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A method of producing fast dissolving tablets

An instant tablet, instant technology, used in pharmaceutical formulations, medical preparations with non-active ingredients, pill delivery, etc.

Inactive Publication Date: 2010-06-02
ROYAL COLLEGE OF SURGEONS & IRELAND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While tablets produced according to these methods do not break easily and typically do not require specialized packaging, the methods involved in their production are resource and energy intensive and often require the use of additional functional tablet excipients to be able to process these materials

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] The following tableting excipients were weighed and mixed in a sealed plastic bag for 5 minutes: 37.25g Mannitol 200, 5g Explotab, 5g Calcium Silicate and 2.5g Uncoated Diclofenac Sodium. After 5 minutes of mixing, 0.25 g of magnesium stearate was added and mixed gently for 1 minute. The powder mixture was then transferred to the hopper of a Piccola tablet press (8-position rotary tablet press operating at a speed of 14 tablets per minute) equipped with 15 mm flat, beveled-edged round dies and compressed at 15 kN pressure. Tablets with a target tablet weight of 500 mg were produced. The resulting tablets were tested for weight uniformity, hardness and disintegration time. The tablets showed an average weight of 517 mg, a hardness of 54 Newtons and a disintegration time of 1 minute 20 seconds.

Embodiment 2

[0089] Example 1 was repeated using Eudragit E coated Diclofenac sodium prepared by spray drying a solution of Diclofenac sodium and Eudragit E in ethyl acetate (as described in Example 8 below). The formulation used was adjusted to maintain the content of diclofenac at 25mg / 500mg tablet weight. In place of 2.5 g of Diclofenac Sodium, 10 g Eudragit E-coated Diclofenac Sodium was used and mixed with 29.75 g Mannitol 200, 5 g Explotab and 5 g Calcium Silicate. After 5 minutes of mixing, 0.25 g of magnesium stearate was added and mixed gently for 1 minute. Tablets were produced under a pressure of 12 kN, the tablets exhibited a hardness of 72 Newtons and a disintegration time of 40 seconds. The average tablet weight is 420mg.

Embodiment 3

[0091] Control FDDTs were produced using a mixture comprising 44.75 g mannitol 200, 5 g anhydrous citric acid and 0.25 g magnesium stearate. The mixture was prepared as in Example 1 and tablets were produced under a pressure of 10 kN. The tablets produced had an average weight of 520 mg and exhibited a hardness of 56 Newtons and a disintegration time of 16 seconds.

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Abstract

A method of producing a fast-melt tablet comprises the steps of forming a mixture of components, the mixture comprising at least one fast dissolving sugar alcohol, at least one disintegrant or osmotic agent, and at least one an active component, blending the mixture for a period of time, and directly compressing the blended mixture at a compression force of typically between 5 and 2OkN to form the fast-melt tablet. The process of the invention does not involve any granulation step, thereby making the process more energy efficient and cost effective. The fast dissolving sugar alcohol is selected from the group comprising: mannitol; sorbitol; erythritol; xylitol; lactose; dextrose; and sucrose, and comprises at least 50%, preferably at least 60%, and more preferably at least 70%, of the tablet (w / w). The active component is suitably provided in the form of microparticles or microcapsules having an average diameter of less than 125 microns. Also described are directly compressed fast dissolving type tablets obtainable by the process of the invention. The tablets typically are flat-faced.

Description

technical field [0001] The present invention relates to a method for producing an instant tablet, and an instant tablet obtained according to the method of the invention. Background technique [0002] The application of plain tablets is often challenging for the elderly, children, and uncooperative patients who have difficulty swallowing. Also, swallowing plain tablets can be problematic when the patient suffers from a persistent cough or gag reflex, or when water is not available. These problems have been partially solved in recent years by the provision of fast dissolving tablets. These tablet forms are also known as FDDT (fast dissolving disintegrating tablets), fast melting or dissolving tablets. Typically, these tablets include one or more hydrophilic disintegrants that rapidly absorb saliva and dissolve or disperse in less than 1 minute when placed on the tongue or in the mouth. The problem with providing these tablets is the need to provide tablets that are hard en...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/20A61K47/42A61K47/30
CPCA61K9/2013A61K9/2018A61K9/2081A61K9/2054A61K9/2027A61K9/2095A61K9/0056A61K9/2009A61K9/5026A61K9/1635A61P25/00
Inventor 泽巴尼萨·瑞姆度拉里特什·帕巴里约翰·凯利
Owner ROYAL COLLEGE OF SURGEONS & IRELAND