Preparation Of Amoxicillin Fast-Dissolving Che Wable Tablets And Dry Gel Tablets

Amoxicillin is a semi-synthetic penicillin, clavulanic acid is a "suicide" inhibitor of β-lactamases antimicrobial agent. Amoxicillin or plus clavulanic potassium is widely used in veterinary to treat susceptible bacterial infections. The normal dosage forms of amoxicillin or plus clavulanic potassium conclude tablets, suspensions, soluble powders etc, given easily to livestock and poultry but not easy for pets. Wish my research of amoxicillin fast-dissolving chewable tablets and amoxicillin dry gel tablets can improve pets’ compliance of medicine.1. Preformulation study of amoxicillin fast-dissolving chewable tablets and amoxicillin dry gel tabletsEstablish a method to determine the main drug in amoxicillin fast-dissolving chewable tablets and amoxicillin dry gel tablets.HPLC condition is:filler, C18(Eclipse XDB-C18,5mmx250mm,4.6μm), mobile, phase phosphate buffer (pH4.00)-methanol (95:5), X,=230nm, column temperature30.0℃, v=0.90ml/min. Amoxicillin and clavulanic potassium well seperated. Amoxicillin has a good linear relationship at0.0858-0.858mg/ml(R2=0.9997,n=7), clavulanic potassium has a good linear relationship at10-250μg/ml(R2=0.9972,n=7).Evaluate the impact of main drug and adjuvant by DTC. The results indicate that there is no harmfull impact of main drug and adjuvant in amoxicillin fast-dissolving chewable tablets and amoxicillin dry gel tablets.2. Select and optimize prescription and evaluate the quality of amoxicillin fast-dissolving chewable tabletsEstablish a method to determine the disintegration time in vitro. According to the single factor test select the basic prescription and technics of amoxicillin fast-dissolving chewable tablets. Optimize the prescription by L9(34) orthogonal experiment. The final prescription of amoxicillin fast-dissolving chewable tablets are:Amoxicillin and clavulanic potassium (4:1)62.5%, A8%, B5%, mannitol10%, lactosel2%, fine particle silica1.3%, aspartame1.2%. Thechnology conditions:5%PVP-K30as bonding agent, B added inside and A outside, wet granulation, drying temperature is50℃, drying time is20min, compressive stress is3～4kg.Amoxicillin fast-dissolving chewable tablets prepared are white, bright and clean, the content of main drug, hardness, friability, and the disintegration time all meet Chinese pharmacopoeia’s requirements.3. Select and optimize prescription and evaluate the quality of amoxicillin dry gel tabletsEstablish a method to determine the releasing rate of amoxicillin dry gel tablets in vitro. According to the single factor test select the basic prescription and technics of amoxicillin dry gel tablets. Optimize the prescription by L9(34) orthogonal experiment. The final prescription of amoxicillin dry gel tablets are:Amoxicillin50%, M14%, polyacrylic resin Ⅳ18%, NaHCO314%, A7%, fine particle silica1.8%. Thechnology conditions:10%PVP-K30as bonding agent, wet granulation, drying temperature is50℃, drying time is20min, compressive stress is4～5kg.Amoxicillin dry gel tablets’ drug release mechanism are non-fick diffusion, and the tablets are white like, bright and clean, the content of main drug, hardness, friability, and the release character in vitro all meet Chinese pharmacopoeia’s requirements.4. Evaluate the stability of amoxicillin fast-dissolving chewable tablets and amoxicillin dry gel tabletsAfter alum package, put the tablets under the condition of40±2℃、RH75%±5%for6month. Evaluate the quality at the first, second, third, and sixth month. All tablets’ appearance, content of main drug, hardness, friability, and the release character in vitro all meet Chinese pharmacopoeia’s requirements.