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Falacyclovir dispersion piece and its preparation method

A technology of famciclovir and dispersible tablets, which is applied in the field of preparation of famciclovir dispersible tablets, can solve the problems of only swallowing, large single dose, inconvenience, etc., and achieve the effects of convenient taking, low production cost and high bioavailability

Inactive Publication Date: 2008-04-09
刘全胜
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Due to the large single dose of this product (125-500mg), ordinary tablets have a large volume and can only be swallowed, which brings inconvenience to the elderly, children, stroke patients and patients who have difficulty swallowing

Method used

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  • Falacyclovir dispersion piece and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Famciclovir 250g

[0027] Microcrystalline Cellulose 200g

[0028] Sodium carboxymethyl starch 40g

[0029] Low-substituted hydroxypropyl cellulose 35g

[0030] Croscarmellose sodium 65g (additional 30g)

[0031] Sodium saccharin 4g

[0032] Talc powder 3g

[0033] Magnesium Stearate 3g

[0034] Get the prescription amount of famciclovir, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, croscarmellose sodium, saccharin sodium, sieve, mix evenly, and add 60% polyvinylpyrrolidone (K30) with an appropriate amount of 0.05g / ml concentration % ethanol solution to make soft material, pass through 18 mesh sieve to granulate, dry at 60°C for 4 hours, granulate with 18 mesh sieve, add talcum powder, magnesium stearate, and the remaining croscarmellose sodium, mix evenly, and press into tablets. have to.

Embodiment 2

[0036] Famciclovir 250g

[0037] Pregelatinized starch 176.8g

[0038] Sodium carboxymethyl starch 30g

[0039] Low-substituted hydroxypropyl cellulose 35g

[0040] Cross-linked polyvinylpyrrolidone 45g (plus 20g)

[0041] Aspartame 2.2g

[0042] Talc powder 5.5g

[0043] Magnesium Stearate 5.5g

[0044] Take the prescribed amount of famciclovir, pregelatinized starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, and aspartame, sieve, mix well, and use an appropriate amount of polyethylene glycol with a concentration of 0.05g / ml The soft material made of pyrrolidone (K30) 60% alcohol solution, granulated through 18 mesh sieve, dried at 60°C for 4 hours, granulated with 18 mesh sieve, added talcum powder, magnesium stearate, and the remaining cross-linked polyvinylpyrrolidone and mixed evenly , ready to be pressed into tablets.

Embodiment 3

[0046] Famciclovir 250g

[0047] Lactose 147g

[0048] Sodium carboxymethyl starch 15g

[0049] Low-substituted hydroxypropyl cellulose 35g

[0050] Cross-linked polyvinylpyrrolidone 40g (plus 25g)

[0051] Aspartame 1.5g

[0052] Micronized silica gel 10g

[0053] Magnesium Stearate 1.5g

[0054] Take the famciclovir, lactose, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, and aspartame of the prescribed amount, sieve, mix well, and use an appropriate amount of 0.05g / ml concentration of polyvinylpyrrolidone (K30) 60% alcohol solution Make soft material, pass through 18-mesh sieve to granulate, dry at 60°C for 4 hours, granulate with 18-mesh sieve, add talc powder, magnesium stearate, and additional cross-linked polyvinylpyrrolidone, mix evenly, and press into tablets.

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Abstract

The invention discloses a famciclovir dispersible tablet which is characterized in that the famciclovir dispersible tablet consists of components of the following weight percentages: 40 to 55 percent of famciclovir, 15 to 35 percent of pregelatinized starch, one or more than one of microcrystalline cellulose and lactose, 15 to 30 percent of sodium carboxymethyl starch, one or more than one of low-substituted hydroxypropyl cellulose, crosslinked polyvinyl pyrrolidone, and crosslinked sodium carboxymethyl cellulose, 0.3 to 1 percent of saccharin sodium or aspartame, 0.25 to 1 percent of magnesium stearate, 0.25 to 1 percent of talcum powder or micro-powder silica gel, and appropriate amount of polyvinyl pyrrolidone. The dispersible tablet of the invention has unique performances of short disintegration time, good dispersed state, rapid drug dissolution, high bioavailability and convenience for administration, the production process does not need special equipment, and the production cost is lower.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy and relates to a pharmaceutical method, in particular to a preparation method of famciclovir dispersible tablets. Background technique [0002] Famciclovir (famciclovir FCV), the chemical name is 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanedioate. The chemical structural formula of famciclovir is as follows: [0003] [0004] Famciclovir (Famciclovir; FCV) is a second-generation open-ring nucleoside anti-herpes virus drug, which is a guanosine nucleoside analogue. It was synthesized and developed by Hamden in 1985 and successfully developed by SmithKline-Beecham in the UK. It was first listed in the UK in 1993 and was approved by the US FDA in 1994 for the treatment of acute herpes zoster virus. It was approved for use in the US after 1997. Its additional indication - the treatment of recurrent herpes simplex virus infection (genital herpes and cold sores) in HIV patients, this is the first...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/52A61K9/20A61K47/32A61K47/38A61P31/22A61P31/20A61P1/16
Inventor 刘全胜
Owner 刘全胜
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