Abstract

SPIRONOLACTONE-EXCIPIENT COMPATIBILITY STUDIES FOR ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT

Mahmoud Mahyoob Alburyhi*, Abdalwali Ahmed Saif and Maged Alwan Noman

ABSTRACT

Emulgel is a combination of emulsion and gel, and can deliver both hydrophilic and lipophilic drugs due to the presence of both aqueous and non-aqueous phases. In recent years, they have been used as a control release formulation. These are biphasic systems that have better drug loading capacity and better stability. Spironolactone is androgen receptor blocker, inhibitor of 5-a reductase and aldosterone antagonist, used to treat acne vulgaris orally, but in our research, we formulate and evaluate Spironolactone in drug delivery system as ―Emulgel‖ to avoid adverse effects of anti-androgenic action of Spironolactone with males and avoid diuretic action. The main objective of the present study was to the preformulation studies were performed to know the development of formulation and evaluation of Spironolactone Emulgel for topical application. In the present study that the compatibility was assessed by, FTIR spectroscopy, and melting point apparatus, preformulation parameters. Results showed that physical mixtures of Spironolactone and various excipients such as (acrypol 940, HPMC, liquid paraffin, isopropyl alcohol, vitamin E, ethanol, tween, emulgen B, menthol, aloevera, PEG400, EDTA, Na methyl paraben, Na propyl paraben and lime fragrance) were evaluated for preformulation studies parameters. It was concluded that the drug Spironolactone was found to be compatible with various excipients which were selected for the formulation development of the Spironolactone Emulgel. Formulation scientist from his experience and knowledge have to significantly in the preformulation study stage and is an important factor in the ADDS (Advanced Drug Delivery Systems) product development process.

Keywords: Spironolactone, Compatibility, Excipients, Development, Preformulation, Emulgels.