




版权说明:本文档由用户提供并上传,收益归属内容提供方,若内容存在侵权,请进行举报或认领
文档简介
1、 Generic Drug FormulationswithKollicoat SR 30 DandKollidon SRContentsI. Kollicoat SR 30 DCoating1.1 Theophylline sustained-release pellets 1.2 Theophylline sustained-release pellets(drug-layering process2. Caffeine sustained-release pellets(extrusion process3.1 Propranolol HCl sustained-release pell
2、ets(extrusion process3.2 Propranolol HCl sustained-release pellets(drug-layering process3.2.1 Propranolol HCl pellet-releasing tablet4. Acetaminophen taste masked5. Ibuprofen sustained-release pellets(drug-layering process6. Ambroxol HCl sustained-release pellets(drug-layering process6.1 Ambroxol HC
3、l pellet-releasing tablet7. Tramadol HCl sustained-release pellets(drug-layering process8. Acetylsalicylic acid crystalsGranulation9. Propranolol HCl sustained-release tablet10. Theophylline sustained-release tablet11. Carbamazepine sustained-release tabletII. Kollidon SR12. Metoprolol tartrate sust
4、ained-release tablet13. Propranolol HCl sustained-release tablet14. Caffeine sustained-release tablet15. Diclofenac Na sustained-release tablet16. Ascorbic acid sustained-release tablet17. Indometacin sustained-release tablet18. Carbamazepine sustained-release tablet19. Nifedipine sustained-release
5、tablet20. Tramadol HCl sustained-release tablet21. Diltiazem HCl sustained-release tablet22. Naphtidrofuryl oxalate sustained-releasetablet23. Theophylline sustained-release tablet1.1 Theophylline sustained-release pelletsa FormulationWater44.73g b Preparation of the spray suspensionPolymer suspensi
6、on Add propylene glycol followed by Kollicoat SR30 D to the given quantity of water with stirring. Pigment suspension Dissolve Kollidon 30 in the given quantity ofwater. Add Sicovit Red 30, titanium dioxide andtalc with vigorous stirring and homogenize themixture in a corundum disk mill.Spray suspen
7、sion Incorporate the pigment suspension into thepolymer suspension with stirring. The suspensionmust be stirred during the spraying process toprevent settling.c CoatingThe pellets were coated in an Aeromatic Strea-1 (Aeromatic AG. The suspension was sprayed continuously onto the fluidized, pre-heate
8、d pellets from the top. Process parameters Inlet air temperature60COutlet air temperature37CProduct temperature38CAir flow80m/hSpraying time39 minDrying45C/ 5minCoating weight2mg film former/cmThe coating weight of 2mg film former / cm given here was determined from the surface area of the pellets.
9、Since the particle size distribution and surface structure influence the polymer quantity required, calculating the surface area is recommended as a means of estimating the required coating weight in each specific case. 1.2 Theophylline sustained-release pellets(drug-layering processa FormulationThe
10、 formulation is designed for 800g of pellets manufactured by drug layering of nonpareilles.Water100.0g b Preparation of the spray suspensionPolymer suspension Add TEC followed by Kollicoat SR 30 D to thegiven quantity of water with stirring.Pigment suspension Add talc to the given quantity of water
11、withvigorous stirring.Spray suspension Incorporate the pigment suspension into thepolymer suspension with stirring. The suspensionmust be stirred during the spraying process toprevent settling.c CoatingThe pellets were coated in an GPCG1 (Glatt. The suspension was sprayed continuously onto the fluid
12、ized, pre-heated pellets by the Wurster method.Process parameters Machine Glatt GPCG1Method Bottom-spray (WursterInlet air temperature50-55COutlet air temperature29-32CProduct temperature35-40CAir flow90m/hSpraying time260 minSpraying rate approx. 4.5 g/minDrying40C/ 15min20%Coating weight 2. Caffei
13、ne sustained-release pelletsa FormulationThe formulation is designed for 500g of pellets (composition of pellets: 10% caffeine 1, 43.75% Avicel PH 101 5, 43.75% lactose 6, 2.5% Kollidon VA 64 1; diameter 0.7-1.4mm; made by wet extrusion.Water53.89g b Preparation of the spray suspensionPolymer suspen
14、sion Add propylene glycol followed by Kollicoat SR 30 Dto the given quantity of water with stirring.Pigment suspension Dissolve Kollidon 30 in the given quantity of water.Add Sicovit Red 30, titanium dioxide and talc withvigorous stirring and homogenize the mixture in acorundum disk mill.Spray suspe
15、nsion Incorporate the pigment suspension into the polymersuspension with stirring. The suspension must bestirred during the spraying process to prevent settling.The pellets were coated in an Aeromatic Strea-1 (Aeromatic AG. The suspension was sprayed continuously onto the fluidized, pre-heated pelle
16、ts from the top. Process parameters Inlet air temperature60COutlet air temperature36CProduct temperature37CAir flow80m/hSpraying rate approx. 12g/minSpraying time45 minDrying45C/ 5minCoating weight3mg film former/cmThe coating weight of 3mg film former / cm given here was established for the pellets
17、 by surface area determination. Since the particle size distribution and surface structure influence the required polymer quantity, calculating the surface area is recommended as a means of estimating the required coating weight in each specific case. (extrusion processa FormulationThe formulation i
18、s designed for 500g of pellets (composition of pellets: 20% propranolol HCl 1, 51.66% Avicel PH 101 5, 25.84% lactose 6, 2.5% KollidonVA 64 1; diameter 0.4-1.5mm; made by wet extrusion.Water44.91g b Preparation of the spray suspensionPolymer suspension Add propylene glycol followed by Kollicoat SR30
19、 D to the given quantity of water with stirring. Talc suspension Add talc with vigorous stirring and homogenizethe mixture in a corundum disk mill.Spray suspension Incorporate the talc suspension into the polymersuspension with stirring. The suspension must bestirred during the spraying process to p
20、reventsettling.The pellets were coated in an Aeromatic Strea-1 (Aeromatic AG. The suspension was sprayed continuously onto the fluidized, pre-heated pellets from the top. Process parameters Inlet air temperature60COutlet air temperature35CProduct temperature36CAir flow80m/hSpraying rate approx. 13g/
21、minSpraying time39 minDrying45C/ 5minCoating weight3mg film former/cmThe coating weight of 3mg film former / cm given here was established for the pellets by surface area determination. Since the particle size distribution and surface structure influence the required polymer quantity, calculating th
22、e surface area is recommended as a means of estimating the required coating weight in each specific case. (drug-layering processa FormulationThe formulation is designed for 800g of pellets manufactured by drug layering of nonpareilles.Water100.0g b Preparation of the spray suspensionPolymer suspensi
23、on Add TEC followed by Kollicoat SR 30 D to thegiven quantity of water with stirring.Pigment suspension Add talc to the given quantity of water withvigorous stirring.Spray suspension Incorporate the pigment suspension into thepolymer suspension with stirring. The suspensionmust be stirred during the
24、 spraying process toprevent settling.The pellets were coated in a Glatt GPCG1 coater. The suspension was sprayed continuously onto the fluidized, pre-heated pellets from the bottom by the Wurster method. Weight gains of 5, 10, 15 and 20% were tested.Process parameters Machine Glatt GPCG1Method Botto
25、m-spray (WursterInlet air temperature50-55COutlet air temperature29-32CProduct temperature35-40CAir flow90m/hSpraying time220 minSpraying rate approx. 4.5 g/minDrying40C/ 15minCoating weight20% 3.2.1 Propranolol HCl pellet-releasing tableta FormulationThe formulation is designed for 500g of tablets:
26、b ProcedureMix the ingredients together, pass through a 0.8mm sieve and compress into tablets with a force of about 15kN.Tablet press Korsch EK0, 30 tablets/ minCompression force15kNc Tablet propertiesWeight400mgDiameter10mmForm biplanarHardness82-112N 4. Acetaminophen - taste maskeda FormulationThe
27、 formulation is designed for 500g of acetaminophen granules 1.b Preparation of the spray suspensionThe dispersion is used directly without any additives.c CoatingThe crystals were coated in an Aeromatic Strea-1 (Aeromatic AG. The dispersion was sprayed continuously onto the fluidized, pre-heated cry
28、stals from the top. Process parameters Inlet air temperature60COutlet air temperature40CProduct temperature41CAir flow80m/hSpraying rate approx. 9g/minSpraying time9 minDrying45C/ 5minCoating weight4%Crystalline acetaminophen is coated with 4% Kollicoat SR 30 D. pelletssustained-release5. Ibuprofen(
29、drug-layering processThe formulation is designed for 800g of pellets manufactured by drug layering of nonpareilles.a SubcoatingThe polymer spray solution for a weight gain of 5%:Water432.0g b Preparation of the spray solution (subcoatingDissolve Mowiol in hot water and cool with stirring.Process par
30、ameters Machine Glatt GPCG1Method Bottom-spray (WursterInlet air temperature50COutlet air temperature35CProduct temperature40CAir flow80m/hSpraying time56 minDrying40C/ 15minSubcoating weight5% c Polymer coatingThe formulation is designed for 800g of subcoated pellets.d Preparation of the spray susp
31、ension (polymer coating:Polymer suspension Add TEC followed by Kollicoat SR 30 D to thegiven quantity of water with stirring.Pigment suspension Add talc to the given quantity of water withvigorous stirring.Spray suspension Incorporate the pigment suspension into thepolymer suspension with stirring.
32、The suspensionmust be stirred during the spraying process toprevent settling.Process parameters Machine Glatt GPCG1Method Bottom-spray (WursterInlet air temperature50-55COutlet air temperature29-32CProduct temperature35-40CAir flow90m/hSpraying time230 minSpraying rate approx. 4.5 g/minDrying40C/ 15
33、min Spray the suspension continuously onto fluidized pre-heated pellets by the wurster spray method. Weight gains 5, 10, 15 and 20%. 6. Ambroxol HCl sustained-release pellets(drug-layering processThe formulation is designed for 800g of pellets manufactured by drug layering of nonpareilles.a Formulat
34、ionWater100.0g b Preparation of the spray suspensionPolymer suspension Add TEC followed by Kollicoat SR 30 D to thegiven quantity of water with stirring.Pigment suspension Add talc to the given quantity of water withvigorous stirring.Spray suspension Incorporate the pigment suspension into thepolyme
35、r suspension with stirring. The suspensionmust be stirred during the spraying process toprevent settling.c CoatingThe pellets were coated in an GPCG1 (Glatt. The suspension was sprayed continuously onto the fluidized, pre-heated pellets by the Wurster method.Process parameters Machine Glatt GPCG1Met
36、hod Bottom-spray (WursterInlet air temperature50-55COutlet air temperature29-32CProduct temperature35-40CAir flow90m/hSpraying time220 minSpraying rate approx. 4.5 g/minDrying40C/ 15minWeight gain20% 6.1 Ambroxol HCl pellet-releasing tabletd FormulationThe formulation is designed for 500g of tablets
37、:e ProcedureMix the ingredients together, pass through a 0.8mm sieve and compress into tablets with a force of about 15kN.Tablet press Korsch EK0, 30 tablets/ minCompression force15kNf Tablet propertiesWeight400mgDiameter10mmForm biplanarHardness92-116N 7. Tramadol HCl sustained-release pellets(drug
38、-layering processa Polymer coatingThe formulation is designed for 800g of pellets manufactured by drug layering of nonpareilles.Water100.0g b Preparation of the spray suspensionPolymer suspension Add TEC followed by Kollicoat SR 30 D to thegiven quantity of water with stirring.Pigment suspension Add
39、 talc to the given quantity of water withvigorous stirring.Spray suspension Incorporate the pigment suspension into thepolymer suspension with stirring. The suspensionmust be stirred during the spraying process toprevent settling.c CoatingThe pellets were coated in an GPCG1 (Glatt. The suspension wa
40、s sprayed continuously onto the fluidized, pre-heated pellets by the Wurster method.Process parameters Machine Glatt GPCG1Method Bottom-spray (WursterInlet air temperature50-55COutlet air temperature29-32CProduct temperature35-40CAir flow90m/hSpraying time225 minSpraying rate approx. 4.5 g/minDrying
41、40C/ 15minWeight gain20% 8. Acetylsalicylic acid crystalsa FormulationThe formulation is designed for 800g of acetylicsalicylic acid crystals 12.b Preparation of the spray suspensionAdd talk to the given amount of water with vigorous stirring.Then add Kollicoat SR 30 D with slow stirring.c CoatingTh
42、e crystals were coated in a Glatt GPCG1 coater. The suspension was sprayed continously onto the fluidized, pre-heated crystals by the Wurster method. Weight gains of 5, 10, 15 and 20% were tested.Process parameters Machine Glatt GPCG1Method Bottom-spray (WursterInlet air temperature50-55COutlet air
43、temperature29-32CProduct temperature35-40CAir flow90m/hSpraying time166 minSpraying rate approx. 8.9 g/minDrying40C/ 15minCoating weight20% 9. Propranolol HCl sustained-release tableta Formulation of the granulesb Manufacture of the granulesThe active ingredient and excipient were granulated in an A
44、eromatic Strea-1 (Aeromatic AG. The polymer dispersion was sprayed into the fluid bed from the top. Process parameters Inlet air temperature55COutlet air temperature22 27CSpraying rate approx. 10g/minAtomizing pressure 2.0bar c Formulation of the tabletsd TabletingThe granules were passed together w
45、ith magnesium stearate (0.5% and Aerosil200 (0.5% through an 800m sieve, blended for 10 min in a Turbula mixer and compressed into tablets with a force of about 18kN.Tablet press Korsch EK0, 30 tablets/ mine Tablet propertiesDiameter10mmForm biplanarHardness260N 10. Theophyllinetabletsustained-relea
46、sea Formulation of the granulesb Manufacture of the granulesThe active ingredient and excipient was granulated in an Aeromatic Strea-1 (Aeromatic AG. The polymer dispersion was sprayed into the fluid bed from the top.Process parameters Inlet air temperature55COutlet air temperature22 27CSpraying rat
47、e approx. 10g/minAtomizing pressure 2.0bar c Formulation of the tabletsMagnesium stearate 8 4.0mg d TabletingThe granules were passed together with magnesium stearate (0.5% and Aerosil200 (0.5% through an 800m sieve, blended for 10 min in a Turbula mixer and compressed into tablets with a force of a
48、bout 18kN.Tablet press Korsch PH 106, 30 rpme Tablet propertiesHardness276N 11. Carbamazepinetabletsustained-releasea Formulation of the granulesKollicoat SR 30 D 1131.25g b Manufacture of the granulesThe active ingredient and excipients were granulated in an Aeromatic Strea-1 (Aeromatic AG. The pol
49、ymer dispersion was sprayed into the fluid bed from the top.Process parameters Inlet air temperature55COutlet air temperature22 27CSpraying rate approx. 10g/minAtomizing pressure 2.0bar c Formulation of the tabletsMagnesium stearate 8 2.0mg d TabletingThe granules were passed together with magnesium
50、 stearate (0.5% and Aerosil200 (0.5% through an 800m sieve, blended for 10 min in a Turbula mixer and compressed into tablets with a force of about 18kN.Tablet press Korsch EK0, 30 tablets/ mine Tablet propertiesDiameter11mmForm biconvexHardness136N 12. Metoprolol tartrate sustained-release tableta
51、Formulation of the granulesb Manufacture of the granulesThe active ingredient was granulated in an Aeromatic Strea-1 (Aeromatic AG. The polymer dispersion was sprayed into the fluid bed from the top.Process parameters Inlet air temperature50COutlet air temperature24 28CSpraying rate approx. 10g/minc
52、 Formulation of the tabletsd TabletingThe granules were passed together with magnesium stearate (0.5% and KollidonSR (54.5% through an 800m sieve, blended for 10 min in a Turbula mixer and compressed into tablets with a force of about 10kN.Tablet press Korsch EK0, 30 tablets/ minCompression force9,3
53、kNe Tablet propertiesDiameter12mmForm biplanarHardness220N 13. Propranolol HCl sustained-release tableta Formulationb ProcedureMix the ingredients together, pass through a 0.8mm sieve and compress intotablets with a force of about 10kN.Tablet press Korsch PH 100/6 30 rpmCompression force9,9kNc Table
54、t propertiesDiameter10mmForm biplanar172NHardness 14. Caffeine sustained-release tableta Formulationb ProcedureMix the ingredients together, pass through a 0.8mm sieve and compress into tablets with a force of about 10kN.Tablet press Korsch PH100/6, 30 rpmCompression force9.6kN9.8kN10.1kN c Tablet p
55、ropertiesDiameter10mm10mm10mmForm biplanarHardness213N201N193NFriability0.1%0.1%0.1% 15. Diclofenac Na sustained-release tableta Formulationb ProcedureMix the ingredients together, pass through a 0.8mm sieve and compress into tablets with a force of about 8kN.Tablet press Korsch EK0, 30 tablets/ minc Tablet propertiesDiameter8mmForm biplanarHardness195N229NFriability0.1%0.1% 16. Ascorbic acid sustained-release tableta Formulationb ProcedureMix the ingredients together, pass through a
温馨提示
- 1. 本站所有资源如无特殊说明,都需要本地电脑安装OFFICE2007和PDF阅读器。图纸软件为CAD,CAXA,PROE,UG,SolidWorks等.压缩文件请下载最新的WinRAR软件解压。
- 2. 本站的文档不包含任何第三方提供的附件图纸等,如果需要附件,请联系上传者。文件的所有权益归上传用户所有。
- 3. 本站RAR压缩包中若带图纸,网页内容里面会有图纸预览,若没有图纸预览就没有图纸。
- 4. 未经权益所有人同意不得将文件中的内容挪作商业或盈利用途。
- 5. 人人文库网仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对用户上传分享的文档内容本身不做任何修改或编辑,并不能对任何下载内容负责。
- 6. 下载文件中如有侵权或不适当内容,请与我们联系,我们立即纠正。
- 7. 本站不保证下载资源的准确性、安全性和完整性, 同时也不承担用户因使用这些下载资源对自己和他人造成任何形式的伤害或损失。
最新文档
- 2025年四川省税务系统遴选面试真题附详解含答案
- 内科疾病诊疗成本控制分析
- 化妆品卫生知识培训考核试题(含答案)
- 辽师大版(三起)小升初考试英语试卷
- 2025年上海市高级技工学校招聘考试笔试试题(含答案)
- 基因疾病的探究与治疗方法
- 老师爱岗敬业课件
- 服装品牌代理经销合同范本
- 专业市场场地租赁履约保证金合同
- 拆除工程风险规避与免责合同
- 浙江杭州市2024-2025学年高一下学期6月期末考试英语试题及答案
- 喘息性支气管肺炎的护理查房
- 新型电极材料成本控制-洞察及研究
- 2025年初中数学知识点测试题及答案
- 小学生集体活动安全课件
- 2025-2030年中国高尔夫产品行业市场现状供需分析及投资评估规划分析研究报告
- 成都市2022级(2025届)高中毕业班摸底测试(零诊)数学试卷(含答案)
- 冰淇淋行业招商策划
- 酒店住宿水单模板
- 【教学】第五讲-化学战剂的种类与性质
- 阿贝折射仪使用说明书(
评论
0/150
提交评论