OVERVIEW
Pre Formulation Development
Solubility Enhancement
Taste Masking Strategies
High Potenct Formulations
Pediatric Formulations
Pre-Formulation Development
Data driven decision making coupled with years of formulation expertise for meeting therapeutic and delivery needs to deliver API to its target. A measured balance between innovation and pragmatism has allowed Formulations at BioDuro-Sundia to thrive as a unit capable of developing novel solutions & implementing them on time to predetermined specifications.
Overview
- Through "One-Stop Shop" formulation and product development platform, our team works seamlessly with the Process Development, Analytical and DMPK teams to help accelerate your drug candidates quickly from the pre-clinical stage to IND/NDA/ANDA filings.Chemical, physical, and biological characterization of drug candidates that that will help drive the seamless decision making around formulation development. BioDuro-Sundia’s pre-formulation solutions incorporate chemical and physical characterization with biological characterization such as Caco-2 permeability and small animal DMPK. Supported by integrated project management, BioDuro-Sundia’s extensive pre-formulation program elucidates candidate attributes to drive decision making in formulation development, helping predict the best formulation approach.
BioDuro-Sundia Advantage
- Seamless integration across cross functional teams.
- Proven track record
- Cost-effective & high quality
- Integration with PK studies
- Enabling data-driven drug development using milligrams of API
Service Areas
- Pre-formulation & Discovery Support
- Solubility, stability, compatibility, logP testing.
- Solid form screening & selection
- Physicochemical profiling, drug ability assessment
- Formulation & Process Development
- Process development based on physicochemical and physical properties of drug candidates.
- Storage and shipping conditions assessment of drug candidates
- Technology transfer of formulation and manufacturing process to clinical manufacturing sites
- CMC document preparation for IND/NDA/ANDA submission
- Filing Document Preparation
- CMC document preparation and regulatory support
- CFDA/FDA/EMA/TFDA dossier filling support.
- Pre-formulation Development
- pH/Aqueous Solubility
- Solid state characterization
- Intrinsic Properties Profiling & Dissolution
- Polymorph screening
- Salt screening
- Co-crystal Screening
- Crystallization Process