ACTA FAC MED NAISS 2012;29(1):23-30

Original article

UDC:615.014.2:615.256:618.15-08

Development of Formulations for Vaginal Gel Carrier in the Pharmacy - a Regulatory and Quality Aspect

Milica Stanković¹, Vesna Savić¹, Valentina Marinković²

¹University of Niš, Faculty of Medicine, Department of Pharmacy, Serbia

²University of Belgrade, Faculty of Pharmacy, Serbia


SUMMARY

On the basis of the Law on Medicines and Medical Devices of the Republic of Serbia, a magistral medicine means a medicine prepared in the pharmacy according to a prescription (formula) for an individual patient - user. In practice, the more need is for ex tempore production of vaginal preparations in the pharmacy and galenic laboratory. Due to the small number of registered vaginal gel products on the world market, and even less on our own market, their production in the pharmacies is very important. The aim of this study was to examine the possibilities of development the vaginal gel carriers with different hydrophilic polymers, in the pharmacy, in accordance with the requirements of the European Pharmacopoeia. For their production we used three different mediums for gelation: Carbopol® 940, Carbopol® Ultrez 10 and Pemulen® TR 1 NF. All formulations show similar organoleptic properties during the observed period of time. Measured pH values of carrier formulations do not differ significantly compared to the normal pH values of vaginal fluid. Optimal value for viscosity has a formulation A1 (formulation with Carbopol® 940), thus that formulation is our recommendation for the development of vaginal gel carrier. Because of the complicated procedure of registration of the generic drug, recommended formulation for vaginal gel carrier, as magistral medicine, has a great importance for patients who require precise adjustment of therapy.

Key words: magistral medicine, carrier, vaginal hydrogel, legislation, viscosity