CPL shares expertise on topical semi-solid product development

CPL, a leading topical drug development and manufacturing service provider, recently hosted a webinar that discussed its approach to formulating and developing topical drug products. When it comes to topical products, the Canadian-based company has been a trusted partner for many of the world’s leading pharmaceutical companies and has more than 30 years of experience tackling all the complexities of semi-solid dosages.

MISSISSAGUA, ONTARIO—Development of topical semi-solid products can be complicated as these dosage forms often have complex structural elements and potential risks can arise during the development phase.

CPL, a leading topical drug development and manufacturing service provider, recently hosted a webinar with Chetan Chure, Manager of Formulation Development, that discussed its approach to formulating and developing topical drug products. The Canadian-based company has been a trusted partner for many of the world’s leading pharmaceutical companies with more than 30 years of experience tackling all the complexities of semi-solid dosages.   

Chure covered a number of key topics including the cornerstones of formulation planning, such as the identification of the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs), and Critical Process Parameters (CPPs).

The main focus of the webinar was on Critical Process Parameters and how each group of parameters can have a significant impact on the successful outcome of development. The monitoring of Critical Process Parameters, defined by Chure as “variables that can impact the specifications of the final product” is as crucial as the name suggests.

Six categories of excipients play important roles in topical semi-solid formulation, and there is much to consider when it comes to selecting ingredients from these categories. “Whenever you select an ingredient, you should always keep in mind CPPs or the manufacturing processes you’re going to follow for this particular kind of dosage form,” Chure advises.  

Manufacturing processes naturally follow ingredient selection, and Chure highlighted how necessary a systematic approach with close attention to CPPs is in achieving the product’s QTPP. Chure described the basic manufacturing steps that are involved in the formulation of semi-solid topical products before discussing some important considerations for each stage. He covered a variety of CPPs in detail from temperature ranges and mixing methods to homogenization, pressure, and kettle design. Neglecting details of these parameters could significantly affect the product’s characteristics and quality.

“Scaling-up manufacturing is another area where problems can be encountered,” said Chure. In a section on the heating step, he states the importance of kettle choice. “When we develop our products in the lab, we are utilizing lab-scale equipment to establish basic mixing steps and generally use beakers and heating mantles. When we scale up on the production floor, we have kettles with different designs with multiple heating and cooling options depending on the type of dosage. The kettle design we choose affects heat distribution and the melting of particular kinds of ingredients,” he explained.

Chure also discussed important evaluation parameters, including how to analyse changes in the product’s particle and globule size, viscosity, density or specific gravity, rheology, physical appearance, and performance.

Specialised production methods and carefully selected ingredients and equipment are a necessity of successful semi-solid pharmaceutical development and manufacturing. If followed, Critical Process Parameters can optimise the entire process and ensure a quality and constantly reproducible product throughout the product’s lifecycle. To view the entire webinar, please click the link below.