IVRT & IVPT

In Vitro Release Testing (IVRT)

IVRT services include:

• Support formulation development and optimization
• Quality control, product performance testing and shelf-life stability programs
• In Vitro release rate comparison testing for pre and post-changes formulations, confirm a product’s “sameness”
• Bioequivalence (BE) as per FDA Project Specific Guidances (PSG) and the 2016 U.S. FDA Draft Guideline for Acyclovir Cream
• IVRT/IVPT Studies following the EMA Draft guideline on quality and equivalence of topical products (CHMP/QWP/708282/2018)
• Full compliance method development and validation with SUPAC-SS (as per FDA) and USP general chapter <1724> guidance

Our team is deeply experienced in operating Franz Cell and Enhanced Cell systems for semisolid, pulmonary and rectal/vaginal formulations and routinely works with synthetic, biomimesis and tissue membranes, including human and animal skin.

Our expertise also extends to paddle over disk apparatus for transdermal patches. As a result, we can meet the challenges of the most complex in vitro release tasks while keeping to strict timelines in a cost-effective manner.

We offer best-in-class IVPT method development, validation and testing services according to FDA, PSGs, EMA and OECD 428 testing guidelines. Our IVPT testing focuses around the study of skin percutaneous absorption and the cutaneous pharmacokinetics by the determination and evaluation of permeation amount and rate of active compounds. The same testing can also be applied for studying transdermal permeability and metabolic stability of active compounds as well as effects of other composition changes in formulation. Distribution of active compounds in different skin layers can be also investigated.

Ongoing IVRT Testing Services

Post-submission planning for your topical NDA/ANDA can be complicated. Diteba can help streamline the process with our Release and Stability testing services.

In Vitro Permeation Testing (IVPT)

Our IVPT services support the following studies:

• Formulation Development and Optimization
• Preclinical phase
• Phases I-III studies
• Bioequivalence and Bioavailability
• Toxicology
• Irritation assessment (safety evaluation of pharmaceutical or cosmetic)

The in vitro Franz human skin finite dose model has proven to be a valuable tool for the study of percutaneous absorption and the determination of the pharmacokinetics of topically applied drugs. The method has historic precedent for accurately predicting in vivo percutaneous absorption kinetics.

We support the following topically applied dosage forms:

• Creams
• Ointments
• Lotions
• Liquids
• Suspensions
• Gels
• Hydrogels
• Pastes
• Pump Sprays
• Topical Aerosols
• Foams
• Microencapsulation/ Liposomes
• Suppositories
• Nail Lacquers