Pharmaceutical Excipients Industrial Production Of Maltodextrin

Medicinal Maltodextrin is a novel and basic pharmaceutical excipients with lowsweetness, low calorie and highly nutritious. Its function and application is veryextensive. It is mainly used in food industry, pharmaceutical industry and other fields.Because medicinal maltodextrin is used widely and studied deeply, it is expected thatthere will be a good economic and social benefits. In this paper, the production ofpharmaceutical excipients process was discussed, the products for the stability testsand compatibility tests was also done. After rigorous testing of the final product, it wasproved that maltodextrin products all accorded with the relevant indicator of ChinesePharmacopoeia and Pharmaceutical excipients maltodextrin quality standard (draft).The results showed Medicinal Maltodextrin products were safe, effective, and theirquality was controllable.1. After the high temperature type of α-amylase of maltodextrin production test inseveral small scale laboratory experiments, Ultimately we determined the parametersof pharmaceutical excipients maltodextrin test in lab process: optimum pH value of5.5to6.0, the reaction temperature of95℃, reaction time of60min, and amylase13500U/tonne of starch.2. Based on determined the parameters of small scale laboratory production ofmaltodextrin, after a long time research and experiments for the workshop productionof medicinal maltodextrin, we ultimately determined the workshop production processand critical control parameters of medicinal maltodextrin. Then, we trial-producedthree batches of each50tons of total feeding amount of maltodextrin sample (batchnumber:13031731,13031733,13031832) according to the technology obtained. Thefinal product test resulted that they all accorded with the relevant indicator of ChinesePharmacopoeia.3.We carried out high-temperature test, humidity test, strong light test, acceleratedtest and sample inspection test at room temperature for three batches of pharmaceuticalexcipients maltodextrin (batchnumber:13031731,13031733,13031832), stability testresults showed that:(1) The sample placed in the same packaging material for the finished samples,were placed at high temperature (60℃) for10days, or at constant humidity (92.5%RH) for10days, or under the light intensity of4500lux for10days. The investigatedparameters of the examination were all within the specified range, and the indicators stayed stability;(2) The sample placed in the same packaging material for the finished samples,were placed at high temperature and humidity conditions (38℃, RH75%) for6months, and the indexes of the test were inspected, then, the test results showed theindicators still kept stable. So the tentative shelf life was12months;(3) The sample placed in the same packaging material for the finished samples,were examined as long-term retention samples at room temperature for36months.Stability trial is still ongoing.4. In the compatibility test, the maltodextrin and the amino acid didn’t occur Maillardreaction normally in within the scope of acidic pH5.0~7.0, so maltodextrin and aminoacids drug may be compatible and does not affect the efficacy. But in an alkalineenvironment, maltodextrin caused degradation or failure of the effect of amino aciddrugs. Maillard reaction gradually becomes strong as temperature rised and timeextended. When the maltdextrin are combined with amino acids drug, it should not beexposured at high temperatures for a long time; for fear that the efficacy will bereduced. It needs to avoid contacting with strong oxidants when using maltodextrin forpharmaceutical production.