6 Steps to Ensure Robust Design & Performance of Hydrophilic Matrices
Quality by Design (QbD) is a systematic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality.1 In the case of hydrophilic matrix tablets, using hypromellose as the rate-controlling polymer, it is critical to consider the variability in properties of the polymer2 in addition to the variabilities in API properties and processing conditions.
Keep the following 6 steps in mind when implementing a QbD strategy to ensure the robust design and performance of your hydrophilic matrices.
1. Consider material attributes (MA)
Variations in viscosity, particle size and hydroxypropyl substitution levels (% HP) of the rate-controlling polymer can impact drug release performance of the matrix formulation. Samples to assist QbD are available through Colorcon; supporting proactive risk assessment of these MAs to ensure robust matrix formulation design and performance.
2. Optimize formulation design
Lower formulation risk and improve productivity in the development phase, with a first-time-right approach. By optimizing the formulation in early design phases, manufacturers can avoid costly mistakes in downstream processes. Colorcon’s HyperStart® starting formulation service offers design and process guidance for a wide range of drug doses, solubility and release profile combinations. Request your starting point now.
3. Tap into prior knowledge and expertise
Consult us for case studies, technical knowledge, and recommendations. Leveraging outside resources for formulation and polymer expertise will undoubtedly speed up development processes.
4. Implement a manufacturing control strategy
Manage drug product risk using process trend data to generate a manufacturing control strategy. Limited manufacturing variability of hydrophilic matrix systems will lead to less product rejection and reduced waste.
5. Mitigate regulatory risks
Manage regulatory burden, minimize recalls and compliance actions. Meet first cycle regulatory requirements and reduce supplemental submissions, increasing speed to market.
6. Secure your supply chain
Suppliers should have a thorough business continuity plan and ideally multiple manufacturing sites to deliver security of supply, reduce operational risk, and provide consistent quality and availability of key materials globally.
Colorcon's extensive formulation knowledge focuses on the most important factors that impact the rate of drug release. With Colorcon as Your Formulation Partner™ you can build quality into formulation design reducing the risk of final product rejection, better manage the regulatory burden and lower production cost.
Through the Controlled Release Alliance, Colorcon offers METHOCEL™ Premium Cellulose Ethers, the first choice in polymers for the formulation of hydrophilic matrix systems, providing a robust mechanism for the controlled release of drugs from oral solid dosage forms.
Connect with Colorcon to learn more about how you can incorporate a strategic QbD approach into your hydrophilic matrix formulation.
- Yu, L. X., Pharmaceutical Quality by Design: product and process development, understanding, and control. Pharmaceutical Research 2008:25(4): 781-791.
- Cabelka, T., Faham, A., Bernthal, H., Rajabi-Siahboomi, A., Application of Quality by Design (QbD) principles to the formulation of a hydrophilic matrix tablet of a high dose/high solubility drug. AAPS annual meeting and exposition, Los Angeles, CA 2009.