FORMULATION AND STABILITY OF HEPTAMINOL SUPPOSITORIES

Kassem, A. A.; El-Miligi, M. F.; Ali, S. A.

doi:10.21608/bfsa.1984.89535

FORMULATION AND STABILITY OF HEPTAMINOL SUPPOSITORIES

Document Type : Original Article

Authors

Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Cairo, Egypt

10.21608/bfsa.1984.89535

Abstract

The chemical stability of Heptaminol Base and of Heptaminol Hydrochloride was determined after shelf-life storage in an aqueous solution at room temperature. Under these conditions, the Base was found about 10.54 times more stable than the hydrochloride. Heptaminol Base, therefore, was formulated in four different suppository bases. The prepared suppositories were subjected to the usual quality control tests, both when fresh and after shelf-storage for one year. The results of physical examination were so variable that a sharp conclusion to a preferred formula was not possible, However, studies of medicament dissolution revealed that quick and full-dose release of heptaminol was achieved from glycerogelatin based suppositories. On the other hand, suppositories based with polyethylene glycols have shown a prolonged heptaminol dissolution rates. The chemical stability of the medicament In the four different suppository bases was also investigated in absence and presence of several, stabilizers. The stability was found decreasing in the order of: Clycerogelatin, Cacao-Butter, Witepsol-E-75, and then Poly-ethylene Glycols. Butylated hydroxyanisole (BHA) was the best stabilizer in the two fatty-based formulae, while tocopherol succinate was the best stabilizer, while the mixture of sodium formaldehyde sulfoxylate (SFS) with sodium edetate was the worst.