Oral Solid Doses
LLS Health has experience partnering with our clients to develop unique formulations, including oral solid dosage forms (OSD).
We offer an extensive excipient portfolio coupled with trusted formulation and manufacturing expertise. Our customer-focused staff utilizes a number of technologies to accelerate your product to market and introduce critical properties such as controlled release and improved bioavailability.
LLS Health has a comprehensive understanding of the elements that comprise an oral drug product. Drug developers are placing increased focus on excipients, driven by factors such as regulatory demands, global supply chain scrutiny, and high-potency APIs which require functional excipients.
Lubrizol’s excipients are highly-efficient gel matrix formers used to control pharmaceutical drug delivery and release in tablets, capsules, and multi-particulate systems. Our controlled release polymers have demonstrated slower release rates at lower concentrations than other commercially available pharmaceutical excipients, enabling overall formulation cost savings and smaller tablet sizes.
Our Carbopol® excipients are widely compatible with other inactive ingredients and can be used alone or in combination to achieve a desired release profile. These polymers are available in both powder and granular forms, and therefore can be used in all types of tablet manufacturing processes. Carbopol has also been shown to aid in taste masking, tablet binding or coating, and mucoadhesion.
Nanomilling and nanoparticle formulation is at the forefront of much of our CDMO work. Particle size reduction via nanomilling improves bioavailability by increasing the surface area of API molecules, resulting in faster dissolution. Numerous BCS class II and IV APIs have benefited from this technology and 10+ nanomilled drug products have gained FDA approval since 2000, including multiple OSD products. This process also has the added benefits of:
- No harsh organic solvents or pH extremes
- High API concentrations
- Scalability and reproducibility
Hot melt extrusion
Hot melt extrusion (HME) is a core strength for us at LLS Health and we can work with you to evaluate if this process is well-suited for your product. Our team has extruded products containing the most challenging APIs, including highly potent compounds and controlled substances. HME offers many advantages for complex OSD drug development, including:
- Enhanced bioavailability of poorly soluble compounds
- Reduced production time, fewer processing steps, and continuous operation
- Compatibility with other sustained, modified, and targeted release components
Our formulation team employs a data-driven approach to find solutions for even the most challenging APIs employing a range of technologies to maximize bioavailability, control release rate, and enhance stability. Our scientists work on projects from early-stage development through scale-up and transition to our clinical and commercial manufacturing teams.
We offer GMP manufacturing for many dosage forms, and our integrated approach creates a smooth transition from pre-clinical activities through clinical validation. We have GMP manufacturing space that is supported by in-house analytical services, bioanalytical services, physicochemical characterization, and ICH-compliant stability programs.
We have over two decades of experience developing and validating release assays for a variety of drug products, including semi-solid formulations, implantable devices, and oral solid dosage forms. Our GMP/GLP facilities are equipped with specialized equipment and seasoned analytical scientists who perform both routine and custom drug release testing.