Category: Fellows Posters
Sucralfate suspension was designed and commercialized for peptic ulcers as a product for oral use. But, in fact, it is also commonly used as topic treatment for cutaneous wounds, as well as for mouth and genital thrush. Because of the shortage of Urbal™ in Spain, the dermatology service asked the pharmacy service for a magistral preparation which would solve that problem. The aim of this study consists on the development and validation of the Sucralfate 20% topic gel the pharmacy service made in answer for the commercial drug shortage, as well as stablish a normalized work protocol.
The reference to design the composition of the preparation was the commercialized sucralfate suspension as well as other sources of information: reviews and articles. Storage conditions and beyond-use date were stablished based on the “Guide to Good Practices for the Preparation of Medicines in Hospital Pharmacies”, published by the Minister of Health of Spain for aqueous non sterile and non-oral preparations. The galenic validation was carried out following the own technical instruction for this process. Ten characteristics in the preparation were evaluated as follows: (I) color, (II) odor, (III) transparency, (IV) evanescence, (V) cooling effect, (VI) extensibility, (VII) viscosity, (VIII) homogeneity, (IX) exudation and (X) pH. Points I to IX were determined by visual inspection and the last one, (X) pH was determined by potentiometry. Each of these characteristics were evaluated once per week during four weeks, in days 1, 8, 15, 22 and 30.