Formulation Development

Our formulation development scientists 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.

We adopt a comprehensive, time-bound strategy in developing stable products that are efficient in all quality aspects. We work on our 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 optimised 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.

We assist with following dosage forms:

Tablets

  • Immediate Release
  • Delayed Release
  • Sustained Release
  • Orally Disintegrating
  • Bi-layered
  • Chewable

Powders

  • Parenteral Lyophilised powders
  • Taste masked orodispersible/dispersible powder
  • Effervescent granules
  • Reconstitutable powders & granules (for sachets and bottles)

Capsules

  • Powder/granules
  • Pellets (IR, ER and SR)
  • FIH formulations – drug in capsule, powder blend/granules in capsules
  • Modified release – beads or mini tablets in capsules

Semi Solids

  • Gels
  • Creams
  • Ointments

Injectables

  • Solutions
  • Suspensions
  • Emulsions

Ophthalmics

  • Solutions
  • Ointments
  • Suspensions
  • Gels

Formulation Infrastructure & Equipment

  • Fluid Bed Processor (granulation, drug loading and drying)
  • Fluid Bed Dryer – multiple drying chambers (10g to 1.5kg)
  • Tablet Compression Machine with D, B & BB tooling
  • Tablet Coating Machine with multiple pan sizes (30g to 1kg)
  • Extruder Spheronizer – suitable to handle low NCE quantities
  • Multiprocessor for oral liquids, solids and semi solids
  • Moist heat steriliser
  • Dry heat steriliser
  • Homogeniser (suspensions and emulsions)
  • Blister packing machine
  • Flow test apparatus
  • Capsule filling machine

Process Development

We develop a robust and cost-effective manufacturing process for smooth scale-up or commercialisation. Our selection of ingredients and process ensures production of cost effective quality products.

Our Process Development (PD) strategy provides a promising process for converting a drug from discovery laboratories into an efficient drug delivery system. We develop manufacturing processes for very low percentage of APIs in tablets and capsules. In addition, our experience involves improvement of flow properties of low bulk density material that yields trouble free product on the shop floor. Our scientists are well-versed in developing processes for complex formulations and innovative technologies such as enteric-coated capsules, nano-suspensions, multi-layered pellets and micro-tablets.

Technology Transfer & Process Validation

All technology transfer activities performed by GVK BIO for its clients are based on sound principles of project management. We consider every technology transfer assignment as an important task to be accomplished. A dedicated Task Force Team (TFT) comprising of professionals from different functions combine their knowledge and expertise ensuring successful technology transfer.

Technology transfer goes through the following stages:

Planning
The TFT pools in its expertise to formulate a detailed plan considering the dosage form and the regulatory requirements specific to the technology transfer. The plan called Technology Transfer Protocol outlines the responsibility of different functions and deliverables of members of TFT with target dates. A detailed process evaluation protocol will be prepared in consultation with the client. This will be implemented to understand critical attributes of the technology taken for transfer.

Execution
The TFT works in tandem to ensure efficient implementation of technology transfer protocol. We execute the process evaluation protocol simultaneously with the manufacturing activity. The team has been trained to follow the best practices, following all the required SOPs, batch records, quality systems and regulatory requirements. The observations and stage-wise results are recorded concurrently. We endeavour to address any deviations or processing problems observed during technology transfer.

Report Writing
A detailed technology transfer report prepared by the TFT and reviewed by the senior team will be provided to the client. The report comprises of a list of critical attributes with measurable performance indicators for trouble free manufacturing of the product in future.

Process Validation

Our scientific team is experienced in scaling up from R&D batches to commercial batches. In addition, our expertise includes scaling batch sizes up to 1,000 kilograms in state-of-the-art facilities. Our team is experienced in execution of process validation batches as per world-wide regulatory requirements.

Reformulation Development

GVK BIO is flexible in accommodating its valuable scientific resources and facilities to serve its customers through short term projects that are highly specific but critical for new product registrations or upgradations of existing products. We call this segment of our services as Customised Formulation Research Projects as we arrive at project scope only after thorough discussions with the customers.

Also, we present our approach to the customer and classify into any of the following but not restricted to:

  • Improvement of Bioavailability
  • Improvement of stability
  • Improvement of drug release
  • Formulation and process optimisation
  • Cost reduction
  • Compliance to upgraded regulatory requirement

We reformulate with better understanding of retrospective data by application of scientific excellence and past knowledge. Our scientists are capable of proposing competent strategies and effectively implement them to resolve the challenges in formulations for different business partners. We consider the evolving regulatory guidelines including SUPAC/similar ones while reformulating the product.

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