Formulation Development

* Please kindly note that our products and services can only be used to support research purposes (Not for clinical use).

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Overview of drug formulation

Pharmaceutical products are formulated products with specific dosage forms for efficient delivery and product stability. Formulation development serves the purpose to determine the optimal dosage form, composition and manufacturing route for pharmaceutical products.

Formulation development

There are different kinds of pharmaceutical dosage forms such as:

  • Oral tablets
  • Capsules
  • Solutions
  • Suspensions
  • Topical ointments
  • Gels
  • Injections for intravenous (IV), intramuscular (IM), or subcutaneous (SC) administration.

They require different production technologies and at the same time present different challenges for the study. DOE (design of experiments) is used as a routine for formulation development, and it evaluates all potential factors simultaneously, systematically, and quickly.

Steps of formulation development

A formulation contains the active pharmaceutical ingredient (API) and other inactive excipients.

  • Firstly, excipient compatibility studies. Aiming to select viable excipients that are chemically and physically compatible with the API(s). The excipients selected during the excipient compatibility study are incorporated into the process feasibility study using DOE.
  • Next, selecting the final excipients and define the optimal levels for all excipients in the formulation.
  • Finally, designing and conduct a formulation optimization study to optimize the excipient levels in the final formulation system.

Formulation Solutions

Creative Peptides offers quality solutions for the development and production of liquid and solid pharmaceutical formulations, including but not limited:

  • Syringe filling
  • Vial filling (Bulk)
  • Oral solid dosage
  • Continuous manufacturing
  • Tablet compression
  • Capsule filling
  • Fluid bed systems

Peptide Formulation Development

Due to the specific interaction of peptides with their targets, peptides can exhibit increased potency and selectivity, with the potential to reduce off-target side effects and lower systemic toxicity. However, the disadvantages of peptide drugs, such as low oral bioavailability, poor membrane permeability and metabolic barriers, limit their wide application. Therefore, formulation development of peptide drug molecules is particularly critical, and the development of new drug delivery technologies has stimulated great potential for peptide therapies.

Examples of formulation strategies to stabilize peptides

Stability riskFormulation strategy
SolubilityOptimization of ionic strength
Addition of solubilizing excipients
HydrolysisAddition of buffer excipients to control pH
OxidationAddition of antioxidants
Addition of chelating agents
Maintenance of pH<7
AggregationAddition of buffer excipients
Optimization of ionic strength
Addition of surfactants, co-solvents
AdsorptionAddition of surfactant and polymer excipients
Addition of albumin
Surface modification
DenaturationAddition of salts or metal ions
Appropriate pH
Microbial contaminationAddition of preservative excipients

Why Choose Creative Peptides?

Quality control and impurity study

  • Systematic and rapid analysis method development
  • Comprehensive, full quality and impurity studies
  • pharmaceutical impurity testing and identification analysis
  • Analysis method validation in accordance with ICH, FDA, EMA and NMPA
  • Quality standard development
  • Stability studies

Formulation and process development

  • Quality by Design (QbD) - quality target product profiles (QTPP), critical quality attributes (CQA)
  • Systematic and comprehensive process research
  • In-depth study of generics and their reference drugs
  • Formulation compliance with FDA Q3 standard
  • Insoluble peptides formulation solution

Formulation Facility

All equipment in the production area is in compliance with cGMP.

  • Fully automatic dosing system: liquid dispenser, sterile storage tank.
  • Handle large or critical quantities with vacuum conveyors, liquid dosing stations, or container for sterile or toxic substances.
  • Low and high shear mixers, high performance homogenizers and emulsifiers, and vibration mixers for mixing and homogenizing solutions, suspensions and emulsions.
  • Aseptic filtration or sterile processing.
  • Fully integrated and automated system.
  • Filling line with clean-in-place (CIP) and steam-in-place (SIP).
  • Through process water system.
  • Pulsating vacuum sterilizer.
  • Automatic container cleaning equipment.
  • Program, production and batch management.

Lyophilization (Freeze-drying)

  • Flexible batch management, gram to kilogram scale
  • Purity >98.5%
  • Full screening of purification conditions
  • Freeze-drying process development

Creative Peptides offers design and optimization of formulations from early pre-clinical stage to Phase I and Phase II clinical trials and commercial manufacturing. We are dedicated to help you achieve the optimal formulation for your APIs.

Reference

  1. Bak, A., et al., Physicochemical and Formulation Developability Assessment for Therapeutic Peptide Delivery—A Primer, AAPS J., 2015, 17(1): 144-155.
* Please kindly note that our products and services can only be used to support research purposes (Not for clinical use).
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