Emesis Clinical Trial
Official title:
A New Dual Function Oro-Dissolvable/Dispersible Meclizine HCL Tablet to Challenge Patient Inconvenience: In-Vitro Evaluation and In-Vivo Assessment in Human Volunteers
The main goal of this study is to develop a new oro-dissolvable/dispersible tablet that will augment the dual rapid absorption of MCZ from the buccal cavity as well as prolonging that from the GIT. A dual function tablet is expected to encompass an outer coat of the drug with special excipients that will rapidly disperse and the drug get dissolve and absorb in the buccal cavity and an inner core that will similarly, disperse to release MCZ coated nanoparticles in the saliva. The latter will be subsequently swallowed without water to be absorbed in a prolonged manner from the GIT. This will be advantageous for geriatric as well as pediatric patients, besides, those suffering from dysphagia. The pharmacokinetics profile of the prepared dual function tablet will be assessed in human volunteers through noncompartmental analysis.
The oral route is the most advantageous one for delivering drugs due to patient compliance
and its convenient administration. Fast disintegrating drug delivery systems are those that
disintegrate immediately in the buccal cavity liberating the drug which dissolves or
disperses in the saliva without need of water. The European Pharmacopeia adopted
oro-dispersible tablets (ODT) for a tablet that disintegrate or disperse in less than 60 sec
in the buccal cavity before swallowing. So, the drug dissolution and absorption in addition
to onset of clinical influence and drug bioavailability may be considerably better than those
detected from conventional tablets and capsules. ODTs were initially industrialized to
increase the patient compliance (children, geriatric and bedridden patients).
Nanoparticulate delivery systems have been investigated widely in the pharmaceutical industry
owing to protection from degradation in GIT, the ability to control release of drugs and
improvement of bioavailability.
Meclizine HCL, an antihistamine, has been widely used for prophylactic treatment of nausea,
vomiting and management of dizziness accompanying motion sickness. MCZ is commonly used due
to fewer adverse effects than other antihistaminic drugs but its onset of action is about 1 h
and possesses short half-life. MCZ is a poor water soluble drug and associated with slow rate
of absorption from oral route, therefore, there is a need to improve its dissolution and so
ensure the maximum therapeutic utility. However, many different formulations of MCZ have been
investigated to improve its overall solubility in order to enhance its bioavailability, such
as; complexation with cyclodextrin, preparation of solid dispersions as oro- dispersible
tablets and fast dissolving tablet by sublimation method. Moreover, authors will investigate
the ability of floating microspheres to increase the half-life of MCZ
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