Pharmaceutical Research On Two New Products For Dogs

With the rapid increase in the number of pet dogs in China,the demand for canine drugs continues to grow.The oral canine drugs which are convenient administration,high acceptance degree and low prices can not meet the needs of the domestic market.The study is to prepare orally disintegrating tablets(ODTs)of mosapride citrate for dogs.The main contents include the following chapters:The content of the second chapter was to prepare orally disintegrating tablets(ODTs)of mosapride citrate for dogs with fast disintegration and low cost.The properties of the ODTs,including hardness,friability,active ingredient content,and in vitro disintegration time,were investigated,and an economic analysis of the formulations was performed.Results showed that Formulation(F)2,containing 5% sodium carboxymethyl starch;F3,containing 5% low-substituted hydroxypropylcell ulose;and F5 had not only shorter disintegration times but also lower costs,which were suitable for mosapride citrate ODTs.Results also revealed that the disintegration time of F5 was not significantly different from those of F1,F2,F3,and F4(p>0.05),all of which contained superdisintegrants.Without superdisintegrants,F5,which contained a mixture of microcrystalline cellulose,mannitol,and lactose,was also able to achieve a short disintegration time and to meet the requirements of ODTs for dogs.Under the synthetical consideration,choose the F2 as the final formulation of mosapride citrate ODTs.In the third chapter,study the quality standard and get a scientific and reasonable quality standard draft.The fourth chapter is concerned the stability study of mosapride citrate ODTs.By the influencing factors test,accelerated test and long-term test,we can grasp the rule of its quality change with time and provide the basis for determining the packaging materials and storage conditions.The results showed that mosapride citrate ODTs were sensitive to high temperature and high humidity.It should pay attention to moisture and be in sealed package at a cool and dry place.In the fifth chapter,the acceptance test of citrate mosapride ODTs was designed for dogs.30 privately owned dogs of 8 breeds were included,which were six months to twelve years old,and a weight range of 2.5 to 40 kg.The acceptance test was based on a cross-over design and used conventional tablets as control.The results showed that 80.8%(n=120)of dogs consumed ODTs of mosapride citrate,and 25.8%(n=120)of dogs consumed conventional tablets,which had significantly different between them(p<0.05).The new dosage form showed a high acceptability compared to the conventional tablets,which was prerequisite for accelerating gastrointestinal motility.In a word,the mosapride citrate ODTs for dogs were rapid disintegration,low cost,reliable quality,high acceptability,which were a kind of new tablets for dogs.Sustained release preparation is an important new dosage form for dogs.Oral sustained release preparation can reduce the administration times and total dose,decrease the side effects and save the treatment cost.More important is convenient administration,especially for chronic diseases.The sustained release preparation can improve the dogs' compliance and the hosts' acceptance.The traditional sustained release tablets,either the skeleton type or the membrane controlled type,will be affected on the sustained release effect because of the dogs' chewing.The granule size of sustained release granules is small,and they are not easy to be affected by dogs' chewing and gastric emptying,but they are not convenient to be administrated.Compressing sustained release granules into orally disintegrating tablets(ODTs)not only solve the problem of inconvenient administration of the sustained release granules,but also avoid the influence on the sustained release effect by dogs' chewing,which is a more suitable oral sustained release dosage form for dogs.The study was to prepare sustained release orally disintegrating tablets(SR-ODTs)of norfloxacin lactate for dogs,which pressed sustained release granules of norfloxacin into oral disintegrating tablets.The main contents include the following chapters:In the second chapter,screen the optimal formulation of norfloxacin sustained release granules.The release rate as the index,the skeleton material,sieve mesh,binder were selected by the single factor test,then optimal formulation was screened by the orthogonal test and was verified.The results showed that the release rate of sustained release granules prepared by HPMC K4 M and HPMC K15 M as skeleton materials basically reached the requirements,and the preparation method was simple;the sieve mesh was 12;the binder was 1% CMC-Na.The optimal formulation screened by the orthogonal test was 20% HPMC K15 M as skeleton materials,starch as fillers.The release rate of the optimal formulation at 2,6,12 h was 31.23%,51.44% and 86.91%,respectively.The optimal formulation of norfloxacin sustained release granules was reasonable and met the requirements of release in vitro.The third chapter was to compress sustained release granules of norfloxacin into ODTs with fast disintegration and qualified release.The properties of the SR-ODTs including friability,hardness,in vitro disintegration time,release rate and so on were investigated.The disintegration time of F2(CMS-Na)?F3(L-HPC)and F4(PVPP)were about 30 s and there were no significant difference between them(p>0.05).The release curves of F1,F2,F3 and F4 were similar,and there were no significant difference(50?f2?100).Considering the properties of the ODTs and the sustained release effect,the cheap F2 was the best formulation for the norfloxacin SR-ODTs of dogs.The optimized formulation F2 comprised 50% norfloxacin sustained release granules,40% ordinary granules,7% sodium carboxymethyl starch,and 3% magnesium stearate.The reproducibility test showed good results.The release curves of norfloxacin sustained-release granules and SR-ODTs were compared,and there were no significant difference(50?f2?100).In the fourth chapter,study the quality standard and get a scientific and reasonable quality standard draft.The fifth chapter was concerned the stability study of norfloxacin SR-ODTs.By the influencing factors test,accelerated test and long-term test,we can grasp the rule of its quality change with time and provide the basis for determining the packaging materials and storage conditions.The results showed that norfloxacin SR-ODTs were sensitive to humidity and easy to absorb moisture.It should be in sealed package at a dry storage.In a word,the norfloxacin SR-ODTs for dogs were rapid disintegration,qualified in vitro release and reliable quality,which were a kind of new tablets for dogs.