Our Core Services
Pre-formulation Studies
Studies investigating the suitability of excipients and their impact on product characteristics, and microstructure are crucial in developing a stable and effective product. The expert team at TPT LLC has decades of experience in pre-formulation studies and formulation development and is dedicated to providing excellent support to its clients.
Formulation Development of Dermal Products
Determining the right product type, optimization of composition, and quality attributes are critical in developing successful topical products. The manufacturing variables play a major role in determining the product characteristics as well. The expert team members at TPT LLC have been assisting their clients in developing dermal, mucosal, and nail products.
Characterization of Topical Products
The characterization of quality attributes of topical products (Q3 characterization) involves the development and validation of custom-made protocols. TPT LLC team has a long track record of working on the development of novel tools and methods to characterize complex topical creams, gels, and foam products. The project was funded by USFDA and the outcome of this project was instrumental in formulating product-specific guidance of bioequivalence of complex topical generic products. TPT LLC team has expertise in performing rheological evaluation, globule size distribution, particle size distribution, buffer capacity, water activity, drying rate, and other product-specific characterizations.
Topical Formulations and Critical Quality Attributes (fda.gov)
In Vitro Permeation Testing (IVPT) across Human and Animal Skin
Evaluation of the performance of topical products by in vitro permeation testing across a suitable skin model is a standard experimental tool recommended by regulatory bodies. However, it requires a unique skill set, experience, and knowledge, to perform the studies appropriately. TPT LLC is set up with Franz diffusion cells and other accessories to evaluate topical products. TPT LLC was funded by the USFDA to conduct research on in vitro permeation testing of dermal products. Indeed, TPT LLC is one of the leading contract services laboratories providing IVPT services.
In Vitro Permeation Testing Across Mucus Membranes
Topical products that are intended for application onto the mucous membranes (vaginal, buccal, sublingual, and rectal mucosa) can be tested using a modified diffusion cell apparatus. TPT LLC team has mastered the technique of isolating the mucus membranes, testing their integrity, and conducting permeation studies across the isolated human and animal mucous tissues.
Development and Evaluation of Nail Products
Onychomycosis (fungal infection) and nail psoriasis affect the nail apparatus (nail plate, bed, and matrix). These are the two most prevalent nail diseases. TPT LLC team has the expertise to develop formulations for the delivery of drugs across the nail plate. We have developed a high throughput method to screen permeation enhancers for use in topical formulations to improve their drug delivery efficiency. We have conducted several research projects to evaluate nail products across the human nail plate and cadaver toe model.
In vitro release testing (IVRT using Franz diffusion cells or USP dissolution Apparatus with immersion cells)
A standard tool recommended by the USFDA to evaluate the release profile of topical products. The protocol involves thorough screening of a suitable membrane and, the development of a product- specific testing method for the evaluation of topical ointment, creams, gels, and solid matrix dosage forms intended for topical application. TPT LLC can develop the IVRT protocol and compare the performance of generic products with an innovator product.
Analytical method development
TPT LLC also offers analytical services. We develop a suitable analytical method for the quantification of APIs in different formulations (topicals, tablets, capsules, and other dosage forms). We also analyze biological samples, dissolution studies, and diffusion study samples.
