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.
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.
A formulation contains the active pharmaceutical ingredient (API) and other inactive excipients.
Creative Peptides offers quality solutions for the development and production of liquid and solid pharmaceutical formulations, including but not limited:
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.
| Stability risk | Formulation strategy |
| Solubility | Optimization of ionic strength |
| Addition of solubilizing excipients | |
| Hydrolysis | Addition of buffer excipients to control pH |
| Oxidation | Addition of antioxidants |
| Addition of chelating agents | |
| Maintenance of pH<7 | |
| Aggregation | Addition of buffer excipients |
| Optimization of ionic strength | |
| Addition of surfactants, co-solvents | |
| Adsorption | Addition of surfactant and polymer excipients |
| Addition of albumin | |
| Surface modification | |
| Denaturation | Addition of salts or metal ions |
| Appropriate pH | |
| Microbial contamination | Addition of preservative excipients |
All equipment in the production area is in compliance with cGMP.
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.
Formulation development involves excipient compatibility studies, selecting final excipients, and optimizing excipient levels to create a stable, effective formulation. A systematic approach, such as Design of Experiments (DOE), is often used to evaluate all factors.
Peptide formulation focuses on overcoming challenges like low oral bioavailability, poor membrane permeability, and stability issues. Formulation strategies include optimizing ionic strength, using antioxidants, and adding surfactants to stabilize peptides.
Solubility can be enhanced by adding solubilizing excipients, optimizing ionic strength, and using appropriate buffer systems to maintain pH balance, ensuring better peptide stability and absorption.
To stabilize peptides against hydrolysis and oxidation, buffers can be added to control pH, antioxidants can be incorporated, and chelating agents may be used to prevent metal-induced degradation.
Surfactants and co-solvents help reduce peptide aggregation and improve solubility, which are crucial for the formulation of peptides that are otherwise prone to denaturation and aggregation.
Stability studies ensure that the peptide formulation remains effective and safe throughout its shelf life by assessing factors like temperature, pH, and exposure to light, preventing degradation and maintaining activity.
Yes, Creative Peptides offers formulation solutions from early pre-clinical stages to large-scale manufacturing, including process optimization for both small and large batch sizes, ensuring scalability and consistency in product quality.
Reference
