For the treatment of gastrointestinal ulcers, raft forming systems incorporating Nizatidine were developed to provide sustained drug release and prolong gastric residence time. The raft forming formulations contained Nizatidine as a raft forming agent, Isabgol as a gelling polymer and sodium bicarbonate as an agent to generate gas and calcium carbonate as an agent to strengthen gels. Sodium bicarbonate, along with divalent Ca++ ions, forms a floating raft loaded with drugs. Raft formulation was optimized by applying Full Factorial Design of 33. Testing was done on all batches for pH, In-Vitro Floating, Raft strength, Acid Neutralizing capacity, viscosity, and drug release. The majority of formulations using Isabgol as a gelling agent have a gelled raft in less than 2 minutes and are buoyant for more than 8 hours in 0.1N hydrochloric acid having pH 1.2. Optimized batches show good administration capabilities and better stability over six months. The studies conducted suggested that raft forming systems made from natural polymers carrying drugs could be used to deliver gastroretentive drugs.
For simultaneous estimation of Azelnidipine and Telmisartan in pharmaceutical dosage form, a simple, rapid, precise and reproducible RP-HPLC method was developed. Separation was achieved on a Phenomanax Luna C18; 5 μm, 150 mm × 4.6 mm i.d. column using water and methanol 50: 50 (v/v) as mobile phase and detected at 256 nm using PDA detector. Azelnidipine and Telmisartan were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions and stressed samples were analyzed by the proposed method. Linearity, precision, accuracy, specificity and robustness were studied as reported in the International Council for Harmonization guidelines. Linearity of the proposed method was in the range of 4-12 μg mL-1 (r2 = 0.998) for Azelnidipine and 20-60 μg mL-1 (r2 = 0.997) for Telmisartan. Limits of Detection were 1.041 μg mL-1 and 0.208 μg mL-1, while Limits of Quantitation were 3.155 μg mL-1 and 0.631 μg mL-1 for Azelnidipine and Telmisartan respectively. Degradation products produced as a result of stress studies did not interfere with the detection. The proposed stability studies method for simultaneous estimation was found to be specific, accurate and economical that could be applied for routine analysis of drugs in bulk and multi component formulations in quality control laboratories.
Glimepiride (GM) is third generation sulfonylurea group and preferably used for the treatment of type -II diabetes mellitus. It belongs to BCS class II drugs according to biopharmaceutical classification system which shows low aqueous solubility. The purpose of this work was to develop and optimize glimepiride loaded chitosan- tripolyphosphate nanoparticles by ionotropic gelation method using 32 full factorial experimental designs. The developed chitosan nanoparticles were evaluated for particle size, zeta potential, entrapment efficiency, %yield and in vitro drug release etc. Factorial experimental design was implemented to optimize the independent variables like drug: polymer ratio (X1) and concentration of cross linking agent (X2) on dependent variables like particle size (Y1) and entrapment efficiency (Y2). A statistical analysis was performed using minitab 16 software with respect to ANOVA, regression analysis. The surface plots and contour plots represent the relationship between the experimental responses and the set of independent variables. The factorial experimental design was validated by checkpoint analysis and desirability function approach was applied for optimization of chitosan nanoparticle formulation. Drug entrapment efficiency and mean particle size of optimized formulation was found to be 61.25% and 222 nm respectively. Nanoparticles revealed initial burst release followed by slow drug release.
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