Sterile Topical Dosage Forms I: Laboratory Phase

Effect of Gamma Radiation on Rheological Properties of Pharmaceutical Semisolids

“…As a consequence, it is now well-accepted that semisolid ointment vehicles for the administration of drugs t o the eye should be sterile (British Pharmaceutical Codex 1963). Similar requirements have also been applied in some countries to topical semisolids, e.g., dosage forms containing steroids (Polli et al 1972).…”

“…For instance, some bases are thermolabile and cannot be sterilized by heating. Filtration of molten bases under pressure through millipore filters is an alternative procedure, but in practice this is difficult because of filter blockage problems and unacceptably low filtration rates (Boylan 1973; Polli et at. 1972).…”

“…The literature contains few pertinent reports, even for the more conventional methods of sterilization (Polli et al 1972). Hangay et ul.…”