Transdermal delivery systems are designed to deliver an active ingredient (drug substance) across the skin and into systemic circulation, while topical delivery systems are designed to deliver the active ingredient to local tissue. Both delivery systems present similar manufacturing and quality control concerns and similar risks to patients.
Primera has experience with both transdermal patches and topicals. We understand that studies have to be designed to measure the critical quality attributes (CQA). These attributes or characteristics could be physical, chemical, biological and microbiological. Criteria should be set for the attributes to be within a certain range, limit and distribution. Primera will work with you to determine whether your product is safe and your product achieves the requirements delineated in your CQA.
Primera conducts transdermal patch and topical studies by utilizing instrumentation such as Dissolution, HPLC, UPLC, GC, GC-MS, LC-MS. We can do method development, validation, verification, release, stability setup for our clients.
Experienced with:
Assay/Related Compound, Dissolution
Cold flow
Levulinic Acid
Residual solvent/Monomer
Genotoxic Impurity
Identification of API and unknown impurities
Permeation
Physical methods:
Microscopic Evaluation for Crystal Growth
Package integrity
Cold flow
Centering of Patch on Integrated Overlay
Adhesion Release
Probe Tack
Shear
Interlaminar Adhesion Force
Contact Primera and we will facilitate your product development through efficient and cost effective studies.
