Formulation development studies determine the optimal dosage form, composition and manufacturing route is a fundamental part of pharmaceutical product development. Getting pharmaceutical formulation development right helps to optimise drug delivery performance and product stability. Complex dosage forms, in particular, inhaled and nasal products can present unique challenges for controlling the performance of the drug product and impact bioavailability. At GVK BIO, we recognize the importance of our clients’ requirement to develop robust and compliant formulations. Our formulation development services focus on both generic as well as NCE formulations, which fulfill regulatory requirements of targeted markets, possess attributes sought after by medical practitioners and meet customer’s performance metrics.
GVK BIO has the right equipment, facilities and highly dedicated formulation development specialists to help you arrive at the optimal dosage form for your API and application. We ensure any forms we develop are scalable, compliant and commercializable for our customers. We adopt a comprehensive, time-bound strategy in developing stable products that are efficient in all quality aspects. Our formulation development team enables small amounts of drug product materials to be developed using experimental design methodologies supported by testing at every stage with key performance analytics including solubility, dissolution, solid state characterisation and powder and particle morphology studies.
We work on our formulation development strategy based on in-depth study of patents, scientific literature, compendia information, critical quality attributes (CQA) and quality target product profiles (QTPP) of the respective drug delivery system and nature of the molecule.
We develop optimized processes that ensure smooth commercial manufacturing. We are sensitive in utilising the client investments/budgets to deliver a cost-effective solution for their formulation development needs. We help pharmaceutical companies to successfully resolve their challenging pharmaceutical compounds both in early-phase formulation development and as well as full generic development.
- Immediate Release
- Delayed Release
- Sustained Release
- Orally Disintegrating
- Parenteral Lyophilised powders
- Taste masked orodispersible/dispersible powder
- Effervescent granules
- Reconstitutable powders & granules (for sachets and bottles)
- Pellets (IR, ER and SR)
- FIH formulations – drug in capsule, powder blend/granules in capsules
- Modified release – beads or mini tablets in capsules