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Famciclovir slow-releasing capsule for anti-virus treatment and its producing method

A technology of famciclovir and sustained-release capsules, which is applied in the field of famciclovir sustained-release capsules, can solve the problems of large and unfavorable changes in blood drug concentration, and achieve the effects of slow increase in blood drug concentration, reduced number of administrations, and stable concentration changes

Active Publication Date: 2006-01-04
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] After oral administration of famciclovir tablets, the plasma concentration changes greatly, which is very unfavorable for either single antiviral therapy or combined antiviral therapy
There are 130 million hepatitis B virus carriers (including 3 million chronic hepatitis B patients) in China. In view of the lack of good medicines for the treatment of hepatitis B in clinical practice, it is necessary to develop a new dosage form of famciclovir

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0060] A kind of famciclovir slow-release capsule for antiviral treatment, it is characterized in that: the famciclovir drug layer is wrapped with auxiliary material pellets to form a ball core, and a water-insoluble polymer is formed outside the drug layer to control the controlled release inner layer of drug release. The controlled-release inner layer is coated with an enteric-coated polymer to make famciclovir sustained-release pellets, and the pellets are filled in capsules to form famciclovir sustained-release capsules.

[0061] According to the calculation of 1000 sustained-release capsules, the weight of each thousand capsules is 192-220g, and the weight percentage of various components in the capsule to the total filling is composed as follows:

[0062] The percentage by weight of each component in the ball core to the total filling is:

[0063] Famciclovir 56.8%

[0064] Sucrose 13.1%

[0065] Starch 5.1%

[0066] Micronized silica gel 1.1%

[0067] Povidone (or h...

Embodiment approach 2

[0083] Others are the same as embodiment 1, but the weight percent composition of the filling in the capsule is as follows:

[0084] Calculated by making 1000 slow-release capsules, the weight percentages of various components in the capsules to the total filling are as follows:

[0085] The percentage by weight of each component in the ball core to the total filling is:

[0086] Famciclovir 61.00%

[0087] Sucrose (or microcrystalline cellulose) 14.05%

[0088] Starch 5.45%

[0089] Micronized silica gel 1.20%

[0090] Binder: povidone (or hypromellose) 2.70%

[0091] The percentage by weight of each component in the controlled-release inner layer to the total filling is:

[0092] Water-insoluble polymer (quaternary amine methacrylate or ethyl cellulose) 5.75%

[0093] Polyethylene glycol 6000 0.575%

[0094] Antiblocking agent (talcum powder) 1.44%

[0095] Magnesium Stearate 1.44%

[0096] The percentage by weight of each component in the controlled-release outer lay...

Embodiment approach 3

[0105] Others are the same as embodiment 1, but the weight percent composition of the filling in the capsule is as follows:

[0106] Calculated by making 1000 slow-release capsules, the weight percentages of various components in the capsules to the total filling are as follows:

[0107] The percentage by weight of each component in the ball core to the total filling is:

[0108] Famciclovir 65.20%

[0109] Sucrose (or microcrystalline cellulose) 15.00%

[0110] Starch 5.80%

[0111] Micronized silica gel 1.30%

[0112] Binder: Povidone 2.90%

[0113] The percentage by weight of each component in the controlled-release inner layer to the total filling is:

[0114] Water insoluble polymer (quaternary amine methacrylate or ethyl cellulose) 3.6%

[0115] Polyethylene glycol 6000 0.36%

[0116] Antiblocking agent (talc powder) 0.91%

[0117] Magnesium Stearate 0.91%

[0118] The percentage by weight of each component in the controlled-release outer layer to the total fill...

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Abstract

The present invention relates to a kind of slow-releasing famciclovir capsule for antiviral treatment, and features that the slow-releasing famciclovir capsule is prepared through coating famciclovir medicine with supplementary material to form the pellet core, coating the pellet core with inner release controlling layer of water insoluble polymer, re-coating with outer release controlling layer of enteric polymer to form release controlling famciclovir pellet, and encapsulating famciclovir pellet to form the slow-releasing famciclovir capsule. In artificial gastric juice and artificial intestinal juice, the slow-releasing famciclovir capsule has its medicine releasing degree of 10-30 %, 30-70 % and over 70 % separately in 1.5 hr, 3 hr and 8 hr. The pellet is measured to have medicine content of 56.8-65.2 %.

Description

technical field [0001] The invention relates to a famciclovir sustained-release capsule for antiviral treatment and a production method thereof. Background technique [0002] Famciclovir (famciclovir, FCV) is an acyclic nucleoside antiviral drug synthesized by Harnden et al. in 1985, developed by GSK (GlaxoSmithKline) and put on the market in 1994. It is a guanosine nucleoside analogue. It has inhibitory effect on herpes simplex virus type I (HSV-I), type II (HSV-II), herpes zoster virus (VZV) and hepatitis B virus (HBV), and is clinically used to treat herpes zoster, facial herpes and When treating genital herpes, its curative effect is better than that of acyclovir, which is commonly used in clinical practice. Its role in the treatment of hepatitis B has also been paid more and more attention by people. At present, famciclovir, as a new drug for the treatment of chronic hepatitis B, is undergoing clinical research. [0003] Famciclovir is the prodrug of penciclovir (Penc...

Claims

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Application Information

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IPC IPC(8): A61K31/522A61K9/52A61P31/12A61P31/22A61P1/16
Inventor 张明张文浩
Owner LIVZON PHARM GRP INC
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