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Multiparticulate l-menthol formulations and related methods

A menthol and multiparticulate technology, applied in the field of high-purity L-multiparticulate preparations, can solve problems such as long residence time and unpredictable

Active Publication Date: 2016-08-10
SOC DES PROD NESTLE SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unit non-disintegrating sustained-release dosage forms are undesirable due to unpredictable absorption and prolonged gastric residence time

Method used

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  • Multiparticulate l-menthol formulations and related methods
  • Multiparticulate l-menthol formulations and related methods
  • Multiparticulate l-menthol formulations and related methods

Examples

Experimental program
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Effect test

example 1

[0043] Example 1: Preparation of multiparticulate formulations

[0044] Experiment Details

[0045] Equipment used to manufacture the formulations described herein included: dish-on-dish balance, hand sieves (12, 14, 16, 18, weighing pan, 70 mesh screen), Rotap rotary sorting sieve, IKA mixer, KitchenAid Food Processor (Pre-Grind), Fitz Mill with 0.065'' Screen, Jet Mill, Key International High Shear Mixer, Glatt GPCC-3 Fluid Bed Dryer, Fluid Bed with 7'' Bottom Spray (wurster) Glatt GPCC-3 fluidized bed dryer, Karl Fischer moisture analyzer and spheronizer.

[0046] Preparation of Nucleus 1

[0047]As shown in Table 1, Core 1 was prepared as described above using the following settings. Wet granulation settings were: paddle speed 300 rpm, chopper speed 3450 rpm, wet granulation time 80 seconds to 90 seconds, maximum paddle power 5.5 amps to 6.2 amps. The extrusion settings were: paddle speed 25 rpm, feeder speed 30 rpm, screen diameter 1.2 mm. The extrudate was loaded to...

example 2

[0056] Example 2: Assays on prepared multiparticulate formulations

[0057] Prepared multiparticulate dosage forms were assayed to determine whether they met or approached the desired USP711 enteric specification. To meet the USP711 specification for enteric coating, less than 10% of the active ingredient should be released within 2 hours in 0.1N HCl solution (“acid phase”). Subsequently, not less than 85% of the active ingredient should be released within 45 minutes in a buffer solution with a pH value of 6.8 (“buffer phase”).

[0058] The data in Tables 5 and 6 indicate that both acrylic resin and Kollicoat coatings can be successfully used with crystalline L-menthol to form enteric-coated L-menthol multiparticulate formulations that meet or approach USP711 enteric specifications. In Tables 5 and 6, the batch identification indicates the core used, the coating on the core and the formulation number for the specific formulation. A secondary coating of 3% by weight hypromell...

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Abstract

The present invention provides an enteric-coated multiparticulate formulation using L-menthol as an active ingredient. In one embodiment, the multiparticulate formulation includes a plurality of microparticles with reduced release in the gastric environment and enhanced release in the neutral pH environment. The microparticles include a core with L-menthol as an active ingredient. The L-menthol supplied to the core is an L-menthol material having a purity of at least 80%. An enteric coating is applied over the core. The enteric coating is effective to release at least 80% of the L-menthol within about 2 hours in a substantially neutral pH environment. Other aspects of the invention include methods of making and using multiparticulate formulations.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Patent Application No. 61 / 441,716, filed February 11, 2011, entitled "Multiparticulate Formulations and Related Methods," which is hereby incorporated by reference in its entirety, and which also claims Priority to U.S. Provisional Patent Application No. 61 / 486,523, entitled "Multiparticulate Formulations and Related Methods," filed May 16, 1999, the entire contents of which are hereby incorporated by reference. technical field [0003] The present invention relates to multiparticulate formulations for the delivery of high purity L-menthol to the intestine, and in particular, to enteric coated high purity L-multiparticulate formulations and related methods. Background technique [0004] For quite some time, essential oils have been used due to their biological activity. Today, some essential oils are used as medicines. For example, the plant peppermint or wild pepp...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16
CPCA61K9/5026A61K9/5073A61K31/045A61P1/00A61P1/04A61K9/0053A61K9/50A61K9/5042A61K9/5047A61K9/5089A61K47/38
Inventor 赛义德·M·沙阿丹尼尔·哈森萨拉·哈森
Owner SOC DES PROD NESTLE SA
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