Our formulation development services capabilities
- Immediate, orally disintegrating, modified, delayed, extended release and controlled-release tablets and capsules
- Over-encapsulation for double-blind studies
- Bioavailability enhancement
- Highly-potent compounds
- DEA controlled substances (Schedule I-V)
- Combination of multiple APIs
- Matching placebo (solid, semi-solid and liquid dosage form)
- Powder/blend filling in bottles, vials and pouches using automatic filling machine
- Drug layering and particle coating (Wurster column and top spray coating processes)
- Liquid in hard gel capsule and banding/sealing
- Solution, suspension, powder for reconstitution
- Tablet, capsule and pellet coating
- Semi-solid and topical formulation development
Our formulation development services and analytical testing capabilities can prepare your innovations for Phase I in as little as four weeks. We know what it takes to get your product into clinical trials, evaluating critical quality attributes (CQAs) from R&D to GMP manufacturing.
We treat your formulation as our own, working closely with you to overcome challenges and optimize your product for a wide range of dosage forms. Our time-tested approach has flexibility built in, backed up by our robust quality-by-design framework, to maximize efficiency and minimize risk.
With Sharp, you get a partnership shaped around you. We are committed to protecting your innovation and supporting you to the next stop on your journey, clinical trials.
Our analytical and research & development teams use advanced investigative technologies to provide clients with the innovation required to move a product from clinical development to commercialization and ultimately to patients.
Pre-Formulation Services
- Excipient-API compatibility studies
- Formulation evaluation using accelerated/stress conditions (e.g. 40°C/75%RH, 50°C)
- Hygroscopicity studies
- Photostability
- Prototype evaluations
- Reverse engineering
Formulation Development Services
- Early to late phase formulation development and reformulations
- Determine blending times for tableting, encapsulation and analysis of characteristics (blending time, bulk density, content uniformity and flow characteristics)
- Over-encapsulation and comparator product blinding
- Developing matching placebo products and comparator supplies
- Developing both ethical and over-the-counter (OTC) products, including tablets (immediate and controlled release), powders, liquids, suspensions, emulsions, creams, ointments and lotions
- Developing line extensions in the above dosage forms
Technical Capabilities
- Immediate, orally disintegrating, modified, delayed, extended release and controlled-release tablets and capsules
- Over-encapsulation for double-blind studies
- Bioavailability enhancement
- Highly-potent compounds
- DEA controlled substances (Schedule I-V)
- Combination of multiple APIs
- Matching placebo (solid, semi-solid and liquid dosage form)
- Powder/blend filling in bottles, vials and pouches using automatic filling machine
- Drug layering and particle coating (Wurster column and top spray coating processes)
- Liquid in hard gel capsule and banding/sealing
- Solution, suspension, powder for reconstitution
- Tablet, capsule and pellet coating
- Semi-solid and topical formulation development
Technical/Analytical Services
- Evaluating commercial products for use in clinical trials and comparative studies
- Formulation optimization and evaluation of excipients for use
- Technical transfer from R&D to clinical production facilities
- Process optimization
- Scale-up and assessment of current products
- Blend and content uniformity evaluation
- Dissolution testing
- Stability assessment
- In-vitro dissolution profile evaluation
- Powder flow determination
- Tablet compressibility evaluation
- Disintegration testing
- Friability testing
- Tap density testing
- Particle size testing
