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Continuing release recipe of containing infusible basic remedy

A main drug, release-type technology, applied in pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as difficult mixing and uniformity

Inactive Publication Date: 2008-11-26
PANION & BF BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using only sodium alginate can not only control the release of erythromycin derivatives, but also avoid the problem that the components are difficult to mix evenly during the manufacturing process

Method used

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  • Continuing release recipe of containing infusible basic remedy
  • Continuing release recipe of containing infusible basic remedy
  • Continuing release recipe of containing infusible basic remedy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1. Granulation of controlled release tablets

[0020] All lozenge formulations were prepared by the general method of manufacture as described below. The clarithromycin, sodium alginate, lactose, and stearic acid were all passed through a No. 40 sieve to remove any large lumps, and the sieved material was mixed in a Supermixer for 20 minutes, then slowly A solution of povidone and citric acid was added to form suitable granules. The wet granules passed through a No. 16 sieve, and were dried with hot air at 60°C until the moisture content of the granules was 5-7% as measured by a Karl Fisher moisture analyzer. After passing through a No. 20 screen, the dried granules were mixed with lubricant on a V-blender for 2 minutes.

[0021] 2. Ingot making

[0022] The rotary tablet machine was equipped with an oval mold, and the tablet formulations I, II and III shown in Table 1 below were respectively pressed into suitable thickness and crispness. The composition of the loze...

Embodiment 2

[0028] Solubility studies

[0029] 1. Solubility test, according to page 463 of the 27th edition of the United States Pharmacopoeia (2004)

[0030]0.1M sodium acetate buffer solution: the preparation method is as follows: take 13.61g of sodium acetate trihydrate, put it in a 1-liter volumetric flask, add water to dissolve it and dilute to volume, mix well, and adjust its pH value to 5.0 with 0.1M acetic acid. Solvent: 900 mL of the above 0.1 M sodium acetate buffer solution.

[0031] Device 2: 50rpm

[0032] Sampling time points: 1st, 2nd, 4th, 6th, 8th, 10th, 12th, 18th and 24th hours.

[0033] Mobile phase: Its preparation method is: take a mixture of methanol and 0.067M potassium dihydrogen phosphate solution (the ratio of methanol to 0.067M potassium dihydrogen phosphate solution is 650:350), add phosphoric acid to adjust its pH to 4.0, and use a pore size of 0.5 μm or a finer filter and degassed, and adjusted if necessary.

[0034] Standard solution: The preparation m...

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PUM

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Abstract

A durably releasing prescription contains a primary medicine difficult to dissolve, a water-soluble alginate, and an organic carboxylic acid. A release-controlled lozenge of clamycin is also disclosed.

Description

technical field [0001] The present invention relates to an oral sustained-release formulation of a poorly soluble main drug, such as an erythromycin derivative, which can be digested in gastrointestinal fluid. In particular, the present invention relates to a pharmaceutical composition of clarithromycin which can be administered in the form of one tablet per day. Background technique [0002] Erythromycin and its derivatives are antibacterial agents, they have a wide range of antibacterial activity, and some of the same antibacterial activity as penicillin, especially for Gram-positive cocci, such as enterococcus, hemolytic streptococcus group A , pneumococcus and staphylococcus are effective. The usual dosage is to take 2-4 times a day for 10-14 consecutive days. For ambulatory patients, taking 2 to 4 times a day may cause inconvenience, or forget to take; therefore, it is better to reduce the number of daily doses. Especially for non-hospitalized patients, the solid-sta...

Claims

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Application Information

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IPC IPC(8): A61K47/36A61K31/7048A61K31/7052A61P31/04
Inventor 萧义明刘得宇林明容萧伶蜂江宗明
Owner PANION & BF BIOTECH INC
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