Drug released amounts and rates for transdermal semisolid topical products are measured by means of IVRT using artificial membranes in different topical applications
- Optimization and comparison of different formulations of topical products during the development phase.
- Development and validation of methods to measure release and rates for different formulations of topical products.
- Quality control for in vitro release of manufacturing batches of topical products
Applications
- Topical Formulations Creams, gels, ointments, and lotions.
Topical Formulations
- Ensures the API is delivered effectively across the skin in patches and other transdermal devices.
- Drug-device systems, ensuring that both the API release and device functionality are optimized.
- IVRT data supports NDA, ANDA, and Clinical Trials submissions, demonstrating product quality, consistency, and performance
Transdermal Drug Delivery Systems (TDDS)
Combination Products
Regulatory Submissions
Available Methods
Our available IVRT methods for creams, gels, and ointments are designed to deliver precise, reproducible, and formulation-specific release profiles. Using validated, scientifically robust approaches, we assess drug release performance across a wide range of semi-solid dosage forms, supporting formulation development, quality control, and regulatory submissions. Our methods are optimized to accommodate diverse product characteristics, ensuring accurate evaluation of release kinetics, batch consistency, and product performance — providing reliable data you can confidently build on.
- ✓Acyclovir
- ✓Ammonium Lactate
- ✓Betamethasone dipropionate
- ✓Clindamycine Phosphate and Benzoyl peroxide
- ✓Clindamycine Phosphate, Benzoyl peroxide and Adapalene
- ✓Clobetasol Propionate
- ✓Crisaborole
- ✓Dapsone
- ✓Desonide
- ✓Doxepin
- ✓Hydrocortisone
- ✓Ivermectin
- ✓Metronidazole
- ✓Mupirocin
- ✓Nystatin
- ✓Testosterone
- ✓Tretinoin
Cliantha Advantage
State-of-the-Art Equipment
We use the latest technologies, including Franz diffusion cells, HPLC, and UV/Vis spectrophotometry, to provide precise drug release data.
Expert Analytical Team
Our team of scientists and researchers is highly experienced in conducting IVRT studies, offering insightful analysis and innovative solutions for your specific formulation needs.
Customized Solutions
We provide customized IVRT study designs tailored to the unique characteristics of your formulation, whether it’s a topical cream or a drug-device combination.
Global Compliance
We ensure that all our IVRT studies meet the standards set by FDA, EMA, and ICH guidelines, ensuring regulatory acceptance for clinical trials and market approval.
Comprehensive Data Reporting
Our robust data analysis and reporting ensure that you receive high-quality, reproducible results that are audit-ready and fully support your regulatory submissions.
Transdermal permeated amounts, flux rates, and layer distribution are measured by means of IVPT and skin samples and other tissues in different topical applications:
- Bioequivalence of topical generics as an EMA/FDA-approved biowaiver alternative to costly clinical studies.
- Optimization and comparison of formulations. Selection of suitable excipients.
- Selection of lead candidate formulations for topical products.
- Skin stripping and layering to measure skin penetration- Safety assessments of cosmetic topical products.
- Percutaneous absorption studies through skin
- Evaluation of drug permeation and retention.
- Optimization of rheology, excipient selection, and drug delivery.
- Optimization of rheology, excipient selection, and drug delivery.
- Assessing local delivery and tissue penetration.
- Testing actives in moisturizers, sunscreens, and anti-aging products.
Topical Creams & Ointments
Gels & Lotions
Transdermal Systems- Quantification
Ophthalmic & Nasal Formulations
Cosmeceutical Products
- Acyclovir
- Dapsone
- Hydrocortisone
- Testosterone
- Metronidazole
Cliantha Advantage
State-of-the-Art Equipment
We use the latest technologies, including Franz diffusion cells, HPLC, and UV/Vis spectrophotometry, to provide precise drug release data.
Expert Analytical Team
Our team of scientists and researchers is highly experienced in conducting IVRT studies, offering insightful analysis and innovative solutions for your specific formulation needs.
Customized Solutions
We provide customized IVRT study designs tailored to the unique characteristics of your formulation, whether it’s a topical cream or a drug-device combination.
Global Compliance
We ensure that all our IVRT studies meet the standards set by FDA, EMA, and ICH guidelines, ensuring regulatory acceptance for clinical trials and market approval.
Comprehensive Data Reporting
Our robust data analysis and reporting ensure that you receive high-quality, reproducible results that are audit-ready and fully support your regulatory submissions.
