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Famciclovir direct compressed tablet and preparation method thereof

A famciclovir, direct compression tablet technology, applied in the field of medicine, can solve the problems such as the improvement of quality controllability and product stability that are not mentioned, and achieve the advantages of improving fluidity and compressibility, simplifying process and improving stability. Effect

Active Publication Date: 2015-03-25
BEIJING HANMI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above inventions did not mention the improvement of quality controllability and product stability

Method used

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  • Famciclovir direct compressed tablet and preparation method thereof
  • Famciclovir direct compressed tablet and preparation method thereof
  • Famciclovir direct compressed tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: the selection of famciclovir bulk drug

[0043] Famciclovir has good water solubility and accounts for a large amount of prescriptions. Therefore, it is necessary to investigate the particle shape and particle size of the raw material drug to ensure that the raw material drug has good fluidity and compressibility, and is suitable for the direct compression process. The famciclovir APIs produced by Zhejiang Chetou Pharmaceutical Co., Ltd. and Changzhou Kangli Pharmaceutical Co., Ltd. were compared.

[0044] Observe under a microscope at 400 times magnification, such as figure 1 As shown, the particle size of famciclovir API produced by Zhejiang Chetou Pharmaceutical Co., Ltd. is relatively large, the shape is close to spherical, and there are no needle-like and flake-like particles. Such as figure 2 As shown, the famciclovir API produced by Changzhou Kangli Pharmaceutical Co., Ltd. has a smaller particle size and more slender rod-shaped particles. As de...

Embodiment 2

[0047] Embodiment 2: the investigation of direct compression technology feasibility

[0048] Famciclovir tablets were prepared by powder direct compression and wet granulation techniques respectively, and the prescriptions are shown in Table 1:

[0049] Table 1 Famciclovir tablet process screening prescription (every 1000 contains, g)

[0050] Raw materials

Prescription 1 / Direct Compression

Recipe 1 / wet granulation

famciclovir

125.0

125.0

lactose

29.0

29.0

Hypromellose

3.0

3.0

Sodium carboxymethyl starch

2.0

2.0

Magnesium stearate

1.0

1.0

[0051] Preparation Process

[0052] (1) Direct tableting process

[0053] Mix famciclovir, lactose, hydroxypropyl cellulose and sodium carboxymethyl starch evenly, finally add magnesium stearate, mix evenly and press into tablets (DPG-30 single-punch tablet press, Beijing Sinopharm Longli Technology Co., Ltd., manual tablet press) .

[0...

Embodiment 3

[0077] According to the following prescription, the direct compression method is used to make tablets, and the prescription is shown in Table 3.

[0078] Table 3 Famciclovir tablet process screening prescription (every 1000 contains, g)

[0079] Raw materials

[0080] Preparation Process:

[0081] 1) Famciclovir and lactose (Flowlac100) pass through a 26-mesh sieve and mix well

[0082] 2) Mix colloidal silicon dioxide and microcrystalline cellulose (102), pass through a 26-mesh sieve, and mix with the mixture obtained in 1)

[0083] 3) Add the prescribed amount of magnesium stearate to the mixture obtained in 2) and mix evenly

[0084] 4) Tablet pressing (DPG-30 single-punch tablet press, Beijing Sinopharm Longli Technology Co., Ltd.).

[0085] The results are shown in Table 4.

[0086] Table 4 Famciclovir Tablets Prescription Screening Results

[0087] investigation

[0088] *Measurement method of angle of repose: fixed funnel method to measure the...

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Abstract

The invention provides a famciclovir direct compressed tablet and a preparation method thereof. The direct compressed tablet comprises 70-80wt% of famciclovir, 10-20wt% of lactose, 5-15wt% of microcrystalline cellulose, 0.5-1wt% of colloidal silica and 0.5-1wt% of magnesium stearate.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a famciclovir direct-compression tablet and a preparation method thereof. Background technique [0002] Famciclovir (famciclovir, FCV) is a new generation of purine nucleoside antiviral drugs, the chemical name is 6-deoxypenciclovir diacetate, which is developed on the basis of the structure of penciclovir (pencidlovir, PCV). The prodrug of Lowe was developed and listed by the British Smithkline Beecham company in 1994. FCV has a broad-spectrum antiviral effect and is active against herpes virus, hepatitis B virus, cytomegalovirus, Epstein-Barr virus, etc. It is mainly used clinically for simple Herpes zoster, herpes zoster, genital herpes, hepatitis B treatment1). [0003] Because famciclovir is a crystalline powder, its compressibility is poor and its proportion in the prescription is relatively high, there will be cracks and sticky punches during direct compression, thus causi...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/52A61K47/38A61K47/26A61K47/04A61P31/12
Inventor 闫学文方翼杨慧君成仁基
Owner BEIJING HANMI PHARMA CO LTD
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