Pharmaceutical Formulation Development

Why Pharmaceutical Formulation Development Matters?

Pharmaceutical formulation development is a key process in drug development, which ensures that active ingredients that exert pharmacological effects are provided to patients in the form of stable pharmaceutical preparations. Typical pharmaceutical dosage forms include oral tablets, capsules, solutions, suspensions, topical ointments, gels and solutions, injectables, and products for transdermal and inhalation. All of these formulas must be blended with certain inactive ingredients to ensure proper release and absorption of the active ingredients. For example, common inactive ingredients in tablet formulations include binders, disintegrants, diluents, lubricants, glidants, colorants, and other specialized ingredients that can alter drug release or enhance absorption. Inactive ingredients used in semi-solid formulations may include water, oils, surfactants, emulsifiers, stabilizers, preservatives, and pH adjusters. In comparison, injectable formulations use smaller amounts of inactive ingredients due to strict requirements, including water, isotonic regulators, cosolvents, and pH adjusters (if necessary). Due to the complexity of various ingredients, pharmaceutical formulation development requires a variety of different technologies and considers many factors, including the physical and chemical properties of the drug, bioavailability, pharmacological activity, solubility, and bioavailability, etc., to overcome various complex challenges.

Explore Our Pharmaceutical Formulation Development Services

CD Formulation provides formulation discovery and development services for various preparation types, from pre-formulation research, formulation design, drug delivery system evaluation, process scale-up production, and clinical trial drug production. Our expert team is composed of medicinal chemists, biochemists, pharmaceutical formulation experts and highly qualified laboratory personnel with decades of development experience in the pharmaceutical industry, who are committed to providing customers with high-quality formulation solutions.

We can customize the formulation that best suits our customers' products according to their specific needs, and conduct continuous communication and cooperation throughout the development process. Our service scope covers various types of pharmaceutical formulations, including solid preparations, liquid preparations, semi-solid preparations, etc. We also provide customized drug delivery system evaluation services to help customers choose the most suitable delivery system for their drugs to achieve the best therapeutic effect. 

The following are areas of focus for our pharmaceutical formulation development, including but not limited to:

General Workflow of Our Pharmaceutical Formulation Development

• Understand the physicochemical properties of the active pharmaceutical ingredient (API) to determine the best formulation approach.
• Conduct preformulation studies to assess the compatibility of the API with different excipients and determine the solubility, stability, and bioavailability of the drug.
• Select appropriate excipients that are compatible with the API and have desirable properties to optimize the formulation.
• Develop a formulation that balances the desired drug release profile, stability, and patient compliance.
• Consider factors such as route of administration, dosage form, and release mechanisms when developing the formulation.
• Conduct stability studies to assess the long-term stability of the formulation under different storage conditions.
• Test the formulation for bioavailability, pharmacokinetics, and pharmacodynamics to ensure it meets the desired therapeutic outcome.
• Optimize the formulation based on the results of in vitro and in vivo studies to improve efficacy and safety.
• Conduct formulation scale-up and manufacturing process optimization to ensure consistent product quality and performance.

What Problem Can We Solve?

• Pharmaceutical formulation development for new chemical entities (NCEs).
• Optimization of existing pharmaceutical formulation.
• Screening and compatibility of excipients.
• Feasibility analysis for pharmaceutical formulation development.
• Physical and chemical analysis of API, excipients, and pharmaceutical formulation.
• Pilot scale-up.

Why Choose CD Formulation for Pharmaceutical Formulation Development?

• Extensive expertise in formulation development across multiple formulation types (oral liquids, extended-release tablets/capsules, nanoemulsions, multidrug combinations, complex injectables).
• End-to-end capabilities, from pre-formulation research to production of clinical trial drugs.
• Extensive services, from pre-formulation design and development of new drugs to formulation modification of existing drugs.
• One-stop CMC analysis capabilities provide support for the development of optimized formulations.
• Analytical laboratories that comply with regulatory requirements.
• Robust manufacturing processes, including conducting manufacturing scale-ups and registering batches.

CD Formulation's pharmaceutical formulation development will be customized based on your specific pharmaceutical APIs and target product profile (TPP). Please contact us today for your exclusive solution.