Formulation Technology Platforms
Renejix Pharma Solutions has unrivaled expertise in formulation technologies for complex oral solid and liquid dosage forms. We use a wide range of advanced formulation technologies to increase bioavailability or achieve controlled release for even the most challenging APIs. We have developed new formulation technologies and optimized existing products, including oral solid dose (OSD), solutions, oral dissolving films (ODFs) suspensions, and topicals.
DEEP EXPERTISE: Our broad expertise and superior formulation technologies have helped move dozens of molecules from the early stages of development through to commercialization. With staff members having 30+ years of experience in formulation development and formulation technology selection, Renejix will partner with you to select the best technology for your molecule.
VERSATILE DELIVERY: We have worked with hundreds of molecules with different delivery profiles and accelerated timelines. With a wide range of oral delivery formulation technologies, we can help advance your molecule to the next phase of development faster and improve clinical efficacy.
CONTROLLED RELEASE
Microencapsulation
MULTIPARTICULATE
aMORPHOUS sOLID dISPERSIONS
ORALLY DISINTEGRATING TABLETS
ABUSE DETERRENT
Taste-MAsking
BIOAVAILABILITY ENHANCEMENT
LIPID bASED dRUG dELIVERY
Nanoparticles
Nanocrystals
Polymeric Nanoparticles
LIPID NANOPARTICLES (LNP)
Solid Lipid Nanoparticles
Nanostructured Lipid Carriers
Nanoemulsions
Self-Emulsifying Drug Delivery Systems
Overview
CONTROLLED RELEASE
Controlled release formulations are designed to deliver the drug at a predetermined rate, prolonging the therapeutic effect and improving patient compliance. Our technologies enable the creation of dosage forms that release the active ingredient slowly over time, reducing the frequency of dosing.
MICROENCAPSULATION
Microencapsulation technology allows us to encase tiny particles or droplets of active ingredients within a protective coating. This technique is ideal for protecting sensitive compounds from degradation, controlling release rates, and masking unpleasant tastes.
MULTIPARTICULATE
Multiparticulate systems consist of multiple small particles, each with a potential benefit of providing uniform distribution of the drug throughout the gastrointestinal tract, reducing the risk of local irritation and improving patient compliance.
AMORPHOUS SOLID DISPERSIONS
Amorphous solid dispersions involve dispersing a poorly soluble drug in a polymer matrix to enhance its solubility and bioavailability. This technology is crucial for drugs with low aqueous solubility, a common hurdle in drug formulation.
ORALLY DISINTEGRATING TABLETS
Orally disintegrating tablets (ODTs) dissolve or disintegrate rapidly in the mouth without the need for water. Our ODT technology provides an excellent option for patients who have difficulty swallowing conventional tablets or capsules.
ABUSE DETERRENT
Abuse-deterrent formulations are developed to prevent the misuse and abuse of controlled substances. Our technologies include physical and chemical barriers that resist tampering and reduce the potential for abuse.
TASTE-MASKING
Taste-masking technologies are employed to improve the palatability of oral medications. By using various coating materials and techniques, we can effectively mask the unpleasant taste of active pharmaceutical ingredients.
BIOAVAILABILITY ENHANCEMENT
Our bioavailability enhancement technologies address the challenge of low drug solubility and permeability. Techniques such as particle size reduction, solubilizers, and permeation enhancers are used to improve the rate and extent of drug absorption. Utilizing advanced formulation technologies like micronization and nanoparticle formulation, we enhance the bioavailability and stability of drug compound as well.
LIPID BASED DRUG DELIVERY
Lipid-based drug delivery systems utilize lipids to improve the solubility and bioavailability of poorly water-soluble drugs. These systems can take various forms, including liposomes, emulsions, and lipid complexes.
NANOPARTICLES
Nanoparticles, including nanocrystals and polymeric nanoparticles, offer a significant advantage in drug delivery by enhancing drug solubility, stability, and targeting specific tissues or cells.
NANOCRYSTALS
Nanocrystals are pure drug particles that are formulated into nanometer size to improve their dissolution rate and bioavailability. This technology is particularly beneficial for drugs with poor water solubility.
POLYMERIC NANOPARTICLES
Polymeric nanoparticles are submicron-sized particles where the drug is encapsulated, adsorbed, or dissolved within a polymer matrix. They are used for controlled drug release and targeted drug delivery.
SOLID LIPID NANOPARTICLES & NANOSTRUCTURED LIPID CARRIERS
Solid lipid nanoparticles and nanostructured lipid carriers are advanced lipid-based nanocarriers that enhance the solubility, stability, and bioavailability of lipophilic drugs.
NANOEMULSIONS
Nanoemulsions are fine oil-in-water or water-in-oil emulsions with droplet sizes in the nanometer range. They are known for their improved drug solubility and bioavailability.
SELF-EMULSIFYING DRUG DELIVERY SYSTEMS
Self-emulsifying drug delivery systems are mixtures of oils and surfactants that form fine oil-in-water emulsions when exposed to gastrointestinal fluids. This technology enhances the oral bioavailability of hydrophobic drugs.
Bioavailability Enhancement
Particle Size Reduction Technologies We employ particle size reduction technologies like nanomilling and high-pressure homogenization to enhance the dissolution and absorption rates of drugs. This is a critical step in bioavailability enhancement, especially for drugs that require a significant increase in surface area to become more effective.
Lipid-Based Formulation Technologies Our lipid-based formulations, including self-emulsifying drug delivery systems (SEDDS), are part of our innovative bioavailability enhancement toolkit. These systems are particularly effective for poorly water-soluble drugs, improving their absorption and ensuring they reach their therapeutic destination.
Prodrug Design Our expertise in prodrug design allows us to improve the solubility, permeability, and bioavailability of challenging drugs. By converting these compounds into prodrugs, we ensure they are metabolized into their active forms more efficiently, enhancing their overall effectiveness.
Solid-State Alteration Techniques We utilize solid-state alteration techniques, such as co-crystallization and solid-state amorphization, to positively impact the solubility and bioavailability of drugs.
Drug Conjugates Our development of drug conjugates is another way we enhance pharmacokinetic properties. By linking drugs to molecules like polymers or antibodies, we improve their stability, solubility, and targeting ability, ensuring that patients receive the most effective treatments available.
Nanotechnology and Advanced Materials We use the power of nanotechnology and advanced materials to provide targeted delivery and improved absorption of drugs, setting new standards in the effectiveness of drug delivery systems.
CONTROLLED RELEASE
Controlled release formulations are designed to deliver the drug at a predetermined rate, prolonging the therapeutic effect and improving patient compliance. Our technologies enable the creation of dosage forms that release the active ingredient slowly over time, reducing the frequency of dosing.
MICROENCAPSULATION
Microencapsulation technology allows us to encase tiny particles or droplets of active ingredients within a protective coating. This technique is ideal for protecting sensitive compounds from degradation, controlling release rates, and masking unpleasant tastes.
MULTIPARTICULATE
Multiparticulate systems consist of multiple small particles, each with a potential benefit of providing uniform distribution of the drug throughout the gastrointestinal tract, reducing the risk of local irritation and improving patient compliance.
AMORPHOUS SOLID DISPERSIONS
Amorphous solid dispersions involve dispersing a poorly soluble drug in a polymer matrix to enhance its solubility and bioavailability. This technology is crucial for drugs with low aqueous solubility, a common hurdle in drug formulation.
ORALLY DISINTEGRATING TABLETS
Orally disintegrating tablets (ODTs) dissolve or disintegrate rapidly in the mouth without the need for water. Our ODT technology provides an excellent option for patients who have difficulty swallowing conventional tablets or capsules.
ABUSE DETERRENT
Abuse-deterrent formulations are developed to prevent the misuse and abuse of controlled substances. Our technologies include physical and chemical barriers that resist tampering and reduce the potential for abuse.
TASTE-MASKING
Taste-masking technologies are employed to improve the palatability of oral medications. By using various coating materials and techniques, we can effectively mask the unpleasant taste of active pharmaceutical ingredients.
BIOAVAILABILITY ENHANCEMENT
Our bioavailability enhancement technologies address the challenge of low drug solubility and permeability. Techniques such as particle size reduction, solubilizers, and permeation enhancers are used to improve the rate and extent of drug absorption. Utilizing advanced formulation technologies like micronization and nanoparticle formulation, we enhance the bioavailability and stability of drug compound as well.
LIPID BASED DRUG DELIVERY
Lipid-based drug delivery systems utilize lipids to improve the solubility and bioavailability of poorly water-soluble drugs. These systems can take various forms, including liposomes, emulsions, and lipid complexes.
NANOPARTICLES
Nanoparticles, including nanocrystals and polymeric nanoparticles, offer a significant advantage in drug delivery by enhancing drug solubility, stability, and targeting specific tissues or cells.
NANOCRYSTALS
Nanocrystals are pure drug particles that are formulated into nanometer size to improve their dissolution rate and bioavailability. This technology is particularly beneficial for drugs with poor water solubility.
POLYMERIC NANOPARTICLES
Polymeric nanoparticles are submicron-sized particles where the drug is encapsulated, adsorbed, or dissolved within a polymer matrix. They are used for controlled drug release and targeted drug delivery.
SOLID LIPID NANOPARTICLES & NANOSTRUCTURED LIPID CARRIERS
Solid lipid nanoparticles and nanostructured lipid carriers are advanced lipid-based nanocarriers that enhance the solubility, stability, and bioavailability of lipophilic drugs.
NANOEMULSIONS
Nanoemulsions are fine oil-in-water or water-in-oil emulsions with droplet sizes in the nanometer range. They are known for their improved drug solubility and bioavailability.
SELF-EMULSIFYING DRUG DELIVERY SYSTEMS
Self-emulsifying drug delivery systems are mixtures of oils and surfactants that form fine oil-in-water emulsions when exposed to gastrointestinal fluids. This technology enhances the oral bioavailability of hydrophobic drugs.
Particle Size Reduction Technologies We employ particle size reduction technologies like nanomilling and high-pressure homogenization to enhance the dissolution and absorption rates of drugs. This is a critical step in bioavailability enhancement, especially for drugs that require a significant increase in surface area to become more effective.
Lipid-Based Formulation Technologies Our lipid-based formulations, including self-emulsifying drug delivery systems (SEDDS), are part of our innovative bioavailability enhancement toolkit. These systems are particularly effective for poorly water-soluble drugs, improving their absorption and ensuring they reach their therapeutic destination.
Prodrug Design Our expertise in prodrug design allows us to improve the solubility, permeability, and bioavailability of challenging drugs. By converting these compounds into prodrugs, we ensure they are metabolized into their active forms more efficiently, enhancing their overall effectiveness.
Solid-State Alteration Techniques We utilize solid-state alteration techniques, such as co-crystallization and solid-state amorphization, to positively impact the solubility and bioavailability of drugs.
Drug Conjugates Our development of drug conjugates is another way we enhance pharmacokinetic properties. By linking drugs to molecules like polymers or antibodies, we improve their stability, solubility, and targeting ability, ensuring that patients receive the most effective treatments available.
Nanotechnology and Advanced Materials We use the power of nanotechnology and advanced materials to provide targeted delivery and improved absorption of drugs, setting new standards in the effectiveness of drug delivery systems.
FAQs
Here are some frequently asked questions about Formulation Technologies
Formulation technology solutions involve the process of designing and developing the composition of a drug product, including the active pharmaceutical ingredient (API) and other non-active components, to ensure it is safe, effective, and stable.
This process is critical for pharmaceutical development as it directly impacts the drug's performance, patient compliance, and shelf-life. Effective formulation can improve the bioavailability of a drug, enhance its stability, and provide controlled release profiles, ensuring optimal therapeutic outcomes.
Renejix approaches new drug formulation development through a systematic process that includes:
- Pre-formulation studies: Characterizing the physical and chemical properties of the API to inform formulation strategy.
- Formulation design: Selecting appropriate excipients and designing the formulation to meet the desired product profile.
- Prototype development: Creating laboratory-scale batches for initial testing.
- Process development: Optimizing the manufacturing process for scalability and reproducibility.
- Stability testing: Assessing the formulation's stability under various conditions to predict its shelf life.
- Regulatory support: Ensuring the formulation meets all regulatory requirements for safety and efficacy.
Selecting excipients involves considering several key factors:
- Compatibility with the API: Excipients must not interact adversely with the API, affecting its stability or efficacy.
- Functional properties: The excipient should provide the desired functionality, such as enhancing solubility, providing controlled release, or improving taste.
- Safety profile: Excipients must be safe for the intended route of administration and patient population.
- Regulatory status: Excipients should be acceptable to regulatory authorities and comply with relevant guidelines.
- Manufacturability and cost: Considerations include the ease of sourcing, handling, and cost-effectiveness.
Scalability of drug formulations is a critical consideration for CDMOs, involving:
- Process optimization: Developing manufacturing processes that are efficient and scalable, from laboratory to commercial scale.
- Equipment selection: Utilizing flexible and scalable equipment that can accommodate different batch sizes.
- Quality control: Implementing robust quality control measures that ensure consistent product quality across all scales.
- Regulatory compliance: Ensuring that the scaled-up process and formulation meet all regulatory requirements for manufacturing and quality assurance.
Yes, Renejix can assist in enhancing the bioavailability of poorly soluble drugs through various formulation strategies and technologies, such as:
- Nanotechnology-based formulations: Reducing particle size to nanoscale to improve dissolution rates.
- Solid dispersions: Using polymers to disperse the drug in a solid matrix, enhancing solubility.
- Lipid-based delivery systems: Formulating the drug in lipid carriers to enhance intestinal absorption.
- Self-emulsifying drug delivery systems (SEDDS): Creating formulations that form emulsions in the gastrointestinal tract to improve solubility and absorption.
Stability studies are crucial in formulation development as they:
- Determine shelf life: Assess how long the drug product maintains its identity, strength, quality, and purity.
- Inform packaging: Identify appropriate packaging materials to protect the product from environmental factors.
- Guide storage conditions: Establish optimal storage conditions to maintain product stability.
- Regulatory requirement: Provide necessary data for regulatory submissions, demonstrating the product's stability over its intended shelf life.
CDMOs ensure regulatory compliance in formulation development by:
- Following guidelines: Adhering to current Good Manufacturing Practices (cGMP) and relevant guidelines from regulatory bodies like the FDA and EMA.
- Documentation: Maintaining comprehensive records of formulation development and manufacturing processes.
- Quality control and assurance: Implementing rigorous quality control and assurance procedures throughout development and manufacturing.
- Regulatory expertise: Employing experts who are familiar with regulatory requirements in various markets to guide formulation development and submission strategies.
Yes, CDMOs can provide controlled release formulations using various technologies and approaches, such as:
- Coatings: Applying polymer coatings to tablets or granules to control drug release rates.
- Matrix systems: Embedding the drug in a matrix that slowly dissolves or erodes, controlling the release.
- Microencapsulation: Encapsulating the drug in microspheres or microcapsules to achieve delayed or sustained release.
- Lipid formulations: Using lipids to modulate the release of the drug.
For pediatric and geriatric-friendly formulations, Renejix uses technologies such as:
- Mini-tablets and microtablets: Small-sized tablets that are easier to swallow.
- Orally disintegrating tablets (ODTs): Tablets that dissolve rapidly in the mouth, eliminating the need for water.
- Taste masking: Techniques to improve the palatability of oral medicines.
- Flexible dosing: Formulations that allow dose adjustments to meet individual patient needs.