age forms that emphasize patient convenience and meeting the specific needs of pediatric and geriatric populations are creating more demand for coating solutions. The ability of specially designed coatings to provide both taste-masking and controlled-release functionalities is driving interest in their use for reformulation of oral solid dosage products that are losing patent protection. In particular, as more products leverage ODT, multiparticulate, sprinkle, and other formats that enable differentiation but require prevention of exposure of the API in the mouth, film coatings are becoming more widely used.

Matching the Formulation to the API Properties and the Patient Population

Ultimately, a balance must be achieved in terms of swallowability, taste, and palatability, including mouthfeel and texture. Decisions must be made on a project-by-project basis considering the nature of the API, the desired dosage form, and the target patient population.

While liquid formulations are ideal for patients with swallowability issues, the API might not be stable in a liquid solution or suspension. In addition, taste may be a challenge if it is a high-dosage product with an extremely bitter API. A chewable product with appropriate taste-masking technology may be a better solution. Of course, more complicated platforms involve longer development timelines and often higher costs, which also must be factored into the decision-making process.

Supporting Specialized Formulations with a Multitude of Solutions

Mikart is a CDMO offering support for formulation development and manufacturing of patient-centric pediatric and geriatric drug products that address swallowing, taste, and palatability concerns. We have expertise in both liquid solutions and suspensions, having recently brought onstream a new liquids manufacturing area that can handle both standard liquids and suspensions.

In addition, Mikart has established capabilities in multiparticulates, minitablets, sprinkle formats, ODTs, and chewable and sublingual tablets, among other dosage forms, as well as aqueous-based coating and other taste-masking and controlled-release technologies. We can produce complexes, including those based on ion-exchange resins and incorporate them into several dosage platforms.

Complementing these offerings is Mikart’s ability to package drug products in high-density polyethylene and glass bottles for liquids, solids, and powders for reconstitutable solutions and suspensions. We also have a liquid filler machine that can be used to fill unit-dose cups and sachets. Other packaging solutions include both cold-form and thermoform blisters that enable the production of products in child-resistant packaging that can still be opened by elderly patients.

Mikart can support customers that have a chosen platform and are seeking direct tech transfer and manufacturing support, as well as customers looking for guidance regarding the optimum platforms for their APIs and target patient populations. For the latter group, we have a small non-GMP laboratory set up to support feasibility studies via rapid screening of multiple platforms.

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