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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
Preformulation Study
Our preformulation service features both formulation selection and pharmaceutical preparation. To address low numbers of active pharmaceutical ingredients or candidate compounds with medicinal properties, we provide professional preformulation services delivering critical information.
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Formulation Technology Research

According to the form characteristics, physical and chemical properties and stability of drugs, we conduct process research to determine the preliminarily preparation process of laboratory samples and set corresponding process control indicators.

Our CMC Department has worked successfully with well-known large and medium-sized companies . With more than 10 years' experience in the research and filing of innovative drugs and generic drugs, the department is continuing to develop its capabilities.

We have extensive equipment commonly used in preparation process and quality assessment for preparations including tablets, injections, capsules, granules, ointments, creams, sprays, gels, syrups, tinctures and oral liquid preparations, as well as GMP-based pilot-scale test workshops for oral solid preparations. We are also capable of developing new technologies such as sustained-release preparations, nano preparations and fat emulsions.

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Preparation Quality Research
With decades of working experience, our CMC experts are familiar with various ICH and NMPA regulations and guidelines, and have helped clients complete their preformulation and pharmaceutical preparations studies to provide reliable data for the filing materials. We have successfully assisted a number of clients in completing NMPA and FDA applications for innovative drug and generic drug.
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Laboratory-scale Preparation Testing
Equipped with Tofflon's freeze dryers, Thermo Fisher Scientific's hot melt extruder and Yamato's spray dryers, we are capable of laboratory-scale test for oral administration, injection, external use and various preparations.
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Pilot-scale Preparation Testing
For oral solid preparations, we conduct laboratory-scale production and preliminary stability studies. After the determination of the formulation process, the preliminary stability of samples and identifying the proposed inner packaging materials, we prepare relevant documents and materials for pilot-scale tests.
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