Kymos Group offers GMP and GLP-certified studies for transdermal patches or Transdermal Drug Delivery Systems (TDDS), providing extensive expertise in their analysis and quality control. These dosage forms are designed to deliver active substances through the skin in a systemic, prolonged and constant way, and they present unique challenges in terms of quality, efficacy, and safety.
Our specialized laboratories are equipped with state-of-the-art technologies and techniques, and our team of experienced professionals maintain the highest standards and regulatory requirements basing our studies on the “Guideline on quality of transdermal patches (EMA/CHMP/608924/2014)”, relevant Pharmacopeial monographs, and ICH and CHMP/CVMP guidelines.
We provide support during the whole life cycle of transdermal patches, from formulation, development and stabilities, to routine analysis and reformulations.
SERVICES
CMC & Quality Control Testing of Transdermal Patches
General Quality Control Analyses
- Assay: Determination of the drug content to ensure it meets the specified concentration.
- Appearance: Assessment of attributes such as color, shape, adhesive matrix, and release liner detachment.
- Related Substances: Identification and quantification of impurities and degradation products to maintain product safety and efficacy.
Specific Tests for Transdermal Patches
- Active Substance Crystallization: Qualitative detection of crystal formation which can impact the patch’s efficacy and safety.
- Residual Solvents: Analysis of residual solvents that might affect adhesion and permeation, with stricter limits than those in ICH Q3C.
- Extractables and Leachables: Identification of extractables from the patch’s multilayer structure and primary packaging, and leachables that may contaminate the drug product.
- Adhesive properties: Characterization of adhesion and cohesion properties to ensure the patch remains attached for the required duration. This includes peel force tests, adhesive strength tests, and tack tests.
- Microbiology: Depending on the application, sterility testing, or analysis of microorganisms and investigation of specific pathogens.
- In-Vitro Release Testing (IVRT) / Dissolution Test: Measurement of the drug release rate from the patch using specialized equipment to prevent patch floating.
- In-Vitro Permeation Testing (IVPT): Evaluation of drug penetration through synthetic or biological membranes, used during formulation development, stability studies, and post-excipient changes.
- Stability Studies: Comprehensive stability testing including ongoing and in-use studies, real-time storage conditions, and stress testing for dissolution, drug release, and skin permeation testing and adhesion.
Why Choose KYMOS?
Services
Related services to Transdermal Testing
Extractables and Leachables
Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.
Method Development, Validation and Transfer
Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.
Contact