Chewable formulations with MCC starter cores: Patient-centric design and pharmaceutical relevance

Chewable formulations with MCC starter cores are an advanced oral dosage form that combines patient-friendly administration with robust pharmaceutical performance. Thereby, patient refers includes humans and non-human mammalian animals, such as dogs, cats, mice, rats, guinea pigs, rabbits, ferrets, cows, horses, sheep, goats, and pigs. At the outset, these formulations address a key challenge in drug therapy, namely patient compliance, by offering a dosage form that patients can chew without water. Consequently, they are particularly suitable for pediatric, geriatric, and veterinary applications. Moreover, chewable dosage forms allow formulators to improve taste, mouthfeel, and ease of use, which directly supports adherence to therapy. At the same time, MCC starter cores provide excellent mechanical stability, uniformity, and processing reliability. Therefore, they enable consistent drug loading, predictable disintegration, and scalable manufacturing. As a result, this combination creates significant opportunities for modern, patient-centric drug delivery.

Chewable formulations with MCC starter cores according to WO2022049149A1

The patent WO2022049149A1 describes chewable pharmaceutical compositions designed to disintegrate rapidly while maintaining acceptable texture and stability. In particular, the invention focuses on soft chewable dosage forms that contain at least one active pharmaceutical ingredient together with carbonate or bicarbonate compounds that act as efficient disintegrants. As a result, the dosage form breaks down quickly when exposed to aqueous or gastric media. This rapid disintegration directly supports fast and reproducible dissolution of the API. Furthermore, the patent emphasizes that surface structure, porosity, and wettability of the chewable matrix strongly influence drug release. Therefore, careful control of formulation and processing parameters becomes essential. The disclosed chewable products typically achieve disintegration within pharmacopeial limits and release a high proportion of the API within short dissolution times. In addition, the patent highlights the importance of balancing lipophilic excipients, since excessive hydrophobicity can delay disintegration. Consequently, the invention aims to deliver chewable dosage forms that combine good palatability with reliable pharmaceutical performance. Overall, the patent demonstrates how optimized excipient systems can overcome common limitations of chewable drugs while improving patient acceptance.

Advances, dissolution considerations, and API challenges in chewable dosage forms

Chewable formulations with MCC starter cores illustrate clear advances in chewable drug technology. First, the use of spherical MCC cores supports multiparticulate designs that improve content uniformity and process robustness. Moreover, these cores enable precise API layering, which enhances dose accuracy and reproducibility. When considering dissolution profiles, formulators must carefully manage core porosity, disintegrant efficiency, and wettability. Therefore, rapid liquid penetration and controlled matrix breakdown remain critical success factors. At the same time, APIs in chewable formulations face both obstacles and opportunities. On one hand, taste masking, stability, and dissolution control present technical challenges. On the other hand, chewable formats open new possibilities for poorly compliant patient groups and combination therapies. Consequently, successful products require a well-balanced formulation strategy that aligns API properties with excipient functionality.

Role of CELLETS® in the context of this patent

Although WO2022049149A1 does not explicitly name commercial products, its technical concept strongly aligns with MCC starter cores such as CELLETS® 100 (100-200 µm) and CELLETS® 200 (200-355 µm). These microcrystalline cellulose spheres offer high sphericity, low friability, and narrow particle size distribution. Therefore, they provide an ideal substrate for API layering in chewable multiparticulate systems. CELLETS® 100 and CELLETS® 200 support uniform coating, predictable dissolution behavior, and efficient processing in fluidized bed systems. In addition, their inert and tasteless nature helps minimize interactions with APIs and flavoring agents. As a result, they play a crucial functional role in achieving stable, reproducible, and patient-acceptable chewable formulations.

Conclusion and outlook for chewable formulations with MCC starter cores

Chewable formulations with MCC starter cores represent a strategic convergence of patient-centric design and pharmaceutical engineering. In conclusion, the integration of MCC starter cores enhances manufacturing reliability, dose uniformity, and dissolution performance while supporting improved patient compliance. Moreover, patents such as WO2022049149A1 demonstrate how modern excipient systems can overcome traditional limitations of chewable dosage forms. Looking ahead, further innovation will likely focus on advanced taste-masking technologies, tailored dissolution profiles, and broader API compatibility. Therefore, chewable formulations with MCC starter cores are well positioned to play an increasingly important role in future oral drug delivery.

Patent Summary

• Name of Patent: Chewable formulations
• Patent Number: WO2022049149A1
• Year of Patent: 2021
• Patent Holders: Clément Maxime Chevreau, Pascal Grenier, Claudia Reitz
• Affiliation: Elanco Tiergesundheit AG