片剂的制备工业药剂授课课件.ppt
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1、片剂的制备工业药剂,(优选)片剂的制备工业药剂,PurposeIntroductionEquipments and MaterialsProceduresExperimental InstructionsQuestionsTest report,Introduction-manufacturing processesQuality control of tabletsThese tests are as listed on the right:Some of the pharmaceutical tablet types based on the way of administration o
2、r presentation to the patient are listed on the right:Compressing the granules into tablets.Buccal and sublingual tabletsThe dosage of adhesives should be aptitude to make the soft material be conglomeration in hand and when fingers press it slightly,it should disperse but does not turn into powders
3、.Materials:Average weightEquipments and MaterialsDry sieving/milling of granules to a certain particle size distribution.Equipments:Materials:Coating agentsTablet design is based on the experience and knowledge of excipients,which are materials serving the purpose of making a good tablet when combin
4、ed with a drug.,Purpose,1.To master the basic technological course of tablets through the preparation of aspirin tablets.2.To be familiar with the quality control of tablets.3.To be familiar with the basic structure and operation method of single-punch.,Introduction,Tablets are solid preparations of
5、 various shapes,usually round,and obtained by compressing uniform volumes of particles containing one or more active ingredients with suitable excipients.,Introduction-tablet types,Some of the pharmaceutical tablet types based on the way of administration or presentation to the patient are listed on
6、 the right:,1.Simple uncoated tablets2.Coated tablets3.Effervescent tablets4.Buccal and sublingual tablets5.Chewable tablets6.Multilayered tablets7.Sugarcoated tablets8.Fast-disintegrating tablets9.Vaginal tablets10.Osmotic tablets11.Controlled-release tablets12.Multicomponent tablets,Introduction-t
7、ablet design,Tablet formulation design starts with a predetermined value,which is the dose size.Tablet design is based on the experience and knowledge of excipients,which are materials serving the purpose of making a good tablet when combined with a drug.,Introduction-tablet design,Tablet excipients
8、 can be classified on the basis of their functionality as listed below:,1.Fillers/diluents2.Binders3.Disintegrants4.Lubricants5.Glidants,6.Buffering agents7.Sweeteners8.Wetting agents9.Coating agents10.Matrix formers,Introduction-manufacturing processes,Deciding on a manufacturing method is a comple
9、x task that requires time,equipment,and formulation optimization,as well as a close collaboration between formulation scientists and process engineers.In general terms,there are three manufacturing processes for tablets:wet granulation,dry granulation,and direct compression.,Introduction-manufacturi
10、ng processes,The purpose of wet granulation is to convert the drug and excipient mixture into granules that flow well into dies,and which are compressible into mechanically strong and acceptable tablets.1.flowability pressibilityWet granulation compression method has been widely used in tablets prod
11、uction,especially for drugs resistant to wet and heat.,Introduction-manufacturing processes,The steps of wet granulation,Premixing drug with other ingredients using a mixer.Transferring the mixture into a traditional low shear granulator where a binder solution is added under a mechanical shear unti
12、l a certain damp mass and a certain granule size are obtained.Wet sieving of granules through a desired screen size.Drying of granules in a tray-oven dryer.Dry sieving/milling of granules to a certain particle size distribution.Adding a lubricant to the dry granules.Compressing the granules into tab
13、lets.,Introduction-manufacturing processes,The steps of wet granulation,混合,压片,填充剂,黏合剂,崩解剂,API,辅料,粉碎和过筛,制软材,干燥,整粒,混合,制湿粒,润滑剂,崩解剂,湿法制粒压片工艺流程,Introduction-manufacturing processes,Equipments and Materials,Equipments:electronic balance,single-punch press,nylon sieve(16 and 18 mesh),punch(9.5mm shallow co
14、ncave punch),etc.Materials:aspirin(in granule crystal),tartaric acid,talcum powder,starch,concentrated hydrochloric acid,sodium hydroxide,distilled water,etc.,Procedure,1.Preparation of aspirin tablets(1)Formulation(weight in 100 tablets)Aspirin30 gStarch 2 gTartaric acid 0.2 g10%starch paste qsStar
15、ch 1 gTalcum powder 1.5 g,(2)Preparing processesPreparing 10%starch paste:Heating the aqueous dispersion of starch(2 g starch and 0.2g tartaric acid in 20mL water)at 80 for 15 min.Grinding aspirin to pass the sieve of 80 meshes.Mixing aspirin powder with starch.Adding 10%starch paste to prepare a da
16、mp mass.Screening the damp mass through a nylon sieve of 18 meshes into granules.Drying of the wet granules at 60 for 15 min.Dry sieving of granules through 16 meshes.Adding starch and talcum powder to dry granules with blending uniformly.Compressing the granules into tablets.,制软材,制湿粒,研磨,混合,干燥,整粒,压片
17、,混合,制淀粉浆,single-punch press,rotary tablet press,2.Single-punch press,manual driving wheel,hopper,feed shoe,cam gearing,core components die(模圈)lower punch(下冲)upper punch(上冲),Drying of the wet granules at 60 for 15 min.Experimental InstructionsWet sieving of granules through a desired screen size.Addi
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