片 剂 ( tablets )
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Tablets
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1.
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2.
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() 2005
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1.(Compressed tablets)0.1g0.5gB1 (Coated tablets)(sugar coated tablets)(film coated tablets)(enteric coated tablets) (Multilayer tablets)(Tablets by dry coating) (Model tablets)
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2.
(Buccal tablets, Toroches) (Buccal patch) (Chewable tablets)(Sublingual tablets)(Vaginal tabets)(Implant tabets)(Hypodermic tablets)
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3.
(Immediate release tablets) (Sustained release tablets)(Controlled release tablets)(Dispersible tablets )(Effervescent tablets)#/CO2 (Solution tablets)
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4.
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AdjuvantsAdditivesExcipients() ()
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()(Fillers)(Diluents)(Absorbents)5mm100mg (50mg)
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(Starch)#200-980MW 104-105 20%1.
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-Pregelatinized starch
(Lactose)# -
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(Dextrin)MW 102-10480%
(Sugar)
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MannitolSorbitol
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2.
(Microcrystalline cellulose, MCC)# 101102
(Powdered cellulose)1500MW 2.43105,
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(Calcium sulphate) 70C
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()Moistening agents
(Distilled water)
(Ethanol)()
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()Adhesives)
1.#hydroxypropylmethylcellulose,HPMC 2%5%550cPas hydroxypropylcellulose,HPC(MCC)methylcellulose,MC (carboxymethylcellulose ,CMC-Na ethylcellulose,EC
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2polyvinylpyrrolidine,PVP#K15K30K90 10% PVP K30 3.(Starch slurry) 70C520% (Dextrin) (Sugar and Syrup) 1070g/g
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4.(Mucilage)5101025
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()(Disintegrants)
+>> >>
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1. croscarmellose sodium,CCNa Ac-Di-Sol 0.5%5%
2. crospovidone, PVPP0.5%5% 3. carboxymethyl starch sodium, CMS-Na#2
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4.L-HPC#500%700% 25
5. 5%20%
6. 80SDS
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()(Lubricants)
1.(glidants)(anti-adherents)(lubricants)
()200
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2. 60
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3.(Magnesium stearate)0.3%1% (Talc) 5%(Hydronated plant oil)
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PEG PEG4000600050um
Sodium dodecyl sulphate,SDS
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Colloidal silicon dioxide, aerosil100-350m2/g 0.15%3% Aerosil
Talc
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Color additives, Colorants, Coloring agents
Aromatizing agents,
Sweetening agents
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wet granulation
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2.12345 3.
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()Granulation
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1.# (Extrusion) (1).1) 801001202) 3)
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(2). 12-20
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2#(Wheeling)+2-3mm
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3.#(Fluid bed) 30-80
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4.#(Spray dry) 50%60%()
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5.#(High-velocity shearing)
()()()
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6.#(Compound device)++
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7.Spherical crystallization in liquids
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(Drying)
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(Re-granulation)
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()(Tableting) 1.
1() ()%+=100 mg /50%=200mg7.5%185-215mg
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2.
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# (Single punch tablet press)
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12
123
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123456
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()
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#(Rotary tablet press)()()(////) 161927335575
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Dry granulation and press tablets 12.
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31pressure roll process
2double compressionslugging method19mm5-20g
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(press tablets directly)
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1
C
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212123(MCC)()
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/
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(Capping, Laminating)#/
(Cracking, Chipping)
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Sticking, Binding
(Delay of disintegration)
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5.(Variance of tablet weight beyond the limit)
6.(Color changes or spots)
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7.(Disqualification of content uniformity)
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(Tablet coating)1.
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2.
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3.
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1. 2. 3.
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1.#(Pan coating)+3040 2040/min
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( fluidized bed coating)
compression coating123
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()(Film coating) 25
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()(Solvents)30%E30D ()(Plasticizers) ()
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(Sugar coating) 1 // 30-35%10-15%65%:
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+40C-50C3-5 +40C 55C15-1840C15-1840C(Glassing)2%24
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()(Apperance) 10075W60cm30cm30s
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()(Hardness)#
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()(Friability)#% 2000
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Roche25r/min100(4min)1%()RH%40%
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()(Variance of tablet weight)%
- ()(Content uniformity)
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()(Limit for disintegration time)2mm
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61000ml371C3032
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()(Dissolution)#
?
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()1000ml37C 0.5C50200
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()(Limit for microbes)
1000/g100/g
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()( ) ()+()
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(Examples)
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() [] 400g 800g HPMC3% 180200g 80g 3g 1000
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[]+80HPMC141670C80C14
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()
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[] 268g 136g 33.4g (17%) 15g 266g 0.25g 1000
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[]+1001/31470C12[]1. 100C105C2.
- ()
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[] 5g 50% 60g 0.7g 18g 1.5g 1000[] 50%
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[]+501655C16[] B2
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[] 88.8g 38.0g 17% 10% (0.6g) 1.0g 1000(0.5mg/)
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[]301040C50-60 []
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[] 1 57.5g 10% 10g 3.6g 1000
Eudragit L100 28g 85% 560ml 80 5.6g 16.8g 5.6g 16.8g
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[]1080-90C5g12Eudragit85%80
[]
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