Verapamil Hydrochloride is indicated to control blood pressure in individuals due to postural and nocturnal–diurnal variations in the biological clock. The once-daily administration of Verapamil Hydrochloride is handy for patients to comply with the dosing regimen prescribed. This research aims to develop stable, bio-equivalent, cost-effective, and commercially feasible Verapamil Hydrochloride extended-release tablets, 120 mg, 180 mg and 240 mg. Inorder to achieve this aim, our objective was to explore a simple aqueous granulation involving conventional excipients viz. Sodium Alginate, Povidone, Microcrystalline Cellulose and Magnesium Stearate. The drug to polymer ratio of 1:1.35 was found to be optimum. Every unit operation involved in the process was completely optimized to achieve reproducibility and to avoid drug release variation. The designed process was scaled-up from a batch size of 75,000 tablets to 750,000 tablets. During scalability, no difference is observed in the physico-chemical characteristics of the blend or tablets. The blend and content uniformity results were found to comply with USP requirements. The manufactured product was found stable in bottle and strip packs at accelerated stability conditions for 6 months. The maximum level of the highest unknown impurity observed was 0.1% and is well within the ICH Q3BR3 requirements. Hence based on stability study results, shelf-life storage of 24 months at controlled room temperature was prescribed for the product. The end product was found to be more cost-effective (3.2 to 6.4 Indian rupees) than the brand product available nationally (within India) priced at 4.7 to 9 Indian rupees, and the physico-chemical characteristics, drug release, and stability of the manufactured drug product were comparable to the brand product available in the USA market. The similarity factor 'f2' was found to be more than 75. In the Pharmacokinetic study, the test to brand product ratio at 90% confidence interval was within 80.00-125.00%, exhibiting the developed product's bio-equivalence with the brand product. Novelty in this research is in the comprehensiveness of work done to demonstrate stability, bio-equivalence, cost-effectiveness and commercial ability aspects which were not reported elsewhere in the already published research work on Verapamil extended release tablets.

In this research an attempt was made to develop and evaluate a commercially feasible and cost-effective tablet and oral suspension of Solifenacin Succinate. In international market, Solifenacin Succinate is available in both tablet and oral suspension dosage form. In Indian market, only tablet dosage form is available. Hence it was decided to make a formulation of Solifenacin Succinate that will not only be used as an oral solid dosage form in the form of tablet but also can be readily converted to oral suspension by extemporaneous means. A simple direct blending process was followed using limited excipients to make the end product cost-effective. The finalized product was comparable to the international brand product with respect to physico-chemical attributes, drug release and stability. The prepared tablet was made into an oral suspension using Ora-Plus® and Ora-Sweet® and the compounded suspension showed good palatability, organoleptics, chemical and microbial stability.

Pregabalin is indicated for epilepsy. Pregabalin drug product is available in market as Solution, Capsules and Extended Release tablets. This research aims to formulate a stable composition and process for Pregabalin Capsules that exhibits comparable physico-chemical characteristics to brand product capsules. Before initiating the formulation work, API and Brand product was completely characterized. Excipients were selected based on the brand product characterization and Drug-Excipient compatibility study. Based on the API characterization, brand product characterization and Drug-Excipient compatibility study, preliminary formulation work was initiated. A direct blending process was followed for final blend preparation. The final blend was filled into capsule shells using ACG-Pam MF-30 capsule filling machine. During stability evaluation of different prototypes at accelerated storage condition of 40°C / 75% RH, the formulation containing Colloidal Silicon Dioxide showed higher level of impurity, Pregabalin Related Compound-C (4-Isobutylpyrrolidin-2-one) or Pregabalin Lactam Impurity. The observation of incompatibility of Pregabalin with Colloidal Silicon Dioxide was doubly confirmed by Drug-Excipient compatibility studies. When the incompatibility reaction was investigated at molecular level, it was observed that one mole of water gets released when Pregabalin reacts with Colloidal Silicon Dioxide. This was further confirmed by mass balancing the molecular weights of reactants, Pregabalin and Colloidal Silicon Dioxide with the product, Pregabalin Related Compound-C. Thus the final formulation was made without Colloidal Silicon Dioxide and has Lactose Anhydrous as diluent; Pregelatinized Starch as Binder and Disintegrant; and Talc as glidant and lubricant. The drug product showed comparable physico-chemical characteristics with brand and also found to be stable.