DESIGN & DEVELOPMENT OF SOLID SELF MICRO-EMULSIFYING OSMOTIC DRUG DELIVERY SYSTEM FOR ISRADIPINE
Abstract
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.DOI
https://doi.org/10.22270/jddt.v0i0.903Published
Abstract Display: 708 
PDF Downloads: 915 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.