Liquids offer a fluid approach, addressing challenges related to patient compliance, formulation flexibility, bioavailability, and development speed. Whether it’s syrups, injectables, or oral solutions we have you covered.Scaling up liquid formulations presents unique challenges related to mixing, solubility, viscosity, and filtration. As formulations evolve from feasibility to commercialization, these issues become even more critical. At Renejix, we understand these complexities and offer tailored solutions to help you confidently bring your liquid products to market.
Our Approach
- Integrated Services: Our fully integrated pharmaceutical development and liquid dosage manufacturing services cover oral solutions and suspensions, including pediatric liquid dose forms.
- Seamless Transition: With development facilities co-located within our commercial manufacturing operations, we seamlessly transition from pre-formulation and formulation development to clinical studies and commercial production.
- Expertise: Our liquids expertise is backed by in-house quality and microbiology labs, robust quality systems, and a team of highly skilled technicians.
- Global Reach: We currently supply liquid dosage forms commercially to the US and have the capacity to do so in Canada, Europe, and Asia.
Manufacturing Capabilities
Batch Sizes:
- Liquid cGMP: Ranging from 10 L to 1,000 L.
- Suspension cGMP: Also from 10 L to 1,000 L.
Our manufacturing capabilities span a wide range of technologies:
- Segregated Suites: Ensuring product integrity and compliance.
- Compartmentalized Environment and XP Liquid Compounding: Precise control over processes.
- Controlled Substances (CI – CV): Expert handling of controlled substances.
- Vessel Options: Extensive range of vessel types for various formulations.
- Filtration and Mixing Options: Customized solutions for optimal results.
- Vacuum-Rated, Steam-Heated, and Water-Cooled Jacketed Vessels: Versatile equipment.
- Nitrogen/Inert Gas Blanketing: Ensuring stability and safety.
- HEPA Air Filtration: Maintaining clean environments.
- Light-Sensitive Materials: Facility lighting options for light-sensitive formulations.
Liquid Dosage Formulations
We specialize in both monophasic and biphasic formulations, including:
- Oral Liquid Dosage: Tailored solutions for taste-masking, bioavailability enhancement, and patient compliance.
- Aqueous and Solvent-Based Systems: Versatile options for drug delivery.
- High-Pressure and High-Shear Homogenization: Efficient particle size reduction.
- Oral Suspensions: Controlled release and stability.
- Product Heating and Cooling: Precise temperature control.
Packaging Capabilities
Our liquid packaging lines accommodate a variety of formulations:
- Glass or Plastic Bottles: Sizes ranging from 10 mL to 4 L.
- Quality by Design: Our commitment to quality ensures reliable and consistent products.
Benefits of Liquid Dosage Forms
Enhancing Patient Compliance
- Patient Acceptability: Liquid formulations (such as syrups, suspensions, and solutions) offer better palatability and ease of administration, especially for children and the elderly.
- Improved Adherence: Enhanced patient acceptability leads to better medication adherence, ultimately contributing to improved treatment outcomes.
Versatility and Flexibility
- Formulation Flexibility: Unlike solid doses, liquid formulations provide greater flexibility. Adjusting dosage or delivering specific drug combinations is easier.
- Critical in Pediatrics: Liquid CDMOs excel in tailoring formulations to meet specific patient needs, crucial in pediatric medicine where age- and weight-based dosage adjustments are common.
Optimizing Bioavailability
- Enhanced Bioavailability: Liquid medications often exhibit better bioavailability compared to solid counterparts.
- Quicker Onset of Action: Rapid absorption of liquid drugs leads to faster onset of action, vital in acute treatment scenarios.
Speed to Market and Efficiency
- Efficient Development: Liquid formulation and production processes are often faster and more straightforward than complex solid dose manufacturing.
- Accelerated Timelines: Liquid dosage formulates enable pharmaceutical companies to respond swiftly to market demands and regulatory requirements.
Related Services
FAQs
Here are some frequently asked questions about Liquids.
Renejix provides comprehensive liquid formulation services, including pre-formulation, formulation development, stability studies, and scale-up. We specialize in solutions, suspensions, emulsions, and other liquid dosage forms, ensuring high bioavailability and patient compliance.
With our state-of-the-art equipment and experienced team, we can cut up to 20 weeks off your early and late phase timelines. Our streamlined processes and proactive risk mitigation strategies ensure faster development without compromising quality.
Our liquid formulations are designed for maximum efficacy and safety. We employ advanced technologies and innovative approaches to enhance bioavailability and ensure controlled release, even for the most challenging APIs.
Absolutely. We have the scalability to adapt to your evolving needs, from early development stages to large-scale production. Our facilities are equipped to handle all batch sizes, ensuring a reliable supply for global markets.
Quality assurance is at the core of what we do. We guarantee product integrity and timely market entry by adhering to stringent industry standards and employing comprehensive analytical testing and method development for quality and validation.
Our management team averages over 30 years of industry knowledge. This wealth of experience ensures that your liquid formulation projects are guided by proven professionals who are well-versed in the latest pharmaceutical development techniques.
We have dedicated scientists, engineers, and quality personnel who specialize in pharmaceutical technology transfers. This ensures a seamless transition of your liquid formulation projects from one stage to the next, maintaining consistency and quality throughout.
We offer strategic regulatory planning and quality assurance to ensure global compliance. Our team supports product lifecycle management, streamlining approvals to facilitate a smooth path to market for your liquid formulations.
Yes, we offer comprehensive, end-to-end capabilities that support the entire pharmaceutical development and manufacturing process for liquid formulations. This includes everything from preclinical development to commercial production, providing you with a one-stop-shop solution for all your CDMO needs.