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Adherence to medication regimens is a major barrier to effective treatment in many disease areas, notably in dementia which causes cognitive impairment that reduces patients' awareness of non-adherence and their ability to manage medication. The development of oral dosage forms that can be infrequently dosed, and therefore improve adherence rate and facilitate direct observed therapy, has been a goal for decades. We describe the first demonstration of an oral formulation that achieves >7-day gastric retention and sustained pharmacokinetics in the challenging dog model. Gastric retention requires physical resistance of the dosage form to gastric emptying forces, which are known to be stronger in dogs than in humans, making successful gastric retention in dogs a stringent test for predicting human translatability. This formulation of memantine hydrochloride is the first oral dosage form that achieves multi-day drug release with near zero-order kinetics and efficient delivery. In the dog model, relative memantine bioavailability approaches 100% with sustained plasma levels of memantine over seven days and profiles that can be tuned by varying components of the formulation. A single gastric resident dosage form achieves an AUC equivalent to 7 daily treatments with the marketed daily capsule, with a Cmax that is no higher than the daily product. PK modeling predicts that the gastroretentive formulation will maintain therapeutic blood levels in humans when administered once weekly. The formulation methodology presented here is applicable to many water soluble drugs and may enable the development of long-acting oral therapies for a wide variety of conditions.
This article was published in the following journal.
Name: Journal of controlled release : official journal of the Controlled Release Society
Currently, five pharmacotherapeutic options are available to treat Alzheimer's disease: memantine; the three cholinesterase inhibitors donepezil, galantamine, and rivastigmine; and combination treatme...
Clinical trials in Alzheimer disease (AD) generally allow participants to continue receiving concomitant medications, including cholinesterase inhibitors (ChEIs) and memantine, if the dose is stable. ...
Combined vildagliptin and memantine treatment downregulates expression of amyloid precursor protein, and total and phosphorylated tau in a rat model of combined Alzheimer's disease and type 2 diabetes.
There is increasing evidence of a link between type 2 diabetes mellitus (T2DM) and cognitive decline. T2DM has been recognized as a risk factor for Alzheimer's disease (AD). The aim of this research w...
Neurotropic viruses, such as the rabies virus (RABV) and Japanese encephalitis virus (JEV), induce neuronal dysfunction and complication, causing neuronal damage. Currently, there are still no effecti...
To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.
The effects of the medication, memantine, on brain functions and the symptoms of Alzheimer's Disease will be tested
The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD
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About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitat...
Completed forms of the pharmaceutical preparation in which prescribed doses of medication are included. They are designed to resist action by gastric fluids, prevent vomiting and nausea, reduce or alleviate the undesirable taste and smells associated with oral administration, achieve a high concentration of drug at target site, or produce a delayed or long-acting drug effect. They include CAPSULES; LINIMENTS; OINTMENTS; PHARMACEUTICAL SOLUTIONS; POWDERS; TABLETS; etc.
AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.
A colorless to white crystalline compound with a camphoraceous odor and taste. It is a widely used preservative in various pharmaceutical solutions, especially injectables. Also, it is an active ingredient in certain oral sedatives and topical anesthetics.
Vaccines or candidate vaccines used to prevent or treat ALZHEIMER DISEASE.
A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)
Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Dementia describes a range of symptoms of cognitive decline. For example memory loss, problems with reasoning and communication skills, and a reduction in a person's abilities and skills in carrying out daily activities. There are about 820,000 peo...