A complete range of formulation & analytical services for your next product
CAPTEK Pharma offers end-to-end formulation development as well as independent process development services. We support new products as well as classification for ANDA or 505(b)(2). We are proficient in formulating from scratch for the OTC market. Alternatively, for customers that already possess a developed formula, we can perform gelatin compatibility and provide pre-formulation screening work.
Our robust data-based formulation methods are strategically leveraged at initial softgel development to maximize the benefits of our manufacturing process. This allows us to nimbly and effectively offer scalable solutions that fulfill your market needs.
CAPTEK has vast experience in the development and production of softgel technology. This allows us to be proactive in creating a formulation that works best for your product.
Comprehensive Analytical Capabilities
CAPTEK Pharma develops extensive analytical methods to support formulations respective to your product’s needs. Based on your proposal, we develop a technical consideration plan that includes both the requirements and the development process for your product.
This is conducted hand-in-hand with the analytical lab to ascertain opportunities with newer API or active ingredients, as well as to document the methods, types of reagents, and instrumentation necessary for the analytical methods and dosage form. This is a dynamic process, as each molecule requires specific analytical methods to support a particular formulation.
Preformulation Gelatin Compatibility
To minimize the risk of failure during encapsulation, we conduct preformulation studies that mimic the introduction of water migration to the fill material and determine if seed crystals are formed when the water exits as the capsule dries.
Lab modeling allows us to expose wet gelatin to conditions that would occur during manufacturing to determine if the API stays in solution, if seed crystals form, or if other technical concerns are detected that could impact stability further in development.
Formula Compatibility With The Shell
We rigorously test to determine that our formulation is feasible with a given shell, to ensure the softgel can withstand the encapsulation process. During testing, we conduct lab-scale feasibility studies utilizing complex fill materials, with different orders of addition and excipient levels, to dissolve the drug. When producing pilot batches, we use the actual equipment used for future production batches.
CAPTEK conducts extensive research in the product development stage to generate effective recommendations for a more competent formula, in the event the extreme conditions of the testing suggest there would be stability impacts during the manufacturing process.
Validation Is A Continuous Process
Validation is an ongoing team process. CAPTEK is aligned and ready to validate any softgel product developed by our R&D experts. Methods that we develop for new products and formulations are validated prior to their use in clinical trials, materials release, validation batches, or commercial production.
Speak With An Expert
Product Development Specialist
Over his 25 year career, Tim Chiprich has led teams developing softgel pharmaceuticals, dietary supplements, and cosmetic products. In addition, he’s participated in gelatin research and new technology projects and has several pending and granted patents. Tim is happy to leverage his thorough understanding of softgel development to discuss any challenges on your upcoming project.