Tablets
- Experience on developing generic and first to file tablets dosage form.
- Worked on variety of tablets i.e Immediate release, Delayed release, Bilayer modified release, MUPS tablets, Sustained release, Extended release, Gastro retention tablets, Effervescent tablets, chewable tablets and Potent tablets.
- Hands on experience in handling low doses like, 0.0625 mg, 0.125 mg, 0.240 mg,0.2 mg, 0.4 mg, 0.5 mg, 1 mg etc.
- Experience on various technologies like, wet granulation, dry granulation, direct compression process, top spray granulation, wuster coating, usage of low humidity area, API coating, taste masking, etc have been used in development of different dosage forms.
- Successfully developed first to file extended release tablet dosage form for US market.
- Successfully developed and tech transferred bilayer modified release tablets project for Australia market
- Successfully developed and tech transferred effervervescent tablets for regulated markets.
- Successfully developed a 19 active containing multivitamin and multimineral tablets dosage form for regulated market
Capsules
- Experience in development and scale up of dose weight proportionate and look alike
multiple strength formulation, Drug loaded pellets, extended release pellets based capsules and soft gel capsules. - Successfully developed 7 strengths look alike and dose weight proportionate formulation for china market
- Successfully developed extended release pellets formulation, including API pelletization followed by polymer coating to achieve desired release profile
- Successfully completed development and technology transfer of antibiotic capsules dosage form having formulation challenges
Liquid Oral
- Developed multiple liquid products i.e syrups, suspension, powder for oral suspension, oral solutions for different regulated markets.
- Successfully developed and technology transferred multiple antibiotic powder for oral
suspension projects - Successfully developed and technology transferred suspension products to Australian, US and Chinese manufacturing sites
505(b)(2)
Establishing a strong Pharmacokinetic (PK) Development Plan – one that minimizes risk, maximizes value, and is both understandable and agreeable to FDA at program initiation.
Specific examples that often benefit from a strong PK development plan include:
- Altering the release kinetics of the existing formulation
- Changing the route of administration
- Finding a new indication
- Altering the dose on the basis of the existing drug’s pharmacokinetic (PK) and pharmacodynamics (PD) profile
- Combining drugs to enhance efficacy and/or improve safety
Few examples are as follows:
- Successfully completed projects where immediate release tablet converted to a gastric retention tablets. Product has promising BE data compared to reference. Developed dosage form will reduce the number of doses to be taken compared to the reference.
- Successfully completed projects where in immediate release tablets converted to stable liquid oral solution. The developed product has help reduce fluctuation of drug concentration in the blood thereby reducing variability and adverse effects. Product found bioequivalent with reference.
Ophthalmic
- Hands on experience in developing ophthalmic dosage forms.
- Establishing Q1 and Q2 of the formulation, through controlled correspondence with the agency and starting the development
- Development and technology transfer to selected CMO
- Establishing the Extractable and leachable studies
Injectable
- Injectable dosage form facility available
- Capability of developing injectable formulations like ; solutions, suspensions etc.
- Development and technology transfer to selected CMO
- With support of establishing Extractable and leachables
