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Pharmaceutical Research

Pharmaceutic Preparation

Our Preparation Department is committed to providing clients with one-stop and systematic preparation development service, and can undertake the whole process of preparation R&D innovation from project evaluation and approval, preparation process research, quality standard establishment and research, clinical sample production, application and filing, etc.

We have a professional technology platform for insoluble innovative drugs. With mature and complete technologies such as solid dispersion, micronization, solubilization, inclusion compound, in vitro dissolution/in vivo PK comprehensive evaluation, etc., we can deal with the common solubility and permeability problems of candidate compounds for new drugs.

We also have a professional high-end preparation technology platform. For inhalation administration, ophthalmic administration, transdermal administration, sustained-release administration, and new particulate system administration, our Preparation Department has continuously innovated and improved its technical service platform and accumulated practical experience to meet the requirements of the times and clients.

Service
  • Our Preparation Department is committed to providing clients with one-stop and systematic preparation development services, with the main contents as follows:
    Research on preformulation Research on formulation process Research on preparation quality Laboratory-scale test of preparation Pilot-scale test of preparation GMP-based clinical sample production and packaging Preparation stability test Consistency evaluation
GMP-based Clinical Sample Production & Packaging
In order to better meet the clients’ demand for one-stop service in preparation R&D, we have established a GMP-compliant workshop for oral solid preparations capable of crushing, weighing, mixing, granulating, drying, sieving, tableting, capsule filling, coating and packaging of raw materials while improving the level of pharmaceutical production and quality management system. In that way, we cannot only carry out the R&D, inspection and stability study of generic drugs for clients, but also promise the R&D, production, packaging, inspection and stability study of innovative drugs in clinical phases I and II to enable our CDMO services.
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Formulation Stability Study
Research on the stability of pharmaceutical preparations provides scientific basis for the determination of production, packaging, storage, transportation conditions and validity period of pharmaceutical products by investigating the laws of the changes of the properties of APIs and preparations with time under the influence of temperature, humidity and light, so as to ensure the safety and effectiveness of clinical medication. Stability study is one of the main contents of drug quality control research. It is closely related to drug quality research and the establishment of quality standards.
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Consistency Evaluation
In the quality consistency evaluation of generic drugs, Medicilon has successfully completed a number of quality consistency evaluations. With rich experience in generic drug R&D, we can provide you with more professional consistency evaluation services.
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