Bhushan S. Gulecha

  Gastro retentive drug delivery system has been widely used to prolong retention of dosage forms in stomach. Amongst the various approaches, the Raft formulation offers sustained drug release as well as prolonged gastric retention, along with the added advantage of liquid oral dosage form. The present study was an attempt to formulate and evaluate Raft forming floating drug delivery system for Verapamil Hydrochloride which undergoes pH dependent sol-gel transition at gastric pH; thereby prolonging the retention of the system in stomach. Gellan gum (Gelrite®) was employed as gelling agent whose gelation is triggered by source of Ca2+ ions in the form of Calcium Carbonate. The evaluation was carried out for In Vitro parameters and the results substantiated that the optimized formulation revealed excellent floating characteristics and gastric retention.

  The objective of designing a dosage form is to achieve predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. In order to ensure quality of product various features are required, like chemical and physical stability, preservation against microbial contamination, uniformity of dose of drug, acceptability to users including prescriber and patient, as well as suitable packing, labeling, and validation. The present research work focused on prospective process validation for the gliclazide 40mg tablet. Tablet was manufactured by wet granulation method. Formulation of tablet using Maize Starch, Avicel Ph 102, PVP-K30, sodium starch glycolate, Purified Talc, Aerosil 200 and  Magnesium stearate. Uniformity of dry mixing is excellent in 10min because % RSD found to be 0.4267-0.9021%. Granulating agent was prepared of desired consistency. Drying time 30 min is sufficient to achieve LOD 2-3%. Evaluation parameter of sizing shows effective LOD, % fine, BD & CI. Lubrication stage uniformity was achieved with 10min because % RSD found 0.8320-1.032% and flow properties was satisfactory. Compression machines optimum speed (20RPM) was satisfactory for effective compression. Based on results at each of the stages for the specified parameters it is concluded that gliclazide tablets can be effectively prepared with the desired specification & reproducible quality standards.