Pre-formulation Development

To avoid drug failure and eliminate delays or holds of preclinical or clinical development, Creative Biolabs offers the pre-formulation development solutions.

Formulation studies aim to develop a drug preparation which is both stable, safety and acceptable to the patient. Pre-formulation studies are an essential component of drug development process, and it provides the scientific basis for formulation development. It gives the physical, chemical, and mechanical properties of a new drug and helps researchers choose what ingredients (excipients) should be used in the preparation.

Pre-formulation studies can be classified into several aspects. Firstly, characterize fundamental properties. This includes understanding the solubility in different solvents, dissociation constant (pKa), partition or distribution coefficient (logP or logD), pH, permeability, solid state stability, solution state stability, etc. Secondly, screen an appropriate salt, polymorph, solvate forms and amorphous form. Thirdly, understand the derived pre-formulation properties like morphology, particle size, bulk density, etc. The last activity performed in pre-formulation studies is the excipients compatibility studies, to investigate the stability of the drug molecule in the presence of excipients.

Pre-formulation Development

Creative Biolabs provides the following services to support your pre-formulation works.

Physicochemical Characterization

Physicochemical properties of drugs include the aspects of Ionisation, stability, solubility in different solvents, dissociation constant (pKa), partition or distribution coefficient (logP or logD), pH, permeability, particle size, bulk density, etc. Creative Biolabs provides aqueous solubility, lipophilicity, and stability studies to meet all your demands.

Purity Determination

Creative Biolabs provides precise measurements of heats by DSC and gives sufficient information to support successful purity determinations. The DSC is the simplest analytical method for getting information about the purity and the crystaI form of the sample under investigation. Temperature provided can range from -120°C to 725°C and the temperature is measured with a repeatability of ±0.1°C.

Salt Selection

Selecting an appropriate salt for a new drug provides the opportunity to modify the drug candidate's characteristics and to permit the dosage forms with good bioavailability, stability, and manufacturability. Salts are most commonly employed for modifying a drug's physicochemical properties like solubility, dissolution rate, hygroscopicity, chemical stability, crystal form, and mechanical properties. With our understanding of salts, we are able to screen the suitable salt rapidly and economically.

Polymorphism Screening

Polymorphism is the ability for a single pharmaceutical entity to form two or more crystalline phases. Generally, there is only one desired active polymorph. The polymorph form can severely impact physical characteristics and stability, and it is critical to choose an optimum solid form to improve bioavailability. Creative Biolabs has the ability to perform screening of polymorphic forms for your active pharmaceutical ingredient (API) and analyzing different forms. Our state-of-the-art X-Ray Powder Diffraction (XRPD), Differential Scanning Calorimetry (DSC) platform and stability, dissolution and solubility studies will deliver you with all the necessary data.

Compatibility Studies and Excipients Selection

Compatibility studies are usually the last activity done during pre-formulation profiling. The studies are aimed at studying the interactions of drugs and excipients. Guided by the type of proposed dosage form, Creative Biolabs will help you select excipients to develop a high-quality drug product, including optional solubilizer, stabilizing agent, buffer, and rate controlling polymer.

Creative Biolabs provides comprehensive pre-formulation studies. For more detailed information, please feel free to contact us or directly sent us an inquiry.



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