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.
A wide range of pharmaceutical formulation development capabilities
Our development capabilities for oral dosage forms include:
- Immediate and modified release tablet and capsule formulations
- Other solid oral doses, including granules, orally disintegrating and multilayer tablets, liquid and semi-solid filled capsules
- Oral multiparticulates, such as beads, pellets and mini tablets
- Oral liquids and suspensions, and powders for reconstitution
- Liquids for nasal delivery
- Topical products, such as semi-solid products (creams, gels, lotions)
- Parenteral delivery, including IM, SC, IP and IV products
Why SGS?
We are the world’s leading testing, inspection and certification company, recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.
