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Controlled Release Formulations

At Roquette, we support formulators in meeting these challenges through specialized controlled release excipients, grounded in decades of pharmaceutical expertise and guided by hands-on collaboration. Our approach combines functional innovation with application support, helping transform complex formulation goals into robust, reproducible outcomes. 

Innovations in Controlled Release: Enhancing Drug Delivery Systems 

Controlled release formulations represent an essential advancement in oral drug delivery, enabling medicines to maintain steady therapeutic levels in the body, reduce dosing frequency, and support greater patient compliance. These dosage forms are designed not only for efficacy but for patient convenience and improved treatment adherence over time. However, developing controlled release systems that perform consistently can be technically demanding. Achieving the right balance between release kinetics, compressibility, and scalability requires precise excipient selection and deep formulation understanding. 

Solutions Tailored to Your Needs

Roquette’s controlled release solutions are engineered to help formulators achieve consistent therapeutic performance, simplified processing, and dependable scale-up. Each solution addresses a specific challenge in developing robust, patient-centered dosage forms. 

Ensuring Predictable Drug Release

Achieving reproducible drug release is central to controlled release success. Roquette supports formulators in developing matrix systems that maintain steady therapeutic levels over time, minimizing fluctuations that can affect efficacy or tolerability. Our excipients are designed to deliver reliable, consistent release profiles that translate from R&D to full-scale production. 

Simplifying Complex Formulations

Controlled release tablets can be complex to develop, with multiple formulation variables influencing performance. Roquette’s excipients and technical support help streamline formulation design, simplifying scale-up and reducing variability. This practical approach enables formulators to focus on performance optimization while improving process efficiency. 

Balancing Tablet Strength with Release Performance

Formulators often face trade-offs between mechanical strength and desired release rates. Roquette helps achieve both, offering excipients that support robust compressibility without compromising controlled dissolution behavior. The result is durable tablets with reproducible, predictable release characteristics. 

Improving Patient Adherence

By supporting dosage forms that release active ingredients gradually over time, Roquette’s controlled release technologies contribute to more convenient treatment regimens. Reduced dosing frequency enhances patient comfort and supports consistent therapeutic use, helping formulators design products that align with real-world patient needs. 

Supporting Scale-Up and Regulatory Confidence

With formulation development often extending from lab to commercial scale, maintaining quality and performance consistency is critical. Roquette’s Customer Technical Services (CTS) laboratories provide global expertise and hands-on support, ensuring that controlled release systems developed in early stages translate reliably to manufacturing environments

Our Services and Expertise

Roquette’s innovation in controlled release formulation extends beyond excipient functionality to include comprehensive technical partnership. Through its global network of Customer Technical Services (CTS) laboratories, Roquette provides direct access to formulation experts who help optimize performance, troubleshoot development challenges, and support regulatory readiness. 

This integrated approach ensures that formulation concepts translate effectively into manufacturable solutions, from early-stage R&D through to commercial production. Backed by Roquette’s global quality standards and decades of experience in excipient science, customers can confidently develop controlled release products that are both efficient and dependable. 

Simplifying Controlled Release Formulation

Roquette offers excipients designed to simplify controlled release formulation while ensuring consistent performance, robust manufacturability, and reproducible therapeutic delivery. 

KLEPTOSE® beta-cyclodextrins

KLEPTOSE® beta-cyclodextrins enhance formulation stability by improving solubility and protecting APIs within controlled release matrices. Their inclusion supports uniform performance and formulation flexibility across a wide range of actives.

PEARLITOL® CR-H co-processed mannitol

PEARLITOL® CR-H co-processed mannitol combines mannitol and hydroxypropyl methylcellulose (HPMC) in a directly compressible, co-processed excipient that streamlines controlled release formulation. Its optimized composition helps reduce variability, enhance reproducibility, and support the development of matrix systems with reliable, consistent release performance. 

PEARLITOL® 200 GT mannitol

PEARLITOL® 200 GT mannitol powder for direct compression delivers excellent tabletability in formulations with higher active ingredient loads. It supports both mechanical integrity and controlled release function, contributing to strong, consistent tablets that maintain the intended dissolution behavior. 

 

Solve your challenges

  • Advanced Drug Delivery Systems

    Enabling controlled and targeted release with multifunctional excipients and advanced formulation technologies.

  • Bioavailability Enhancement

    Functional excipients that improve solubility and absorption of poorly soluble active pharmaceutical ingredients (APIs).

  • Biologic Challenges

    Specialized excipients to enhance biologic stability, viscosity control, and process efficiency.

  • Dry Powder Inhalation (DPI) Solutions

    High-purity carriers supporting dose uniformity and aerodynamic performance for DPI formulations.

  • Patient- and Consumer-Friendly Coating Solutions

    Coating systems that enhance swallowability, taste, and appearance for improved patient adherence.

  • Quality, Regulatory and Formulation Support

    Expert guidance to meet pharmacopeial standards and accelerate formulation development.

  • Reducing Nitrosamine Risk

    Excipients and process solutions designed to minimize nitrosamine formation while maintaining formulation integrity.