DESIGN & DEVELOPMENT OF SOLID SELF MICRO-EMULSIFYING OSMOTIC DRUG DELIVERY SYSTEM FOR ISRADIPINE
Objective: The objective of the study was to design and develop self-microemulsifying osmotic pump tablet Isradipine, a BCS Class IV antihypertensive agent for improved solubility and obtain controlled release characteristics.
Material & Methods: Methodology for undertaken project involved pre-formulation studies, comprising of analytical method adoption and drug: excipient compatibility studies. Further steps involve formulation and characterization of liquid SMEDDS of Isradipine. Developed SMEDDS was incorporated into selected adsorbent and compressed with osmotic agents, a binder and lubricant into tablet. Tablets were film coated with semi-permeable membrane and drilled with orifice. Final formulation was optimized for various formulation components and evaluated on various dimensions, among dissolution profiling and stability studies.
Results and Discussion: Solubility studies in oils, surfactants and co-surfactants were carried out and SMEDDS formulation was finalized as Isradipine (11.63%), Gelucire 50/13 (34.88%), Lutrol F127 (30.23%) and Transcutol P (23.26%). Neusilin US 2 was selected as adsorbent in 1:1 ratio based on excellent adsorption and huge surface area. Final optimized formulation of tablet comprises of core tablet and functional coatings of cellulose acetate (60%) and PEG 400 (40%) with 5% film coating build up. Developed formulation was optimized for various formulation components and evaluated for release kinetics and accelerated stability study.Conclusion: The developed novel SME-OPT of Isradipine will be a promising template for formulating controlled release dosage form of BCS Class II and IV bioactive agents. The technology used for the preparation of SME-OPT is relatively simple manufacturing technology which can be easily adopted in industrial units on a commercial scale.
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