Transdermal patches deliver the drug through the skin (epidermis, dermis and subcutaneous tissue) into the blood circulation and reach the effective blood concentration for systemic action. Transdermal patches can avoid the interference of hepatic priming and gastrointestinal factors, and achieve sustained drug release for a predetermined period of time by controlling the delivery rate. Transdermal patches are currently the most widely used formulation in transdermal drug delivery systems (TDDS) and can be used in sleeping, comatose patients who cannot swallow and can be removed at any time.
Our Services
As an innovative mode of drug delivery, transdermal patches provide a more convenient and effective treatment pathway for patients and have become a global R&D hotspot. Evaluating the consistency of generic transdermal patches is a multilevel and multidimensional process that requires a combination of in vitro and in vivo studies in order to provide patients with more reliable treatment options. Alfa Chemistry specializes in providing comprehensive consistency evaluation services for generic transdermal patches, aiming to ensure that generics are consistent with the RLD in terms of quality and efficacy, as well as meeting the requirements of regulatory agencies.
Regulatory Consulting and Training
EMA and FDA have issued guidelines related to generic transdermal patch consistency assessment. Our team of experts is well versed in transdermal patch regulations and guidelines. We provide our clients with standard interpretation and consulting services on the relevant regulations of various regulatory agencies, and can assist pharmaceutical companies in conducting professional in-house training.
Formulation and Process Research
The FDA and EMA requirements for prescription composition of generic transdermal patches are basically the same, i.e., the active ingredient, dosage form, specifications, excipients, and dosage are the same as those of RLD. We conduct systematic comparative studies using RLD as a reference to ensure the consistency of generic drugs and RLD in terms of dosing.
Quality Study
We conduct comprehensive quality studies for generic transdermal patches, including product specifications and key quality attributes. Our studies are designed to ensure that the product specifications are the same as those of RLD and that the key quality attributes are not lower than those of RLD.
Product specifications in the U.S. and EU are currently expressed in terms of delivery rate, i.e., delivery volume/release time, which can be derived from Pharmacokinetics (PK) data or residual drug analysis data. Generic drugs may have different drug loading and patch area compared to RLDs, but should generally have the same or higher patch area activity and should ensure that the same dose is delivered in the same amount of time and should minimize drug residues.
Key quality attributes of transdermal patches include in vitro drug release, skin permeability, adhesion, cold flow and drug residues.
Bioequivalence Evaluation
In addition to the BE study using PK parameters as evaluation indexes, an adhesion study and irratation and sensitization (I/S) study are also required by EMA and FDA, but there are some differences in the specific implementation details.
The bioequivalence study of transdermal patches has its own special characteristics in overall design, dose selection, evaluation indexes, test procedure, statistical analysis and other aspects, which is exactly where our specialty lies.
Document Preparation and Submission
Our team of experts has rich experience of successful generic filings and can efficiently prepare the application materials for our clients and submit them through the right channels. After submission, we closely monitor the regulatory review process and are ready to assist our clients in answering regulatory questions and submitting additional information in a timely manner.
Small differences in excipients and processes between generic transdermal patches and RLDs have the potential risk of leading to differences in safety and efficacy between the two. Our goal is to help our clients achieve efficient, compliant and competitive product development in the transdermal patch field. Our team consists of experienced industry experts who have a deep understanding and practical experience in drug development, manufacturing and regulatory requirements, providing our clients with comprehensive and professional consistency evaluation services.
