Sodium starch glycolate

ABSTRACTThe scenario of pharmaceutical drug delivery is rapidly changing. Conventional pharmaceutical dosage forms are being replaced by new drug delivery systems. These new drug delivery systems are having border over conventional ones in terms of many biopharmaceutical parameters. One such drug delivery system is bilayer floating sustained release drug delivery system. The research envisaged in the present study is an attempt towards developing a formulation of anti-diabetics and anti-hypertensive drug in a single dosage form. The main aim of present study is to formulate and evaluate bilayer tablets of Amlodipine Besylate as IR and Metformin Hydrochloride SR combination tablets for effective treatment of type II diabetes mellitus and hypertension. Preformulation studies including drug excipient compatibility were conducted for both drugs. Different formulations of sustained release, floating Metformin HCl tablets were prepared by using hydrophilic polymers like HPMC K100M, HPMC K4M etc., were evaluated. Amlodipine immediate release formulations were prepared using sodium starch glycolate as superdisintegrant and starch as disintegrant and were evaluated. Based on the in vitro dissolution data F6 and F3 were selected as the best formulations from Metformin and Amlodipine formulations respectively. From the bilayer tablet Amlodipine layer disintegrated within 5min , Metformin layer started floating after 5 min and showed total floating time ?12 hrs with good swelling index, good post compression parameters. In vitro dissolution study of bilayer tablet was done in USP type II along with UV spectrophotometer bestowed cumulative % drug release of Amlodipine as 98.75% at 30 min and 99.32 % of Metformin at 12 hrs. From the study it was found that, HPMC K100M showed good sustained release for 12 hrs. Among the disintegrants used sodium starch glycolate and starch showed good disintegration of Amlodipine layer. Overall this FDC formulation could be more effective, conveni

Telmisartan is an angiotensin II (AT1) receptor antagonist used in the treatment of hypertension. The drug is practically insoluble in water and insoluble in the pH range 3-9. The principal aim of this work is to improve the dissolution profile of telmisartan by solid dispersion and to find out the effect of sodium starch glycolate and β – cyclodextrin on the dissolution profile of telmisartan tablets. The study also includes optimization of the amount of sodium starch glycolate and β – cyclodextrin by a 32 full factorial design. Other excipients used in the study are microcrystalline cellulose (Avicel PH-101), D- mannitol, magnesium stearate and talc. Both sodium starch glycolate and β – cyclodextrin had contribution towards the enhanced release profile of telmisartan (about 80 % drug is released in 40 minutes) but the effect of β – cyclodextrin is more pronounced as revealed from response surface plots as well as from their corresponding contour plots. The optimized amount of β – cyclodextrin and sodium starch glycolate was found to be 2.0 gm and 1.6 gm respectively. The predicted and observed responses for the optimized solid dispersions shown no significant difference (paired t-test, p – value = 0.2834 and 0.3403 for percentage drug released at 20 and 40 minutes respectively).