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Formulation development

Formulation evaluation

Evaluating prototype formulations is important in determining the most appropriate drug product formulation to align with the desired absorption profile in humans.

Corealis initiates formulation development projects by covering a wide range of formulations and manufacturing processes. These include: in vitro (e.g., dissolution profile, appearance, assays, related substances, crystal state, friability, hardness); and in vivo (PK results from an animal model) results. Corealis then selects the most appropriate drug product.

Corealis provides comprehensive formulation development services to bring clients’ innovations to the clinic quickly with phase-appropriate pharmaceutical oral solid dosage forms (e.g., tablets, capsules, pellets, granules) for:

  • New Active Pharmaceutical Ingredients (API)
  • Off patent APIs for 505(b)(2) filings.

The team offers development expertise for a diverse array of drug product formulations that are always adapted to the clinical phase, the therapeutic applications, and the targeted patient population:

  • API-in-a bottle, API-in-a-capsule
  • Immediate Release
  • Modified Release (e.g., delayed, sustained, multi-modal, gastro-retentive)
  • Sublingual
  • Bioavailability enhancement
  • Anti-drug abuse/alcohol dose dumping formulations
  • Effervescent
  • Powders, granules, and minitablets to be dissolved, suspended, or mixed in food substrates (e.g., apple sauce, yogurt)
  • Fixed dose combination of two to three APIs
  • Reformulation of drug products
  • Drug products for new therapeutic applications or different patient populations (e.g., pediatric, swallowing impairment)
  • Controlled substances
  • Highly potent API up to OEB 3
  • Matching placebos

The team utilizes small-scale, advanced equipment for efficient and scalable formulation and manufacturing processes:

  • Tabletting
  • Encapsulation (Pure API, powders, tablets, granules, multi-particulates and combinations)
  • Dry granulation (RC)
  • Wet granulation (FBG, high and low shear)
  • Amorphous enabling technologies (spray-drying (aqueous/solvents), coprecipitate dispersion, and hot melt extrusion)
  • Melt granulation
  • Extrusion and spheronization
  • Coating aesthetic or functional (FB and pan)
  • Packaging (bottle, blister, sachet) and labeling

Working with Corealis

Corealis experts will provide justification and recommendations to the client so that it can make the most informed decision for the next steps based on sound data.

A scientific and collaborative approach with clients helps develop the most appropriate drug product for the targeted therapeutic application from which product and manufacturing specifications are established.

With a team of experts, a collaborative approach, and a focus on efficiency, clients can trust Corealis as a reliable partner.