Pre-prescription studies involve the determination of certain basic physicochemical properties of potential drug molecules and other derived properties of active pharmaceutical ingredients (APIs). These studies have gradually become routine for the dosage form and formulation design and improvement, providing a basis for further design of dosage forms and optimization of formulation processes.
Our company provides professional pre-prescription research services to its customers for pre-prescription studies, prescription screening and pre-prescription studies of drug formulations. This is crucial in determining the best formulation and delivery technique for the primary medicine candidate of the customers.
Service Overview
The main content of Our company's pre-prescription research work is to obtain various information required for the dosage form and formulation design by reviewing domestic and international literature or conducting experimental studies, including physical properties, melting point, particle size, solubility, dissolution rate, the crystal form of the drug, as well as inherent physicochemical properties of the drug such as pKa, partition coefficient, surface characteristics, drug stability, compatibility of the drug with excipients, the pharmacological effects, drug side effects, and irritation, as well as drug absorption, distribution, metabolism, and excretion in the body.
Our pre-prescription studies are characterized by both formulation selection and drug preparation. For small amounts of active pharmaceutical ingredients or candidate compounds with medicinal properties, we provide professional pre-formulation services to uncover valuable information.
Research Capabilities
Our company has a wealth of experience developing preclinical formulations for liquid dosage forms, dispersion systems, and solid dosage forms. For molecules with poor water solubility, preclinical formulation development is frequently a challenging area. To meet the unique requirements of your project, our laboratory can conduct small-scale testing.
| Preclinical evaluation of candidate compounds | Solubility | - Solubility in organic solvents.
- Acid-base solubility curves.
- Solubility of compounds in different salt forms.
- Solubility of simulated fasting intestinal fluid, simulated feeding intestinal fluid, and simulated artificial gastric fluid.
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| Stability | Solution stability, solid-state stability |
| Intrinsic Properties | Dissociation constant (Pka), oil-water partition coefficient (LogP), apparent partition coefficient (LogD), characteristic solubility, etc. |
| Crystallographic Studies | Crystal Form Research | - Melting point, solubility, particle size of crystals, etc.
- Stability study of the crystalline form, influencing factors conditions to examine the stability of the crystalline form.
- Trans-crystallization study of the proposed crystalline form.
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| Process Research of The Proposed Crystal Form | - Stirring method, resting, stirring.
- Crystallization methods (natural, cooling, crystalline species).
- Drying process (moisture criteria, determination of water of crystallization - TG, DSC, single crystal incubation, drying method, drying temperature).
- Formulation process simulation (grinding, wet granulation, tablet pressing, etc.)
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| Quality Standards for The Proposed Crystal Form | Melting point, solubility, particle size. IR, x-ray, DSC, TG. |
| Formulation Selection | Particle Size Distribution | Wet or dry method |
| Carrier Screening | Interaction of API with selected excipients: compatibility, dissolution rate, etc. |
| pH Adjustment and Co-solvent Selection | Solubility under water and solutions with pH values of 1.2, 4.5 and 6.8. |
| Hygroscopicity | Weight gain in 24 hours under different humidity conditions. |
| Fluidity | The angle of repose or Carr's index is used to evaluate. |
| Residual Solvent | Detection method of the gas phase. |
| Compatibility study of drug prescription ingredients and drug packaging materials. |
| Microscopic observation, melting point, Pka, moisture, optical isomers, related substances, etc. |
Overall Solutions
| Project Name | Preformulation Study Service |
| Scope of Services | - Preformulation studies
- Gel prescribing studies
- Capsules
- Tablets
- Prescription screening of granules
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| Deliverables | Original images and raw data.
A complete experimental report, including experimental materials, experimental procedures, and experimental results. |
| Cycle | Decide according to your needs. |
If you want to know more about service details, please feel free to contact us.
Related Services
It should be noted that our service is only used for research, not for clinical use.
