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Overview
Preformulation studies are an essential step in the pharmaceutical development process, providing crucial information about the physicochemical properties of drug candidates and their compatibility with various excipients. These studies aim to optimize the drug formulation and ensure its stability, efficacy, and safety throughout its lifecycle.
Figure 1. Outline of preformulation
studies [1].
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Chemical Property Determination
Determining chemical properties is critical in formulation development as it provides key information about the behavior, stability and performance of a drug in different formulations. Our company provides you with the most common chemical properties determination services, as follows:
- Partition coefficient (Log P)
- Dissociation constant (pKa or pKb)
- Chirality
- Stability of molecule (chemical degradation in solution, hydrolytic degradation, stability in solvents used in formulation and/or manufacture, dimerization and polymerisation, photostability, pH-dependent stability, oxidative stability, stability-compatibility)
Physical Property Determination
Generally speaking, most of the new chemical entities are in solid form, so bulk and micromeritic properties are the most important properties to be studied at the preformulation stage. The bulk property characterization includes the determination of polymorphism, crystallinity, density, molecular properties (such as deliquescence or hygroscopicity), while the micromeritic characterization includes the determination of particle size, shape, porosity and density. Our company provides you with the following physical properties determination services:
- Solubility (absolute (intrinsic) solubility, molecular dissociation pKa, solubility in various solvents, solubility rate (dissolution))
- Crystalline vs amorphous form
- Polymorphism and pseudo polymorphism
- Deliquescency vs hygroscopicity
- Particle size
- Density and porosity
- Flow properties
Drug Excipient Compatibility Studies
Assessing the compatibility of the drug substance with various excipients is crucial for formulation development. Our company's compatibility studies use techniques such as Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and high-performance liquid chromatography (HPLC) to assess the potential interactions between the drug substance and excipients under different conditions (e.g., temperature, humidity).
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Preformulation studies provide critical insights into the physicochemical properties of drug substances and facilitate the rational design of pharmaceutical formulations to meet regulatory requirements and patient needs. Our company is committed to providing you with specialized preformulation study services. These services are typically conducted in the early stages of drug development to guide formulation strategies and mitigate potential risks associated with product development.
Reference
- Patel, P. Preformulation studies: an integral part of formulation design. Pharmaceutical Formulation Design-Recent Practices. IntechOpen, 2019.