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Preformulation Research

2021-07-30
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Medicilon has been offering high quality analytical testing services to the pharmaceutical industry for decades. We offer a wide range of quality control testing services to support drug research, registration and production. Biopharmaceutical companies also use many of the same services and Medicilon has also added new services to accommodate their unique needs (detailed in the following section).

In the process of formulation development, preformulation research is the key investigation item in CTD data, and pre-prescription research has important guiding significance for the development of formulations.

Particle size study

The API is pulverized to different particle sizes by jet pulverization/mechanical pulverization, and the inherent dissolution rate is tested after the particle size is detected. A value lower than 0.1 mg/min/c㎡ usually means that the dissolution rate determines the bioavailability; a value higher than 1 mg/min/c㎡ usually means that the bioavailability is most likely to be determined by the permeability of the drug.

Crystal Form Research

Test the stability of different crystal forms, and the stability of API crystal forms under humidity, heat, and pressure conditions.

Hygroscopicity research

A dynamic moisture adsorption analyzer was used to detect the moisture absorption and weight gain curve of API/preparation intermediates under 5~90%RH conditions to determine the hygroscopicity conditions of API/preparation intermediates, and study the storage conditions of API/preparation intermediates in combination with HPLC.

BCS classification

Measure the saturation solubility curve of API in pH1.0~8.0 buffer, and the stability in each pH value solution; cooperate with DMPK department to conduct Caco test. The two data are combined to determine the BCS classification.

Study on the compatibility of raw materials and excipients

According to the dosage form and product characteristics, carry out the compatibility test of the raw and auxiliary materials, and carry out the inspection.

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