Obtaining fast dissolving disintegrating tablets with different doses of melatonin

Area of Science:

• Pharmaceutical Technology
• Pediatric Medicine
• Pharmacology

Background:

• Pediatric patients often face challenges with conventional oral medications.
• Melatonin is used for various conditions in children, including sleep disorders, epilepsy, and Duchenne muscular dystrophy.
• Fast dissolving disintegrating tablets (FDDTs) offer an alternative oral dosage form.

Purpose of the Study:

• To develop and characterize fast dissolving disintegrating tablets (FDDTs) of melatonin for pediatric use.
• To formulate FDDTs with different dosages (3, 5, 10, and 60 mg) suitable for specific pediatric indications.
• To evaluate the feasibility of direct compression and effervescent formulations for pediatric FDDTs.

Main Methods:

• Manufacturing of FDDTs using direct compression and effervescent excipients.
• Characterization of tablet properties including disintegration time, hardness, and friability.
• Dosage formulation tailored for pediatric conditions like epilepsy, sleep disorders, and Duchenne muscular dystrophy.

Main Results:

• Tablets achieved disintegration times under 25 seconds.
• Manufactured tablets exhibited acceptable hardness and friability, indicating no special storage requirements.
• Two distinct FDDT formulations were successfully developed, one for direct compression and another with effervescent properties.

Conclusions:

• FDDTs provide a viable and patient-friendly alternative for pediatric melatonin administration.
• The developed melatonin FDDTs meet critical quality attributes for ease of use and stability in pediatric populations.
• These formulations are suitable for various pediatric conditions requiring melatonin, including neurological and neuromuscular disorders.