Overcome the hurdles of poorly soluble compounds by leveraging Renejix’s spray drying to engineer particle size and greatly enhance bioavailability. Spray drying is crucial in transforming the pharmacokinetics of drugs, ensuring they reach their therapeutics targets efficiently.
We offer spray dried dispersion (SDD) solutions that encompass the entire journey from early development to clinical supply, and ultimately to the scaling up of finished dose forms for commercial production at both of our facilities.
Why Spray Drying?
A spray dried dispersion (SDD) is a molecular dispersal of a drug within a polymer matrix. This intricate formation is achieved by dissolving the drug and polymer in a solvent and employing spray-drying to transform the solution.
Benefits include:
- Significantly improved bioavailability of poorly soluble compounds
- Consistent particle size distribution
- Long-term stability
- Increased drug loading capacity
- Potential for taste masking and tailored release dosage profiles: immediate, delayed, and sustained release.
- Tightly controlled and optimized for each compound ensuring consistent quality and performance
- scalability from pilot to full commercial production
- Versatile formulation options: dry powders, granules, or as a part of composite particle system providing flexiblity in downstream processing and dosage form design
Development Capabilities
- Thorough analytical and physical characterization
- Pre-formulation testing, formulation, and process development
- Processing using organic and aqueous solvents to produce particles with optimal stability and absorption characteristics
- Research and development (R&D) and current Good Manufacturing Practice (cGMP) manufacturing capabilities, covering early development to early clinical trial supply (Phase 1 and 2a)
- Downstream processing technologies: granulation, roller compaction, tableting, suspension filling, and packaging.
Late-Phase Spray Drying Capabilities
Renejix ensures a seamless transition and successful tech transfer from early-development sites to strategically located commercial finished dose manufacturing facilities in the U.S.
Key capabilities for late-phase and commercial scale include:
- Formulation and process optimization
- Processing molecules using organic and aqueous solvents
- Integrated teams and streamlined processes for smooth transfer and scale-up
- cGMP manufacturing from Phase 3 to commercial scale
- Flexibility to handle diverse programs, from orphan drugs and pediatric variants to blockbuster products
- A comprehensive range of granulators, blenders, tablet presses, and encapsulators to accommodate various finished dosage forms
Bioavailability Enhancement Solutions
To unlock the full potential of your molecule, we advocate for a rigorous, data-driven screening process that explores the most suitable formulation technologies. At Renejix, we have developed the FormuPhase, a powerful toolkit designed to swiftly and efficiently address the unique requirements of small molecules.
Other bioavailability enhancement technologies include:
- API Salt Form Optimization
- Particle Size Reduction
- Nano-milling
- Hot Melt Extrusion
- Lipid-based Drug Delivery
Related Services
FAQs
Here are some frequently asked questions about Spray Drying
Spray drying is a method used to produce a dry powder from a liquid by rapidly drying with a hot gas. This process involves atomizing the liquid into a fine mist and then exposing it to a flow of hot air, causing the solvent to evaporate quickly and leaving behind dry particles. Spray drying is widely used in the pharmaceutical industry to improve the solubility and bioavailability of drugs, create stable powders for formulation, and enable the production of inhalable aerosols.
Spray drying is important in pharmaceuticals for several reasons:
- Enhances Drug Solubility: Many active pharmaceutical ingredients (APIs) have poor water solubility, which can be improved through spray drying, enhancing their bioavailability.
- Particle Size Control: It allows precise control over particle size and distribution, critical for consistent drug delivery, especially in inhalation therapies.
- Stability: Spray drying can increase the stability of sensitive compounds by rapidly removing moisture and reducing exposure to heat.
- Formulation Flexibility: Enables the production of various dosage forms, including powders, capsules, and tablets, by incorporating excipients during the drying process.
Spray drying can process a wide range of materials, including solutions, suspensions, and emulsions containing APIs, excipients, and other pharmaceutical ingredients. It is suitable for heat-sensitive compounds due to the rapid evaporation of solvent, minimizing thermal degradation. Spray drying can also handle materials that require specific particle characteristics, such as porosity, density, and surface morphology, for targeted drug delivery applications.
Yes, spray drying can significantly improve the bioavailability of drugs. By converting poorly soluble drugs into amorphous solid dispersions with enhanced dissolution rates, spray drying can increase the rate and extent of drug absorption in the body. This process is particularly beneficial for BCS Class II drugs, which have high permeability but low solubility.
Our spray drying services offer comprehensive capabilities, including:
- Development and optimization of spray drying processes tailored to specific API properties and formulation requirements.
- Scalability from pilot-scale batches for feasibility studies and clinical trials to full-scale commercial production.
- Particle engineering to achieve desired particle size, morphology, and physicochemical properties.
- Encapsulation of volatile or sensitive compounds to enhance stability and control release.
- Analytical support for characterizing spray-dried products, including particle size distribution, moisture content, and thermal properties.
We can handle a broad range of spray drying operations, from small-scale pilot projects for early-stage development and clinical trial materials to large-scale commercial production. Our facilities are equipped with state-of-the-art spray dryers that can be adjusted to accommodate different batch sizes, throughput requirements, and product specifications, ensuring flexibility and scalability to meet our clients' needs.
We ensure the quality of spray-dried products through stringent quality control measures and adherence to Good Manufacturing Practices (GMP). This includes:
- Raw material inspection to verify purity and compliance with specifications.
- Process monitoring and control using advanced instrumentation to maintain optimal drying conditions.
- In-process testing to assess critical quality attributes such as moisture content and particle size.
- Final product testing to confirm compliance with all specifications and regulatory requirements.
- Documentation and traceability of all manufacturing and testing activities.
Yes, spray drying can be used to develop controlled release formulations. By encapsulating the API within a matrix of polymer or other excipients that control the release rate of the drug, spray drying can produce particles that release the drug over a desired time frame. This technique is useful for both immediate-release and sustained-release formulations, offering flexibility in drug delivery strategies.
Our spray drying services comply with all relevant regulatory standards, including those set by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation (ICH) guidelines for pharmaceutical manufacturing. We ensure that our processes, equipment, and facilities meet the stringent requirements for GMP compliance, ensuring the highest level of quality and safety for all spray-dried products.
We handle heat-sensitive compounds by optimizing the spray drying process to minimize thermal exposure. This can involve adjusting the inlet and outlet temperatures, feed rate, and atomization parameters to ensure rapid solvent evaporation without compromising the integrity of the heat-sensitive compound. Additionally, we can use cryogenic spray drying or employ protective excipients that encapsulate and shield the compound from heat. Our expertise in process development allows us to tailor the drying conditions to the specific thermal sensitivity of each compound, ensuring its stability and activity.