Decision Tree on Topical Dosage Form Nomenclature Version #7 by G1A988C3

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									                                  Decision Tree on Topical Dosage Form Nomenclature
                                                        2/12/03


                             A topical
                           dosage form
                        for dermatological
                            application




                                  Is it
                            an emulsion in
                       a liquid preparation or                                                                                         Solution,
                                                     No
                     an emulsion or suspension                                                                                     aerosol, powder,
                            in a semisolid                                                                                          or suspensiona
                             preparation?


                                   Yes



                                  Does                                 Does
                               it contain                           it contain
               Yes      sufficientb quantities    No           a large proportion       Yes
 Gel                    of a gelling agent to                     (20-50%) of                                                               Paste
                              form a 3D                             dispersed
                                matrix?                               solids?


                                                                         No

                                                                                                           Does it
                                                                     Does                             contain (1)  50
                                                                  it contain                         of hydrocarbons or
                                                                                      No                                       Yes to
                                                              > 50% of volatiles                  PEGe as the vehicle and                  Ointment
                                                               as measured by                      (2) < 20% of volatiles       both
                                                                    LODc?                              as measured by
                                                                                                           LODc?

                                                                        Yes
                                                                                                               No to
                                                                                                               either
                                                                    Is it a                                    or both
                                                   Yes         pourable liquid
Lotion                                                        with a viscosity of
                                                                30,000 cpsd?



                                                                         No


                                                                    Cream




  a
       A liquid preparation that consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble.
  b
       See definition table for references.
  c
       USP loss on drying test, 105C until constant weight is achieved.
  d
       When measured with Brookfield viscometer at 25C and 5 rpm
  e
       Polyethylene glycol

								
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