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Pharmaceutical preparation

Pharmaceutical preparation

Medicilon's 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 microparticle drug 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
    Medicilon can undertake a full set of preparation research (including research and development, clinical sample production, stability), safety evaluation, packaging material compatibility, filter membrane verification, packaging sealing, pre-BE and BE research and other services to meet all your needs.
Platform
GMP-based Clinical Sample Production & Packaging
To better meet the clients' demand for a 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. To enable our CDMO services, in addition to carrying out R&D, inspection and stability study of generic drugs for clients, Medicilon can also deliverproduction, packaging, inspection and stability studies of innovative drugs in clinical phases I and II.
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Formulation Stability Study
Research on the stability of pharmaceutical preparations provides a scientific basis for the determination of production, packaging, storage, transportation conditions and the validity period of pharmaceutical products. This is achieved by investigating the parameters of the changes of API properties and preparations with time under the influence of temperature, humidity and light, so as to ensure the safety and effectiveness of clinical medication. Stability evaluation is one of the main components 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 many 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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