Powders and granules are themselves dosage forms. They can be administered directly or serve as intermediates in the production of other dosage forms. Our powders and granules services are tailored to enhance the oral dosage experience, providing patients with an easy-to-use medication alternative. We specialize in the development and manufacturing of high-quality powders and granules that cater to the unique needs of each medication.
Why Powders & Granules?
- Bulk powders and granules are commonly used when large doses are needed or when the drug is unstable in other forms. These bulk forms can be dissolved or suspended in liquid before administration.
- User-Friendly: Powders and granules are a great choice for those who have difficulty swallowing pills. They can be conveniently mixed with food or dissolved in drinks for easy ingestion.
- Precise Dosing: With powders and granules, dosing can be accurately measured to ensure effective treatment.
- Stable Formulations: Our powders and granules are designed for long-term stability, maintaining their potency and efficacy.
Oral Administration
- Powders for oral administration are formulations consisting of solid, loose, dry particles of varying fineness. They contain one or more active substances, along with excipients and, if necessary, dyes and flavoring agents.
- Granules are aggregates of powder particles with a size range of 200-4000 μm. They are commonly used as intermediates in tablet manufacturing.
Advantages of Powders and Granules
- Improved Flow Properties: Granulation helps prevent segregation of the constituents in the powder mix, enhancing flow properties.
- Enhanced Compaction Characteristics: Granules improve the compaction behavior of the mix, making it suitable for tablet compression.
- Reconstitution: Some powders are reconstituted just before use to avoid chemical degradation. Examples include antibiotic powders for syrups and powders for injection.
Pharmaceutical Granulation Processes
- Dry Granulation (Roller Compaction): Involves compacting powdered materials without using liquid binders. It’s suitable for moisture-sensitive drugs.
- Wet Granulation Techniques:
- Shear Granulators: Use mechanical force to form granules.
- High-Speed Mixer Granulators: Combine mixing and granulation in one step.
- Fluidized-Bed Granulation: Granules are formed by spraying a binder solution onto fluidized powder particles.
- Extrusion-Spheronization: Extrude wet mass through a screen to form cylindrical granules.
- Spray Drying: Convert liquid formulations into granules by spraying them into a hot drying chamber.
Our Powders & Granules Services
- Customized Formulations: We create powders and granules that are specifically formulated to optimize the release and absorption of the medication.
- Advanced Production: Our state-of-the-art facilities are equipped to manufacture powders and granules to the highest quality standards.
- Quality Assurance: We conduct extensive testing to ensure that our powders and granules meet all quality benchmarks.
Advantages of Our Services
- Expertise: The mechanism of granule formation influences their structure and properties. Factors affecting granule formation include particle bonding mechanisms, particle size distribution, and process parameters. Our team of pharmacists and scientists are well-versed in the complexities of powders and granules formulation.
- Patient-Centric: We focus on developing powders and granules that are convenient for patients to incorporate into their daily routines.
- Regulatory Compliance: Our powders and granules are produced in compliance with all regulatory standards, ensuring safety and efficacy.
FAQs
Here are some frequently asked questions about Powders & Granules
Renejix provides comprehensive CDMO services for powders and granules, including formulation development, analytical testing, and large-scale manufacturing. We ensure that your product meets the highest quality standards with our state-of-the-art equipment and experienced team.
With our advanced technologies and efficient processes, we can cut significant time from your development and manufacturing timelines. Our goal is to help you achieve faster time-to-market without compromising on quality.
Absolutely. We have the capacity and flexibility to scale your products from early development stages to large-scale production, ensuring seamless transition and consistent quality throughout the lifecycle of your product.
Quality is at the core of what we do. We adhere to stringent industry standards and regulatory requirements, providing comprehensive quality assurance and control to guarantee the integrity and safety of your products.
Yes, we do. We understand that each product is unique, and we offer customized solutions tailored to enhance efficacy, bioavailability, and patient adherence for your powders and granules.
Our regulatory services team is well-versed in global compliance requirements. We provide strategic regulatory planning and quality assurance to streamline approvals and support your product’s lifecycle.
We offer comprehensive analytical services, including method development, validation, and quality testing, to ensure that your powders and granules meet all necessary compliance and quality benchmarks.
Yes, our dedicated team of scientists, engineers, and quality personnel specialize in pharmaceutical technology transfers, ensuring a smooth and efficient process from development to manufacturing.
Our extensive experience, cutting-edge technology, and commitment to quality make us a trusted partner in the CDMO space. We work closely with you to address challenges and deliver solutions that meet your needs and exceed expectations.