A PROCESS FOR MAKING A PHARMACEUTICAL STABLE FORMULATIONS FOR S
Application 755/MUM/2003 published 2006-05-05, filed 2003-07-31
The present invention is concerned with process of making stable pharmaceutical formulation of tablet comprising an effective amount of S (-) amlodipine desolate with pharmaceutically acceptable & compatible (physical & chemical) percipients characterize in that chemically compatible stable percipient is Declaims phosphate anhydrous and other percipients like microcrystalline cellulose, Sodium starch glycol late, Polyvinyl pyrrolidone (K10 to K120), lake of quinoline yellow, colloidal silicon dioxide and magnesium Seagate either alone or in combination result in tablet formulation which on and during shelf life minimizes the inter conversion of S (-) isomer to R (+) isomer less than 0.01% & not more than 0.15% of the total dose thereby reducing or nullifying the side effects caused by the R (+) isomer and degradation products within the limits and shows the best in vitro dissolution profile studies even up to 6 months studied at 40º C/75% RH accelerated conditions as per ICH guidelines & showing excellent tabulating properties, good mach inability in production scale. Our developed process also offers consisting of angiotensin-converting-enzyme inhibitor, an angiotensin II inhibitor, a calcium inhibitor, beta –adrenergic antagonists in tablet formulation, belayed tablet formulation and tablet in tablet formulation by using suitable recipients to minimize the contacts between active molecules and Drawing: 00 Sheets. Total Pages: 27. Fig. Nil
Applicant
ARISTO PHARMACEUTICAL LTD.
COMPANIES ACT 1956, REGISTERED OFFICE AT 12, J N HEREDIA MARG, BALLARD ESTATE, MUMBAI – 400001
Inventor
1. MR. MANUTOSH MANOHAR ACHARYA. 2. MR. ABHAY SHIVAJIRAO PAWAR. 3. MR. SURESH KUMAR PASWAN.
International Info
Classification: A 61 K 31/44 C 07 D 213/16