OVERVIEW
Pre Formulation Development
Solubility Enhancement
Taste Masking Strategies
High Potenct Formulations
Pediatric Formulations
Solubility Enhancement
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
- BioDuro-Sundia’s Solubility Enhancement is the fastest & most effective path to clinical formulation. We combine computer modeling, in-vitro screening & in-vivo PK to deliver optimal Amorphous Solid Dispersion prototypes. With 50-100mg of API & 8-10 weeks, we provide with reliable protoypes to use in Phase I formulation & dosage development.
BioDuro-Sundia Advantage
- Reliable prototypes to use in Phase I formulation & dosage development.
- Data-driven excipient miscibility prediction
- Rational selection of polymers
- Amorphous Solid Dispersion prototype screen
- 2 rounds of mouse PK
Features
- Fast Path to Optimized Clinical Formulation
- Predictive computer aided thermodynamic polymer screen modeling used to select matrices for development of Amorphous Solid Dispersion (ASD) or Lipid Based Drug Delivery systems.
- High Throughput Screening: 100s of matrices evaluated in just weeks.
- In-vivo Validation: Rapid in-vivo PK evaluation to optimize clinical formulation.
- Maximized Availability
- Optimize bioavailability with rank order matrices.
- Solve solubility & controlled release questions.
- In-vitro & in-vivo correlation of API characteristics.
- Optimized PK Profile
- Coated mini tablets for oral controlled release (enteric, SR, enteric/SR, timed release, colonic delivery) for rodent (mouse or rat) studies.
- Oral SR matrices for rodent (mouse or rat) studies.
- Injectable & implantable SR micro-particles & implant for rodent (mouse or rat) studies.
- ASD Prototype in 10 weeks
- Week 1: Start your study immediately after initial discussion.
- Week 3 - 6: Complete matrix screening & generate first in-vivo PK data set.
- Week 7 – 10 : Optimized prototype & generate final in-vivo PK data set.
Service Areas
- Amorphous Solid Dispersion Development
- Micronization
- Nano-suspensions
- SEDDS/SMEDDS
- Evaluation at Lead Selection / Early Tox stage