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Formulation Development : |
Services include drug delivery design,associated analytical method development/ validation, drug stability assessment. The facility provides documentation and regulatory support for NDA, ANDA, WHO, EU and other submissions integrating CTD design principles. |
| Profiling of API for development : |
Comprehensive testing consisting of chromatographic, spectral and differential scanning calorimetric techniques. |
| Pre-Formulation Studies : |
Development of suitable dosage forms to achieve enhanced solubility, sustained delivery, enhanced stability, targeted delivery, improved bioavailability, acceptability for specialized use.
IP circumventing options and IP generating options are proposed to clients which are integrated in the Product development plans. Some of the key attributes tested out during preformulation studies are: Solubility profile, Partition coefficient, pH rate profile,
Bulk density, Polymorphism, Particle size distribution, Flow properties, Stability, Dissolution, Drug-excipient inte |
| Product Development Plan : |
The product development plan is prepared to assist development of dosage forms and generally includes following information like Patent Information, Regulatory Information, Sourcing of API, Excipients & Packing Material, Analytical details, Innovator / Reference(Target) product evaluation, Design Input Specification for API, Excipients and for Product & timelines for the development activities.
The development of drug products follows the stages of labscale,scaleup and pilot batches of product with the detailed development report combined into a technical package available to clients. |
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