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Topical Skin Preparation Formulation
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2022-06-01
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Medicilon offers a professional formulation technology platform, keeping up with the pace of innovation in drug research and development, and meeting the diverse requirements of our clients. Medicilon supported a number of innovative drugs to complete the R&D and receive approval for clinical use.

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R&D Platform for Topical Skin Preparations

Medicilon’s R&D Platform for Topical Skin Preparations can undertake the development of ointment, cream, gel and other semi-solid preparations. Medicilon has completed the R&D and filing of several topical preparation research projects for pharmaceutical companies and scientific research units.

Quality Study of Topical Preparations

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Case Study 1 – Ointment

Rx The excipient type and quantity (Q1 and Q2) of the generic drug is equivalent to the reference listed drug (RLD).
Effects of excipient’s quantity on permeation of skin were studied.
Primary objective was to analyze excipient parameters such as viscosity, degree of polymerization, molecular distribution, etc, .
Method was modified to prevent batch variation, nonuniformity and rheological properties change in the final product.
Process Preprocessing of raw materials, alternative method of addition, melting point, shear velocity, preparation temperature and time.

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Case Study 2 – Compound tincture

Rx Background An improved new drug, category 2.3.
A compound tincture with low API proportion and complex excipients .
Antibacterial efficacy studies was conducted to select the proper bacteriostatic agents and quantity.
Process Method of addition of raw materials, the order of adding excipients, time and temperature for emulsification, shear velocity and time.
Packaging Comparison and selection of alternative packaging materials from validated vendors.
Analysis Sample preprocessing.
Impurity profiling.
Technical Challenges and Resolution Medicilon CMC team modified the addition method and determined adding API after cooling as a solution can solve the lows stability issue.
Conducted extensive literature and market research on individual formulations on behalf of the client.
Focused on tincture rheology and provided formulation development of the current Rx.
Improve and ensure the feasibility of the process for scale-up, from 2kg→5kg→20kg→50kg→200kg.
Complete curve of shear stress and shear velocity, yield stress and creep test and viscoelasticity.
Study the relationship between emulsion size and stability, and control the appropriate particle size of the sample.

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Medicilon can support your development process of various topical skin preparations, including ointments, creams, gels and other semi-solid preparations, as well as lotions, liniments and other solutions. Medicilon fully complies with all relevant global laws and regulations, and has many years of development and research experience. Medicilon has completed the development and application of a number of external preparation research projects for pharmaceutical companies and scientific research institutes. (More details about Skin Topical Preparation R&D )
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