Pre-formulation Capabilities Analysis Services

Creative Biolabs is a leading company in pharmacy with a multidisciplinary, qualified & experienced team. We can apply our considerable experience with drug properties to develop a specific solution for your pre-formulation analysis.

Before a potential active pharmaceutical ingredient (API) or drug can be successfully put into a dosage form for clinical trials and licensing, we must clearly understand its characteristics and behavior in the environment in which it will be stored, as well as its behavior when exposed to the human body.

Introduction of Pre-formulation

Pre-formulation is a branch of pharmacy, which uses biopharmaceutical principles to determine the physical and chemical properties of API. The goal of the pre-formulation study is to select the correct form of the drug substance, evaluate its physical properties, and have a comprehensive understanding of the stability of the material under various conditions, so as to obtain the best drug delivery system.

Pre-formulation studies are an important tool early in the development of both API and drug products. The overall objective of pre-formulation testing is to generate information useful to the formulator in developing stable and bioavailable dosage forms that can be mass-produced.

Early-stage pre-formulation studies. Fig.1 Early-stage pre-formulation studies. (Trevor, 2018)

Significance of Pre-formulation

Thorough pre-formulation evaluation provides a basis for the development of robust dosage forms capable of maintaining integrity during manufacturing, shelf life, and in vivo delivery. In the long term, taking enough time for a comprehensive pre-formulation evaluation may reduce the challenges during formulation development and thus result in cost savings.

Pre-formulation studies at various stages of development. Fig.2 Pre-formulation studies at various stages of development. (Trevor, 2018)

Pre-formulation Analysis Services at Creative Biolabs

  • Organoleptic properties (including color, odor, and taste)
  • API stability analysis
  • Including the chemical integrity, labeled potency, appearance, palatability, uniformity, dissolution, and suspendability that should be maintained during the shelf life of the product.

  • Excipient compatibility
  • To identify, quantify and predict potential interactions (physical or chemical) along with the impact of these interactions on the manufacturability, quality, and performance of the final drug product.

  • In vitro diffusion studies using Franz diffusion cell.
  • Specific gravity testing.
  • Informal stability/formulation stress testing (both physical and chemical).
  • Formulation and packaging compatibility studies.
  • Compatibility studies must be included in the dossier submitted for a marketing authorization whenever a new product is introduced or when an after post-approval variation related to a material change occurs.

  • Tablet compaction analysis.
  • Supply of liquids, mini-capsules, and mini-tablets for use in animal studies.

The knowledge of drug properties determines the appropriate formulation and delivery method for Pre-Clinical and Phase 1 studies. Creative Biolabs has highly qualified and experienced technical staff in pre-formulation. A wealthy knowledge of your drug properties will accelerate your drug development in later stages. Please contact us for our pre-formulation capabilities analysis services, which can effectively reduce drug development costs and shorten your time to market.

Reference

  1. Trevor, M.J. CHAPTER 1:Preformulation Studies, in Pharmaceutical Formulation: The Science and Technology of Dosage Forms. 2018, pp. 1-41.

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