   Methods for testing the products for their purity
    and absence of impurity form the basis of
    pharmacopoeia.
Pharmacopoeias
 Dr. Caspari (1825) and Dr. Willmar Schwabe (1872)
 did leave pharmacopoeias but it was AHP 1897
 which seriously dealt with individual drugs, its
 identification & preparation . HPUS 1941 was taken
 up by the FDA Act 1938 (In India Drugs were
 controlled in 1940). HPI came in 1971 with methods
 of preparation and 180 monographs of drugs. With
 this the homoeopathic pharmacy shifted from “art” to
 “science”.
Legal aspects of homoeopathy
in India
Homoeopathy in India comes under Drugs and Cosmetics
  Act. It recognises the following pharmacopoeias:
1. Homoeopathic Pharmacopoeia of India (HPI)
2. British Homoeopathic Pharmacopoeia (BHP)
3. Homoeopathic Pharmacopoeia of United States (HPUS)
4. German Homoeopathic Pharmacopoeia (GHP)
French homoeopathic pharmacopoeia is not recognised, but
   it has valuable information on nosodes and
   organotherapies (sarcodes)
The Drugs and Cosmetics Rules
1945
 “Homoeopathic medicines” include any drug which is recorded
 in Homoeopathic provings or therapeutic efficacy of which has
 been established through long clinical experience as recorded
 in authoritative Homoeopathic literature of India and abroad and
 which is prepared according to the techniques of homoeopathic
 pharmacy and covers combination of ingredients of such
 Homoeopathic medicines but does not include a medicine
 which is administered by parenteral route.
Sources of homoeopathic drugs
Earlier          Now
Plant sources    Allersodes
Animal sources
Minerals         Isodes (tautopathic
                 medicines can be
Nosodes          classified along with
Sarcodes         isodes as the method
                 of preparation is same)
Imponderabilia
Sources…
Sarcodes   Properly identified healthy organs or
           tissues
           Needs healthy certificate & genuinity by
           experts before a drug is made (legal need)
Imponder- No more vague. In revision series of HPUS
abilia     like for X-Rays. 1 liter or 1 kg is exposed to
           1000 X-Ras rads to make basic material for
           use. It is then diluted as 1/100 and product
           is equalant to 2x
Nosodes – methods of
preparation

N1 for the lysate of bacteria producing endotoxins (e.g..

  Typhoid, paratyphoid, e.coli)

N2 for bacteria producing exotoxins (e.g.. diphtheria)

N3 for pure organisms (e.g. tuberculinum pure culture)

N4   for   preparations   from    tissues   (e.g.   psorinum,

  bacillinum)
Gradual enforcement of Act &
Rules
Homoeopathic medicines were
defined in Drug Rules (Rule 2 dd)   1969

Homoeopathic pharmacopoeia
covered in the second schedule
of the act                          1978
Homoeopathic drug proving (HPI
Volume 1)
1.   Controlled experiment
2.   On relatively healthy volunteers
3.   Substances should be prepared as per general
     methodology mentioned in the pharmacopoeia
4.   Experiments should be in varying doses to produce the
     data called „proving‟
5.   On the scheme and pattern to constitute Materia
     Medica Provings are the basis of Materia Medica
6.   Experiments should be carried only to extent of causing
     gross temporary reversible alterations and sense
     perceptible objective signs.
Unique characteristics of
homoeopathic drug standards
1. The raw material should be same as used in
    the proving.
2. Method of preparation should be one
    adopted by the prover.
This in turn means:
1. Go for the correct species, adopt microscopic
    / histopathological studies.
2. Fix the percentage of active & limits for
    inactive constituents and aducterants.
Process has a bearing on the
quality
Trituration - particle size 10 micron at 1x level
Tincture    - fresh or dry plant
            - size of cut or fineness of the
            powdered material
            - percolator packing
            - percentage of extraction
            solvent
            - rate of percolation
            - time of maceration
Supplementary but essential
standards
Ash values
Extractive values
Saponification values
Reaction (pH) of known strength solution
Foreign matters
Moulds, fungus, bacterial, pesticide residue TLC
  Rf values
Tincture, odour, taste, colour & dry residue
Triturations / tablets
   Insoluble basic drug materials (1:10 or 1:100) with
    lactose
   Triturated by hand or machine. Particle size of the
    basic drug material in the final decimal or centesimal
    dilution has to be below 10 µm for 80%; no drug
    particle should be more than 50 µm.
   Trituration time: Minimum 1 hour.
   One third of the lactose is given into the mortar, then
    the basic material is added; finally the remaining
    vehicle in two equal portions is added and triturated.
Triturations / tablets                contd…
   For tabletting permitted excipients are only
    starch – concentrated up to 10 percent and
    magnesium stearate in concentrations up to 2
    percent.
   Granulation if necessary has to be done with
    saturated lactose solution, starch paste or
    ethanol.
   Tablets are single doses containing 250 mg of
    the trituration. The weight of excipients goes
    additional.
Lowest potencies – legal limits
of prescription
Name of the drug   Legal position
Antim. ars.        Not below 3x
Ars. Alb.          Not below 3x
Ars. Iod.          Not below 3x
Ars. Sul. Flv.     Not below 2x
Ars. Sul. Rub.     Not below 2x
Baryta carb.       Not below 3x
Baryta mur.        Not below 3x
Bufo rana          Not below 3x
Calcarea ars.      Not below 3x
Lachesis           Not below 6x
Lowest potencies – legal limits
of prescription        contd…
   All arsenic, barium, mercury and lead – not
    below 3x
   All nosodes - not below 6x (3rd potency) for
    trading, not below 6th potency in practice
   All snake, viper, spider, toad and insect
    poisons - not below 3x (exceptions in India –
    Blatta orientalis Q)
   Phytochemicals (HCN glyc.) etc. – not below
    6x
Special storage conditions (up
to 3x)
   Acidum aceticum, nitricum,      Hydrastis
    picrinicum and sulphuricum
                                    Iodium
   Apis mellifica
                                    Physostigma
   Bromine
                                    Rauwolfia
   Creasole
   Gelsemium                       Secale cor.
                                    Zincum aceticum
Stringent storage condition (up
to 3x)

   Arsenic             Naja

   Acid fluric         Nitroglycerine
    (hydrofluric)       Merc. Iod. Flv.

   Atropine sulph      Merc. Iod. Rub.

   Chininum ars.       Phosphorus

   Lachesis
Level of testing in
homoeopathic drugs
Biochemic drugs - up to 6x; up to 12x by plasma
Triturations      - up to 6x; up to 12x by plasma
Mother tinctures - up to 4x; up to 6x by HPLC
Mother tinctures - up to 2x in combinations
Combination drugs - up to 2x
Ointments, hair oils, eye drops, etc.
Dilutions         - up to 6x
Level of testing in
homoeopathic drugs                   Contd…
     Molecules are present at best up to level 12C
      or 24x
     But clinical response is visible even above
      24x in
    •    Human being
    •    Animals
    •    Bacteria
    •    Plants
     Biological response can be demonstrated on
      polygraph and other sensitive equipments
      used in experimental pharmacology
  No. of homoeopathic drugs covered by
  different materia medica & other literature

Materia medica                    No. of drugs covered
Materia Medica Pura –             75 approx.
Hahnemann
Lectures on Materia Medica –      206
J. T. Kent
Encyclopedia of Pure Materia      720
Medica – T. F. Allen
Dictionary of Practical Materia   1010
Medica – J. H. Clarke
Pocket Manual of            1235 + 200 in footnote
Homoeopathic Materia Medica
and Repertory – W. Boericke
No. of homoeopathic drugs covered
by different materia medica & other
literature                  contd…
Homoeopathic Pharmacopoeia 845 (total no. of monographs
of India                   is 916, but it has repetition of
                           many drugs in subsequent
                           volumes)

Homoeopathic Pharmaceutical 101
Codex, volume 1

Homoeopathic                    2373
pharmacopoeial list (Govt. of
India)

HPI drug documentation file     4400
OLD METHOD – No more used
Hahnemannian classification of
mother tincture preparation
Class        Ratio of vehicle          Drug       Drug under the class
                                       strength
Class I      Juice:alcohol 1:1         1/2        Belladonna
Class II     Plant:alcohol 3:2         1/2        Thuja
Class III    Plant:alcohol 1:2         1/6        Scilla
Class IV     Dry Plant:alcohol 1:5     1/10       Spigelia
Class V A    Aqueous solution 1:9      1/10       Acid phos
Class V B    --do– poisonous 1:99      1/100      Hydrocyanic acid
Class VI A   Alcoholic solutions 1:9   1/10       Chromic acid
Class VI B   --do– poisonous 1:99      1/100      Arsenicum
Class VII    Trituration 1:9           1/10       Strychninum ars.
Class VIII   --do– liquid subs. 1:99   1/100      Petroleum
Class IX     --do– veg & animal 2:99   2/101      Agaricus
New concept: On uniform drug
strength…
Materia Medica Pura Vol II pg 30 or Chronic
  Diseases pg 182 :
   “In order to make alcoholic medicinal
    substances of uniform strength and to obtain
    from them determinable dilution follow….”
BHP part I pg 11 & 12 :
   “In every substance the dry crude substance is
    to be taken as starting point for calculation of
    strength.”
    German Homoeopathic
    Pharmacopoeia
Method   Proportion                              Drug strength


I        Juice + alcohol 86%                     1:1


II A     Fresh drug + alcohol 86%                1:2




                                    Maceration
II B     Fresh drug + alcohol 30%                1:2


III A    Fresh drug + alcohol 60%                1:2


III B    Fresh drug + alcohol 73%                1:2


III C    Fresh drug + alcohol 43%                1:2
 German Homoeopathic
 Pharmacopoeia       Contd…
Meth-                                                             Drug
od       Proportion                                               strength
IV A     Dry drug : alcohol 1:9                                   1/10

IV B     Dry drug (animal products) : alcohol 1:9                 1/10

VA       Solutions – alcohol, water or glycerol 1/10 or 1/100     1/10 or 1/100

VB       Solution aqueous water for injection 1/10 or 1/100       1/10
VI       Trituration 1/10 or 1/100                                1/10
VII      Trituration of MT or MS 1x
VIII     Liquid from trituration 8x or 4C
VIII B   Liquid from trituration – in water for injection
IX       Tablets permitted starch up to 10% calcium bihanate or
         magnesium stearate 2%
     German Homoeopathic
     Pharmacopoeia       contd…
Method Proportion                                         Drug
                                                          strength
X        Granules
XI       Liquid dilution for injection
XII A    External application MT (alcohol 30-43%)         1/10
XII B    External application MT (alcohol 73%)            1/10
XII C    External application MT (alcohol 20%)            1/10
XII D    External application MT in oil 60-70°C 4 hours
XII FL   External application MT in oil under CO2 37°C
         7 days
XIII B   Ointments – antioxidants, stabilizers are not
         permitted
         German Homoeopathic
         Pharmacopoeia       contd…
Method                   Preparation
XIV                      Suppositories – antioxidants, stabilizers are not permitted
XV                       Eye drops – Isotonic, sterile, preservatives permitted
XVI                      Mixtures
XVII A                   LM potencies
XVII B                   LM potencies in granules
XVIII A,B,C,D,E&F        Heat treated liquid tinctures
XIX A,B,C,D,E&F          Refluxed tinctures
XX                       Refluxing and cooling – Rh MT
XXI, XXII, XXIII& XXIV   For different set of alcohol % - Rh MT
XXV to XXXVIII           Spagric MTs – fermented products
XXXVII to XXXIX          Coated granules
XL (40)                  Potentised mixtures
XLI to XLVI              Nasal drops, i.v. drops, etc
French Homoeopathic
Pharmacopoeia

Gemmotherapie (extraction in glycerine) – 56

Organotherapie (parts of the body – similar to

  sarcodes) – 261

Lithotherapie (from crude minerals) - 43
   Quotation from HPI Vol II
   “The old Hanemannian method of preparation has been
   discarded in favour of a new uniform method with specific
   drug strength which takes in to consideration the moisture
   content of the drug, thus eliminating the variation in
   standards. This method (the new uniform method of
   preparation of tincture as mentioned in the General
   Instructions    for    preparation    in     Homoeopathic
   Pharmacopoeia) is applicable to most* of the drugs and has
   been accepted by the committee”.
*A few exceptions have been taken care in the individual monograph
GMP
There have been amendments to
Drug    Rules   in   October   2006
affecting homoeopathic medicines
– Good Manufacturing Practices
(GMP)
GMP
Government     now   differentiates
single medicines and formulations

It now differentiates indirectly low
potencies and high potencies
GMP
   It now requires that the containers
    should     be     neutral     glass

   In the manufacturing area no
    spitting,       smoking,      chewing,
    littering, etc. are permitted.
GMP
A   standard   operating   practices

(SOPs) is required for all processes,

drugs and material movements.
GMP
The manufacturer shall use back-
potencies   procured   from     licensed
manufacturers   and    the    firm   shall
maintain proper records of purchase or
shall prepare own back-potencies with
records.
GMP
   Different droppers shall be used for
    different  medicines    and  different
                  potencies.

   Potentisation shall be done using
    Hahnemannian method (change of bottle
    at each stage of potentisation)
GMP
In case of formulation the following has been added:
   Compound formulations shall preferably be in liquid and
    solid forms and the potency of the ingredients shall be in
    detectable quantity preferably be in 3x except in case of
    highly poisonous material and toxins which should not be
    below 6x.
   The ingredient shall be compatible to each other.
   Complete pharmacopoeial name of each ingredient shall
    be printed on the label along with composition.
GMP
In case of Laboratory Controls the following the following has
    been added:

   Tests as per the pharmacopoeia and requirements shall be
    carried out on products and materials.

   The stability of the products shall be established by proper
    methods.

   Sterility tests, wherever applicable, shall be carried out.

   Control samples shall be preserved for not less than three
    years after the last sales.
GMP
For the first time expiry date

for homoeopathic medicines

has been prescribed.
Thank
 you.

				
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