@jauhar123 | Posted 12 Jun. 2019
Formulation development studies define the optimal dosage form, composition, and manufacturing route is a fundamental component of pharmaceutical product development. Getting pharmaceutical formulation development right benefits to optimize drug delivery performance and product durability. Compact dosage forms, in particular, smelled and nasal products can present unique challenges for managing the performance of the drug product and influence bioavailability. At GVK BIO, this can recognize the significance of our clients’ requirement to develop robust and compliant formulations.
The Formulation Development Companies concentrate on both generic as well as NCE formulations, which fulfill administrative requirements
of targeted markets, possess attributes investigated after by medical practitioners and meet customer’s performance metrics.
Some companies have the right equipment, abilities, and highly dedicated formulation development experts to help you arrive at the optimal dosage form for your API and purpose. They ensure any ways to produce are scalable, compliant, and commercialize for clients. They also adopt a comprehensive, time-bound strategy in promoting stable products that are efficient in all quality aspects. The formulation development team enables small quantities of drug product materials to be developed using experimental design methodologies established by testing at every stage with key performance analytics including solubility, release, solid-state characterization and powder and particle morphology investigations.
The formulation development strategy is based on in-depth study of limitations, scientific literature, compendia information, critical quality attributes (CQA) and quality target product profiles (QTPP) of the particular drug delivery system and nature of the molecule.
It also develops optimized methods that ensure smooth commercial manufacturing. They are sensitive in using the client investments/budgets to deliver a cost-effective clarification for their formulation development needs. We help pharmaceutical companies to actively resolve their challenging pharmaceutical compounds both in early-phase formulation development and as well as full general development.
Fluid Bed Processor (drug loading, granulation, and drying)
Fluid Bed Dryer – various drying chambers (10g to 1.5kg)
Tablet Compression Machine with B, D & BB tooling
Tablet Coating Machine with different pan sizes (30g to 1kg)
Extruder Spheronizer – proper to handle low NCE quantities
Multiprocessor for ***** fluids, solids, and semi-solids
Moist temperature sterilizer
Dry warmth sterilizer
Homogeniser (suspensions and emulsions)
Blister filling machine
Flow analysis apparatus
Capsule filling device
The developing of a robust and cost-effective production process for smooth scale-up or commercialization. The selection of ingredients and process assures production of cost-effective quality products.
The Process Development (PD) strategy presents a promising process for converting a drug from development laboratories into an efficient drug delivery system. It develops manufacturing processes for an extremely low percentage of APIs in tablets and capsules. Also, the experience involves improvement of flow properties of low bulk density substance that yields trouble free product on the shop floor. The scientists are well-versed in developing processes for composite formulations and innovative technologies such as enteric-coated capsules multi-layered pellets, nano-suspension, and micro-tablets.