Novel adhesive hyaluronic acid based solid dosage form for pediatric application
Abstract
The aim of this study was to develop a solid dosage form for pediatric application. For this purpose, hyaluronic acid was covalently linked with sulfhydryl groups of cysteine ethyl ester via amide bond formation mediated by carbodiimide. The obtained hyaluronic acid-cysteine ethyl ester was characterized in terms of degree of substitution, stability, mucoadhesive as well as mucoprotective and lubricative properties. Moreover, toxicity was evaluated on head and neck squamous cells as well as histology assay was performed via alcian blue staining. A novel solid dosage form was prepared and tested for its suitability for pediatric intraoral use. Obtained findings revealed sulfhydryl linked hyaluronic acid was safe to use as no irritation was detected on buccal mucosa. Stability assessment as disintegration and erosion of the matrix could be 12.0-fold and 5.23-fold in presence of hyaluronic acid-cysteine ethyl ester, respectively. The novel designed solid dosage forms provided 3.4-fold augmented lubrication in the intraoral cavity compared to respective hyaluronic acid. In conclusion, the delivery of drugs to children is still an unmet challenge to tackle. This novel excipient for smart dosage forms will pave the pathway for children’s compliance to the next level of therapy.
Conclusion
Since oral route is a preeminently accepted route but fraught with drawbacks of
difficulty in swallowing of tablets and capsules, this study wanted to approach the overcoming of these shortcomings in pediatric adherence. The adherence is so far hampered by discomfort of administration due to size of solid dosage forms. Accordingly, a novel candy shaped solid dosage form based on hyaluronic acid was established in order to evaluate its suitability for intramural application. Dosage forms underwent evaluations and convinced in terms of stability, mucoadhesive and mucoprotective as well as lubricative properties. In concluding remarks, with the usage of these solid dosage forms the pediatric pathway is deliberated from hampered compliance.