Our scientists offer outstanding expertise in all areas of pharmaceutical formulation development, including cutting-edge knowledge to develop and optimize exotic controlled release, microemulsion, microsphere, liposome, and targeted delivery dosage forms.
KPPT's formulation experts have an excellent track record of successful formulation development, including troubleshooting difficult problems other scientists may be unable to handle. Our goal is to give your product the state-of-the-art efficiency and effectiveness required in today's competitive market.
Solid Dosage Form Development
Appropriate excipients, drug-excipient ratios, and process steps are established for the preparation of immediate, controlled, and sustained release tablets and capsule dosage forms. Analytical methods for content uniformity, weight variation, disintegration, dissolution, and stability testing are fully developed and validated so clinical production and technology transfer for scale-up to commercial production can occur rapidly and efficiently.
Immediate Release Tablets
Direct compression and wet/dry granulation formulations optimized for rapid dissolution and content uniformity.
Controlled Release Systems
Matrix, reservoir, and osmotic pump designs for extended release profiles tailored to the therapeutic window.
Capsule Formulations
Hard gelatin capsule filling including powder blends, pellets, and liquid-in-capsule systems.
Enteric & Specialty Coatings
Film coating development including enteric coatings, moisture barriers, and controlled release barrier coatings.
Parenteral Dosage Form Development
Appropriate excipients, drug-excipient ratios, solvents, and compounding procedures are established for the preparation of liquid and lyophilized dosage forms. Container/closure, filter, and process equipment compatibility studies can be performed. Studies are performed to evaluate the acceptability of moist heat terminal sterilization.
Lyophilization cycles, cleaning methods, and all aspects of the parenteral dosage form process are comprehensively developed and optimized so clinical production and technology transfer for scale-up to commercial production can occur rapidly and efficiently.
Specialized & Novel Drug Delivery Systems
KPPT has particular strength in novel and complex formulation platforms that require specialized know-how:
Our Development Process
Preformulation Review
Leverage API physicochemical data to define formulation strategy, target product profile, and critical quality attributes.
Prototype Development
Design and prepare candidate formulations using DoE-driven approaches to efficiently explore the formulation space.
Optimization & Scale-Up
Refine the lead formulation and transfer to pilot/clinical scale with process validation protocols in place.
Analytical Method Development
Develop and validate stability-indicating methods per ICH Q2(R1) guidelines ready for regulatory submission.
Regulatory Documentation
Prepare CMC sections for IND, NDA, and ANDA submissions with full batch records and specification documentation.
From Lab to Commercial — All In-House
KPPT is one of the very few cGMP CDMOs that can take your formulation from early development through commercial supply without outsourcing any step. This continuity ensures quality, speed, and cost-efficiency at every stage of your program.