Deformulation and Formulation of Multi-Component, Controlled Substance, Sustained Release Product for ANDA Submission and Commercialization
Benefits of Case:
- Deformulation and Formulation of 3 different strengths of a combination sustained release generic oral solid dosage form
- Progress client to ANDA submission with acceptable dosage forms
Background and Challenge:
The Client wanted a sustained release product deformulated and reformulated. The drug product contained two APIs which were both class II controlled substances in 3 different strengths. The new formulation could not infringe upon existing formulation patents covering a variety of methods to stabilize the drugs in the solid dose form.
CoreRx™ Development Strategy:
Tailor multidisciplinary team of formulation development, analytical chemistry and manufacturing to identify possible approaches for formulation development.
- Execute experiments to understand the formulation of the Reference Listed Drug (RLD), and explore possible formulations
- Review patent literature on the protected technologies used to stabilize the drug substance in the dosage form and determine which formulation approaches that permitted “freedom to operate”
- Identify a stable formulation and manufacture batches to support an ANDA filing
The Objectives:
- Rapidly determine the qualitative and quantitative formulation of the RLD
- Identify approaches for a stable formulation with “freedom to operate”
- Complete formulation work without disruption to the proposed ANDA submission schedule
Value for the Client:
CoreRx™ staff identified a stable formulation that met the client’s needs for planned ANDA submission and intellectual property requirements within 3 months.
Results from CoreRx™ Combined Experience and Expertise:
CoreRx™ quickly assembled a team with expertise in formulations, analytical chemistry, organic chemistry, patents, and manufacturing to perform a thorough analysis of the RLD and determine a new sustained release formulation without infringing on existing patents. To quickly evaluate potential solutions to the stability problem, numerous experiments evaluating alternative formulation and packaging approaches were designed and performed. Once formulations were narrowed down, stability batches were made to identify the formula that would solve the stability problem and allow the development of the ANDA to meet the client’s previously established schedule.
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