Preformulation and Formulation

Capsugel provides integrated product development services to its biopharmaceutical clients using a broad range of key technologies to tackle formulation challenges. By co-locating product design, development and manufacturing operations at the same sites in the United States and Europe, we ensure rapid development through clinical studies and commercialization, as well as efficient technical transfer of innovative products.

We provide a full range of development services, including analytical method development and stability testing. Specialized capabilities are in place to handle controlled substances, hormones and high-potency drug compounds.

Pre-formulation

Capsugel’s integrated product development sites provide rapid pre-formulation screening to assess and characterize APIs and excipients. We focus on fully evaluating the physical and chemical properties of each compound and its dosage form requirements to develop tailored problem statements and guide preliminary formulation decisions. Physical and chemical characterizations provide our product development teams with critical information about the properties of the compound and the most desirable enabling technologies and formulation approaches. 

Capsugel enables rapid compound feasibility assessments with micro-dosing services for powder-in-capsule (PIC) studies. Capsugel Xcelodose® Precision Powder Micro-Dosing Systems are used for precise PIC micro-dosing of capsules for pre-clinical and Phase I-II studies. Our product development teams have extensive experience with PIC studies, having produced more than 200 compounds and over 600 batches that have been shown to significantly reduce drug development time by avoiding excipient compatibility studies in early assessments. 

Specialized clinical capsules have also been developed to further assist customers with their pre-clinical and clinical studies. PCcaps® Capsules offer a simple approach to pre-clinical oral administration of pharmaceutical actives and formulations to rodents. DBcaps® Capsules can readily be used to blind your test compounds. All Color Capsules provide flexibility in capsule color decisions later in product development without incurring costly delays.

Intrinsically enteric capsule technologies (Vcaps® Enteric and enTRinsic Drug Delivery Technology) allow for rapid proof-of-concept screening of compounds that require enteric protection or delayed release. By avoiding the use of functional coatings, significant time-savings can be realized in pre-clinical and clinical studies.

Formulation Development

Formulations are developed based on pre-formulation assessments of compound properties, problem statement definitions, and excipient compatibility studies. We have extensive formulation experience and expertise across a full range of enabling technologies and solid oral dosage forms: 

  • Micronized / nano-milled compounds
  • Drug Product Intermediates – spray-dried dispersions, multiparticulates
  • Specialized Tablets – osmotics, bi- and tri-layer matrices, orally dissolving, mini-tabs
  • Capsule or Sachet-Based Formulations – powders, granules, multiparticulates
  • Liquid-Filled Hard Capsules – lipid / solvent / co-solvent based formulations including SEDDS, SMEDDS
  • Soft Gelatin Capsules – lipid / semi-solid based formulations

We also develop formulations for inhalation drug delivery using our spray-dried particle engineering expertise.

Integrated Product Development Sites

Capsugel’s integrated product development sites are equipped with a full range of formulation development and process analytical capabilities, including:

  • Advanced imaging systems, including electron microscopy
  • Materials characterization technologies, including nuclear magnetic resonance spectroscopy
  • Advanced surface characterization techniques, including thermal analysis and particle sizing

Fully equipped pilot plants for formulation development include the equipment needed for proof-of-concept assessments through clinical trial manufacture for a full range of oral solid dosage forms.