International Journal of Pharmaceutical Investigation, 2022, 12, 3, 323-327.
DOI: 10.5530/ijpi.2022.3.54
Published: July 2022
Type: Original Article
Authors:
Manjunath Pobbathi Nagaraj
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), At Po Pipariya, Waghodia, Vadodara, Gujarat, INDIA.
Avinash Kumar Seth
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), At Po Pipariya, Waghodia, Vadodara, Gujarat, INDIA.
Anand Kandkere Ravindra Kumar
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), At Po Pipariya, Waghodia, Vadodara, Gujarat, INDIA.
Vivekanandan Sundaramurthy
Product Development, Bluefish Pharmaceuticals Private Limited, Bangalore, Karnataka, INDIA.
ABSTRACT
Background: Circadian rhythms is a natural process that regulates the sleep wake cycle which is associated with several physiological, biochemical, endocrine, behavioural processes in humans and entrainment to light-dark cycle. The activity of Ramelteon is believed to contribute to its sleep-promoting properties and thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle. A tablet can be given before 2 hr of bed time, so the Ramelteon drug shows its effect throughout the night by releasing the active content with lag time followed by sustained action to promote the sleep. Materials and Methods: Chronotherapeutic drug delivery system were prepared by compression coating technology using pH independent, hydrophilic and hydrophobic polymers. Results: Drug excipient compatibility indicated that the Ramelteon Active pharmaceutical ingredient (API) is compatibility with the excipients proposed. The X-ray Diffraction (XRD) studies indicated that the crystalline form of the Ramelteon API existed in the finished formulation. Conclusion: The core tablets containing Eudragit RSPO 10mg/tablet and ratio of Ethyl cellulose: Hydroxy propyl methyl cellulose (HPMC) of 70:30 in the outer coating material yielded a desired lag time of 2 hr and drug release for a period of 4 hr to achieve a chronotherapeutic drug delivery system. Ramelteon is an excellent candidate in designing chronotherapeutic drug delivery systems and further in vivo studies can be explored in the treatment of circadian rhythm with sleep wake cycle disorders.
Keywords: Ramelteon, Compression coated, Sleep disorders, Jet lag phase, Sleep wake cycle, Eudragit.