Formulation Development

Formulation Development

Kemwell has expertise developing drug formulations for conventional and specialized dosage forms, including solids, liquids, semi-solids, and injectables. We understand the importance of delivering a quality, stable formulation, on time and on budget.

  • Formulation development (clinical to commercial)
  • Drug prototype development
  • Process Optimization and Scale-up
  • Comparator product modification for blinding studies
  • Lab & pilot scale manufacture
  • Registration batch manufacture
  • cGMP clinical manufacture for Phase I – IV clinical trials supplies & placebo
  • Clinical packaging & labeling
  • Technology transfer

Kemwell’s Pharmaceutical Development labs in India are led by a strong management team with the necessary experience, scientific knowledge, vision and steadfast commitment to meet each customer’s needs.

Formulations are rationally developed to enhance product stability, bioavailability, patient compliance, and ultimately the customer’s expectations. Additionally, Kemwell has extensive expertise in Quality by Design (QBD), and can incorporate it in your formulation program.

Our scientists approach each formulation project with the commercial product in mind. We integrate process development and scale-up in the process at early stages, minimizing the potential for costly reformulation down the road. Each formulation program will include the development of multiple drug product prototypes. These prototypes are subsequently subjected to demanding conditions, chemical and physical testing, ultimately producing an ideal drug formulation for our customer.

Planning and preparation

Prior to prototype development exhaustive pre-formulation studies are performed. Characterization of the Active Pharmaceutical Ingredient (API) is critical to defining a successful formulation approach. Proper drug substance evaluation at the pre-formulation stage can minimize potential formulation, manufacturing, scale up, and instability issues.

Drug stability profiling during pre-formulation & formulation development, including GRAS excipient compatibility can provide innovative solutions to drug product instabilities and product specifications. At Kemwell, our focus is to deliver a product formulation that is stable when exposed to forces such as temperature, light, and humidity.

We work with you

At Kemwell, we work with each client to understand the corporate goals, marketing goals, timing, and budget expectations. Kemwell takes a collaborative approach to Drug Formulation Development, utilizing product API characteristics (stability, physical properties), to meet the customer product specifications and clinical needs. Evaluating dosage and delivery options during the early stages of development help ensure that the final product will meet the clinical, regulatory, and patient needs.

Quality by Design (QBD) Program
  • Define Target Product Profile (TPP)
  • Critical Quality Attributes (CQAs) determined
  • Risk assessment: Link material attributes and process parameters to CQAs
  • Identify Design space using DoE
  • Control strategy for sensitive products (moisture/oxidation)
  • Product life cycle management & continual improvement
Dosage Forms
  • Oral
    1. Capsules
    2. Tablets (coated & uncoated)
    3. Effervescent tablets and powders
    4. Orally Disintegrating Tablets (ODT)
    5. Granules and Powders
  • Liquids
    1. Solutions
    2. Suspensions
    3. Syrups
  • Parenteral (small and large molecules)
    1. Solutions (vials and pre-filled syringes)
    2. Lyophilized (vials)
    3. Suspensions
    4. Emulsions
    5. Liposomes
  • Semi-solids (sterile and non-sterile)
    1. Ointments
    2. Gels
    3. Creams
    4. Suppositories
  • First-in-human formulations
    1. API in Capsule
    2. API in Bottle
    3. Powder in Bottle
    4. Formulated Product
  • Poor solubility & bioavailability
  • Formulation optimization
  • Generic formulation development
  • OTC formulation development
  • NCE formulation development
  • Pediatric & geriatric formulations
  • Sustained release, pulse, and modified release
  • Utilize safe raw materials (GRAS)