Skin Topical Preparation

Medicilon can undertake the development 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 the requirements of global laws, regulations and guiding principles, and can bring many years of R&D experience to support your projects. Medicilon has completed the development and application of a number of external preparation research projects for pharmaceutical companies and scientific research institutes.

The skin is the first line of physical defense in the human body. It is the largest organ of the human body which participates in various physiological functions . It consists of three easily distinguishable layers: the stratum corneum, the living epidermis and the dermis.^[1-3]
Skin diseases are complex and diverse, causing various degrees of disease. Skin topical preparations can act as a local or systemic treatment. Semi-solid topical preparations, a type of common preparation applied in skin medicine, are multiphase in nature, thermodynamically unstable and complex in composition. Semi-solid preparations are classified as a complex preparation and they have applications in the fields of innovative drugs, improved new drugs and generic drugs.^[1-3]

List of Topical Skin Preparations

GelOintmentSolution type ointmentSuspended ointment CreamOil-in-water creamWater-in-oil cream

Medicilon’s Services

Medicilon can undertake the development process of various topical skin preparations, including ointments, creams, gels and other semi-solid preparations, as well as lotions, liniments and solutions. Medicilon fully complies with the requirements of global laws, regulations and guiding principles, as well as possessing years of development and research experience. Medicilon has completed the development and application of multiple external preparation research projects for pharmaceutical companies and scientific research institutes.
Medicilon is well versed in the specificity of semi-solid preparations for skin topical in terms of technology development and review and approval, and considers the product’s prescription technology, quality control, packaging materials, commercial production and clinical application. Based on the analysis of the quality research profile, the key quality attributes (CQAs) of the products are used as the inspection indicators to conduct a screening study on the types and dosages of excipients.
Medicilon can provide study on the Quality of Topical Preparations:
Formulation pHWater Activity Ratio of Undissolved Drug/Dissolved DrugRheological PropertiesCharacterization of Shear Stress and Shear RateYield Stress ValueLinear Viscoelastic ResponseViscosity CurveLinear Viscoelastic RangeIn Vitro Release Test/In Vitro Permeation Test (IVRT/IVPT)Particle Size and Droplet Size Distribution Measurement Establishment of Microbiological Inspection MethodsEstablishment of Test Method for Burkholderia CepaciaEstablishment of Antibacterial Efficacy Method)
Schematic Diagram of Rheological Research in Semi-Solid Formulations
Schematic Diagram of Drug Absorption in Topical Formulations
Schematic Diagram of Rheological Research in Semi-Solid Formulations

Our platform is equipped with state-of-the-art and complete instruments to complete the various test items mentioned above:

Analysis Equipment
Brookfield Viscometer Image Analysis System for Measuring Droplet/Particle Size Distribution HAAKE MARS RheometerFranz Diffusion Cell (with Automatic Sampling System)LC/MS System
Preparation Equipment
Shearing InstrumentHomogenizer Filling Equipment

Reference:
[1] Hyunjae Lee, et al. Device-assisted transdermal drug delivery. Adv DrugDeliv Rev. 2018 Mar 1;127:35-45.
[2] Mark R Prausnitz, et al. Transdermal drug delivery. Nat Biotechnol.2008 Nov;26(11):1261-8.
[3] Muhammad Yasir Siddique, et al. Microemulsified Gel Formulations for Topical Delivery of Clotrimazole: Structural and In Vitro Evaluation. Langmuir. 2021 Nov 23;37(46):13767-13777.