Product Development Capabilities

• Analytical Services
• Pre-Formulation
• Formulation
• Oral solids ER, IR, DR, Multi-layer, Minitabs, Powder in bottles/Caps, Suspensions, and Long acting injectables
• Pediatric formulations for oral delivery
• Small scale non-GMP and GMP development capability
• Physical characterization
• Controlled substance handling of DEA Schedules I-V
• Clinical supplies testing
• Technology transfer
• Analytical Method Development and Validation
• Method transfer
• On-Site GMP Testing
• On-Site Stability & Storage

Adare’s industry-leading experts possess unparalleled experience in the development of unique patient-centric dosage forms that provide taste masking, customized release, and solubility enhancement capabilities. Our technology platforms address complex formulation challenges to deliver solutions that address the special needs of large patient populations like pediatric, geriatric, and dysphagic patients.

Parvulet® technology is a patient-centric dosage solution that enables a solid powder or tablet to convert to a semi-solid in the presence of water within thirty seconds. The final dosage is easily administered, as a soft food like texture, ideal for pediatric and geriatric populations (including those with dysphagia).

AdvaTab® Orally Disintegrating Tablets (ODTs) incorporates coated or uncoated drug particles that are uniformly dispersed in a low-moisture, rapidly disintegrating matrix. Each ODT is formulated to achieve an acceptable taste and desired release profile. AdvaTab® technology is ideal for patients who have difficulty swallowing, pediatric, geriatric, and dysphagic patients. This technology can be combined with Microcaps® and Diffucaps® to create Immediate release or controlled release ODTs.

Diffucaps® Customized Release Technology with the flexibility to incorporate functional, release-controlling polymers or protective coatings onto drug-layered cores, granules, or crystals. This allows for easy adjustment of both the dosage strength and dissolution profile to achieve the desired in vivo pharmacokinetic profile. Beads can have different release profiles, different active ingredients, or both—all in one product.

Microcaps® Taste Masking and Modified Release Technology that achieves uniform and efficient coating of drug particles by coacervation (phase separation) to build polymeric membranes of varying porosity and thickness. The result is a free-flowing powder containing microencapsulated API (or API substrate) in a wide range of particle sizes. The Microcaps technology can be applied to multiple dosage forms for both immediate and modified-release profiles

MMTSTM Multi Mini Tablet System Customized Release technology combines the simplicity of a tablet formulation with the flexibility of multiparticulate dosage forms with high drug-loading capability. Adare has developed Ultra Microtablets—a smaller standard of tablets targeting diameters in the range of 1.2 mm to even 1.0 mm. The small size facilitates the development of products that can offer multiple drugs or varying release profiles within a single capsule.

DIFFUTAB® technology is an effective solution for targeted drug delivery through customized and sustained release. The technology assists the development of high-dosage and sustained release products for once-daily administration. A matrix tablet is coated with functional polymers, followed by a blend of hydrophilic and hydrophobic polymers. Layered erosion and diffusion of the drug matrix tablet result in a controllable release.

Precision Particle Fabrication™ technology produces uniform microspheres and microcapsules with narrow size distribution and precise control over particle structure. The platform technology is flexible and customizable to accommodate a broad range of active ingredients, including small molecules, peptides, and proteins. The technology uses two physical processes simultaneously to create uniform droplets piezoelectric vibration and a co-flowing non-solvent “carrier” stream. For any given mass flow rate, droplet size can be reduced simply by increasing the frequency of vibration. The technology includes three platforms: Optimμm®, for oral delivery; StratμmTM, for injectable delivery; and Unisun®, for otic delivery.

Optimµm® technology creates microspheres with high drug loading suitable for taste masking, enteric coatings, and extended-release oral applications. The technology is capable of producing single- or double-layer particles in a one manufacturing step, lending to cost-effective creation of palatable dosage forms, which mimic traditional tablets, pills, and capsules. The Optimµm® technology allows for unprecedented control in release rate and dosage form properties. This technology is ideal for oral small molecules, nutraceuticals, agricultural applications, flavorings, and heat stable molecules.

StratµmTM technology, for injectable delivery, allows for precise control of particle size and composition enabling predictable injectable performance, which is critical for self-administration, extended release, and modified release applications with a narrow therapeutic index. Unlike other encapsulation techniques, Stratμm® is capable of producing single- or double-layer particles in a one manufacturing step, lending to creation of next-generation “pulsatile” release formulations or extended-release formulations. This technology is ideal for injectable small molecules, proteins, peptides, vaccines, and heat-labile molecules and requires lyophilization.

Unisun® technology combines the use of encapsulated or free drug, along with a fast-film forming agent, which allows for low-cost, long-acting intratympanic delivery of a therapeutic. The technology allows for less frequent administrations than current therapies and is capable of sustaining drug levels in the inner ear cochlea for weeks. The technology can be used inject and set up highly concentrated depots of a drug and is ideal for small molecules, proteins, peptides, and vaccines.

Adaptdose™, Adare’s unique commercialized approach to adaptive formulation design, is a highly flexible, multi-delivery platform tool that eliminates the need for post Phase 1 trial reformulations and facilitates the creation of custom oral delivery systems. Adaptdose provides the ability to combine 2-3 active ingredients or 3-4 delivery rates in a single capsule using minitablets, granules, and liquid.

Duragran™ allows for more uniformity and precise control of targeted particle sizes while providing production time and cost savings. It eliminates the need for extrusion and spheronization for high API-loaded drug particulates by using fluid bed processing technology that combines the particle sizing and coating processes. This creates controlled-release beads/granules of uniform and narrow particle size range.