Highly potent but poorly water-soluble drug (PWSD) candidates are common outcomes of drug discovery programs. These lipophilic compounds often exhibit poor systemic exposure following oral administration. Renejix can design Lipid-based formulations that can significantly enhance the absorption of your PWSDs following oral delivery.
Formulation Development
Customized LBDDS Formulations:
- Customizable lipid matrices for optimal drug loading and release kinetics
- Development of nanoemulsions, solid lipid nanoparticles (SLN), and self-emulsifying systems (SEDDS) tailored to your API
- Enhancement of oral bioavailability through lipid-based encapsulation techniques
Analytical Services:
- Detailed physicochemical characterization of lipid formulations
- Robust in vitro-in vivo correlation (IVIVC) studies for predictive modeling of drug release and absorption
- State-of-the-art analytical methodologies including HPLC, NMR, and mass spectrometry
Scalable Manufacturing and Process Optimization:
- GMP-compliant production facilities for clinical and commercial scale-up
- Process optimization for consistent and reproducible batch quality
- Advanced process analytical technology (PAT) for real-time monitoring and control
Technology Platforms
- Ultra-small droplets for superior mucosal penetration
- Enhanced bioavailability and absorption of lipophilic drugs
- Customizable droplet size for targeted delivery applications
Solid Lipid Nanoparticles (SLN):
- Solid matrix provides exceptional control over drug release
- Protection of the active ingredient from degradation
- Suitable for both systemic and localized delivery
Nanostructured Lipid Carriers (NLC):
- Next-generation carriers with improved drug loading capacity
- Structured matrix prevents drug expulsion during storage
- Optimized release profiles for chronic and acute treatment regimens
Self Nano Emulsifying Drug Delivery Systems (SNEDDS):
- Spontaneous emulsion formation in the gastrointestinal tract
- Improved oral bioavailability of poorly water-soluble drugs
- Simplified manufacturing process without the need for high-energy inputs
Advantages
Precise Drug Release: Lipid systems ensure drugs are released at the right time and place, offering controlled and targeted delivery.
Stability: Pharmaceuticals remain stable within these systems, safeguarding their effectiveness over time.
High Drug Content: Compared to other carriers, lipid systems can hold more drug content, enhancing potency.
Versatility: They accommodate both fat-soluble and water-soluble drugs, broadening treatment possibilities.
Body-Friendly: These systems are naturally broken down by the body and are compatible with biological systems, ensuring safety.
Flexible Ingredients: Lipid systems offer versatility in ingredients, allowing customization to suit different drugs and patient needs. These characteristics make lipid-based systems reliable, and effective to provide personalized treatment options for patients.
Related Services
FAQs
Here are some frequently asked questions about Lipid-Based Drug Delivery
- A lipid-based drug delivery system is a method of delivering drugs that uses lipids as carriers. These systems can improve the solubility and absorption of drugs, particularly those that are poorly soluble in water. They can also protect drugs from degradation in the gastrointestinal tract.
- Renejix uses advanced formulation techniques to create lipid-based drug delivery systems that can enhance the bioavailability of poorly water-soluble drugs. These techniques can include the use of liposomes, nanoemulsions, or solid lipid nanoparticles. By encapsulating the drug in a lipid carrier, it can be more easily absorbed in the gastrointestinal tract.
- Renejix uses a variety of lipid excipients in their drug delivery systems, including natural and synthetic lipids. These can include phospholipids, triglycerides, fatty acids, and cholesterol. The choice of lipid excipient depends on the properties of the drug and the desired release profile.
- When formulating a lipid-based oral dosage, Renejix considers factors such as the physicochemical properties of the drug, the desired release profile, the stability of the formulation, and the manufacturability of the dosage form. They also consider the safety and tolerability of the lipid excipients.
Renejix ensures the stability of lipid-based oral dosages through rigorous testing and quality control measures. This can include stability studies under various conditions, as well as testing for physical and chemical stability. They also use appropriate packaging to protect the dosage form from moisture and light.
The manufacturing processes for lipid-based oral dosages at Renejix can include steps such as drug solubilization in the lipid excipient, formation of the lipid-based carrier (such as liposomes or nanoemulsions), and encapsulation or coating of the carrier to form the final dosage form. These processes are carried out under strict quality control to ensure the consistency and quality of the product.
Renejix uses a variety of analytical methods to test the quality of lipid-based oral dosages. These can include methods to measure the size and distribution of the lipid-based carriers, the encapsulation efficiency of the drug, the stability of the formulation, and the release profile of the drug.
Renejix has extensive experience in the scale-up and tech transfer of lipid-based oral dosage forms. They use a systematic approach that includes process optimization, pilot-scale manufacturing, and validation batches. They also work closely with their clients to ensure a smooth tech transfer process.
Regulatory considerations for lipid-based drug delivery systems at Renejix include ensuring compliance with current Good Manufacturing Practices (cGMP), conducting appropriate preclinical and clinical studies to demonstrate the safety and efficacy of the dosage form, and preparing regulatory submissions.
Renejix provides comprehensive support in the development and manufacturing of lipid-based oral dosage forms. This includes formulation development, analytical method development, stability studies, scale-up, tech transfer, and regulatory support. They work closely with their clients to ensure the successful development and commercialization of their products.