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Pharmaceutical Research For A Orally Disintegrating Tablet For Parkinson;Pharmaceutical Research Of A Pet Medicine

Posted on:2017-03-06Degree:MasterType:Thesis
Country:ChinaCandidate:X JiFull Text:PDF
GTID:2284330503959957Subject:Medicinal chemistry
Abstract/Summary:PDF Full Text Request
Parkinson(PD) is common in the elderly chronic progressive motility disease,the clinical manifestations are bradykinesia, postural reflex disorder, among which the most common are the resting tremor and muscle rigidity. Currently the treatment of Parkinson’s disease mainly relies on drugs, but the drug alone does not prevent disease progression.Currently there are several kinds of drugs on the market for Parkinson, mainly devided into the following three categories: 1. anticholinergic drugs 2. Amantadine 3.levodopa and compound levodopa. This research proposes to study carbidopa and levodopa compound preparation, and the common dosage forms for compound preparations are ordinary tablet, controlled release tablet and water soluble tablet. Our goal is to prepare a orally disintegrating tablet.This article firstly determines the prescription and preparation technology of the compound preparation. The amount of carbidopa and levodopa is obtained by consulting relevant literatures. Through the main drug and excipients compatibility experiment and basic prescription screening, we determine the variety and dosage of the excipients, finally we get the optimal prescription.prescription ratio prescription ratio carbidopa 40% sodium bicarbonate 7%levodopa 4% Anhydrous citric acid 5%MCC 20% magnesium stearate 1%mannitol 16% aerosil 1%PVPP 5% sodium cyclamate 1%Total 100%We preliminaryly determine the high performance liquid chromatography(HPLC)method as a tool of quality detection, and verify the method. Results show that the high performance liquid chromatography(HPLC) method can meet the requirements for main drug content and related substances’ detection. We prepare three batches of tablets, and examine the quality. Results show that the tablet has white and smooth surface, good taste, no sense of gravel. The weight difference is less than ±7.5%,the disintegration time is less than 30 s, the friability is less than 1%, the dissolution rate in 5 minutes is greater than 90%, the main content of medicine is among the labeled amount of 90% ~ 110%. The content of the related substance is less than the loi. The research results show that three batches of tablets’ indexes conform to the requirements of the "Chinese pharmacopoeia" 2015 version.This research on the treatment of Parkinson can provide some experience. The compound preparation is better than a single drug treatment. Orally disintegrating tablet is particularly suitable for patients with Parkinson, and patients who have difficulty in swallowing, so this study is valuable.With the growing pet market, the demand for pet medicine is also growing.Through market research, we found that the most common symptom among pets is arthritis. This may be associated with pets’ less exercise and lying on the cold ground.Meloxicam is a kind of non-steroidal anti-inflammatory analgesic drug(NSAID)which is applicable to rheumatoid arthritis and painful osteoarthritis(arthritis,degenerative osteoarthropathy) symptoms of treatment. Orally disintegrating tablets is a new kind of oral preparation, its main characteristic for us is to take medicines without water or just using a small amount of water, and we doesn’t need to chew,what we have to do is to put them under our tongue surface.when the tablet quickly disintegrate, it can be worked into the stomach by our swallowing. Considering the compliance, convenience, absorption and the fast speed and high biological utilization,this topic decide to develop Meloxicam orally disintegrating tablets.The first part of this research is to introduce the current pet medicine market and mouth collapse related knowledge.The second part is to establish a determination method and make disintegration time as a index for preliminary screening of disintegrating agent.The third part is to determine the prescribe and preparation process. We choose direct compression method as preparation process. We determined the best prescription through single factor experiment and Orthogonal test, combining tablet disintegration time, degree of hardness, brittle broken and taste as the main evaluation:prescription ratio Meloxicam MCC0.17%20%lactose 30%mannitol 42.83%L-HPC 5%magnesium stearate 1%aerosil 1%total 100%The fourth part is to evaluate the qualification of tablets under the best description. Results show that the tablet has white and smooth surface. The weight difference is less than ±7.5%, the hardness is between 3 to 5 kg, the disintegration time is less than 30 s, the friability is less than 1%, the dissolution rate in 5 minutes is85%, the main content of medicine is among the labeled amount of 90% ~ 110%, the content of the related substance is less than the loi, the content uniformity conforms to the requirements.The fifth part studied the stability of Meloxicam orally disintegrating tablets in high temperature, high humidity and strong light environment. Results show that the Meloxicam orally disintegrating tablet under the condition of long-term high temperature, high humidity, illumination is not stable.
Keywords/Search Tags:carbidopa, levodopa, orally disintegrating tablet, disintegration time, orthogonal test, quality evaluation, stability, meloxicam, direct compression method
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