Pharmaceutical Formulation Development

Pharmaceutical development and dosage form optimization for a wide range of product types, including those that have poor solubility or bioavailability.

Effective formulation provides the best chance of clinical success during the development of any new drug product. We provide a wide range of services tailored to your requirements and the objectives of your active pharmaceutical ingredient (API). Our services can support drug product development activities including:

• Evaluation in First in Human (FIH) studies
• Establishment of Bioequivalence against a well-established product
• Specific in vivo targeting to achieve a specific pharmacokinetic profile
• Circumvention of existing intellectual property

Why choose drug product development from SGS?

We enable you to:

• Benefit from a global network of pharmaceutical formulation experts
• Access the latest technologies and state-of-the-art testing facilities
• Obtain extensive formulation support
• Develop formulations, designed to match your requirements and resources
• Get a formulation development strategy to bring your drug to clinical evaluation rapidly and effectively

Formulation development strategy

We investigate the fundamental properties of a drug and prepare a formulation development strategy to allow a focused and efficient pathway to clinical evaluation.

With a first-principles approach to drug product development, we aim to understand the physicochemical properties of your API and the challenges associated with the disease state intended for treatment.  We work with you to establish clear target product profiles (TPP’s) at project concept.

Each project is tailored specifically to your exact needs, including service schedule, agreed risk and target timelines. A typical project outline may include:

• Physicochemical assessment of API and gap analysis
• Preformation studies
• Prototype development – dosage form studies and analytical method validation

Proven experience with the development of over 350 formulated drug products

We have provided dosage form design and development services since 2002 to support the development of over 350 formulated drug products through the many stages of clinical development. This includes supporting a number of products to successful marketing authorization.

Our experience spans the delivery of small molecules, large molecules (such as oral domain antibodies), live biotherapeutics (including anaerobic bacterial strains, phage and extracellular vesicles) and controlled drugs. Some of the disease states our formulations have targeted include: oncology, dementia, diabetes, heart disease and immunological and various pediatric conditions.

A comprehensive range of technology and process options

Our work is carried out on a purely fee-for-service basis, without the use of ‘platform technologies’ to ensure the best formulation development and the best chance of clinical success. Our capabilities enable us to use the following technologies/processes to establish the most suitable formulations for delivery:

• Lipid-based approaches
• Spray drying
• Lyophillisation
• Drug layering
• Wet and dry granulation
• Nanomilling
• Aqueous and solvent based coating processes

Wherever you operate in the world, we support you at every step of your product’s development with expert formulation development support that ensures you deliver safe, effective and compliant products to global markets.

To discuss your drug formulation development requirements, contact us today.