Study On The Formulation And Preparation Process Of Milbemycin Oxime Chewable Tablets

Milbemycin oxime is a new type of macrolide antiparasitic drug,which is the oxime derivative of milbemycin A3 and A4.It is mainly used in the prevention of canine filariasis,the control of the disease of dog and cat caused by ascaris lumbricoides and hookworm,and the treatment of dogs’ trichuriasis.However,the products on the market are ordinary tablet currently,which have poor palatability.Firstly,the formulation and preparation process of milbemycin oxime chewable tablets were studied and confirmed.Using the method similar to the in vitro dissolution of original products,through the compatibility test of raw and excipients,the test of excipients dosage and the test of formulation optimization,the result showed in vitro dissolution similarity factors(f2)of the initial formulation was 66.Wet granulation technology was applied in the study,drying temperature and tablet pressing parameters were studied.The results showed that the drying temperature was determined to be 45±5℃,and the best tablet hardness was 9.00～13.00 kg.The dissolution of milbemycin oxime chewable tablets was tested by HPLC method.The dissolution similarity factors of the prepared products and RLD in four different dissolution media(four media pH=1.2,pH=4.5,pH=6.8,water)were calculated.The results of similarity factors(f2)were 78,74,76,85,and the similarity factors(f2)were all greater than 50,so the final formulation and process were confirmed.Secondly,the method of product analysis was validated,and the limits of key quality indicators of the product were established,such as Impurity D≤1.0%,other Maximum Single Impurity<1.0%,Total Impurity ≤4.0%,Content Limit 90%～110%,and the dissolution could not less than 85%of the labeled amount within 30 minutes..Finally,the stability and palatability of milbemycin oxime chewable tablets were evaluated.The results showed that all the key quality indicators of the products met the limits within two years,and the automatic feeding rate reached 96%,which achieved excellent palatability.The results of the final test showed that the formulation and preparation process of milbemycin oxime chewable tablets was simple,the product was safe and stable,the quality was controllable,and the palatability was good.