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The Use of EMDEX ® in a Lactose-free Reformulation of Cetirizine Tablets

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Released By JRS Pharma

Abstract
 
Spray-dried lactose is widely used as filler and binder in the pharmaceutical industry, but many adults are not able to digest lactose. Therefore, it is indispensable to provide alternatives to lactose-containing drugs in order to make them suitable for lactose intolerant patients. EMDEX® is a promising substitute for spray-dried lactose as it has similar powder and tableting properties. The aim of this study was to test a lactose-free reformulation of cetirizine tablets. EMDEX® was used successfully as a lactose substitute in cetirizine tablets resulting in comparable tablet properties in terms of crushing strength, disintegration time and dissolution profile. Furthermore, the EMDEX® formulation was characterized by an excellent powder flow and low ejection forces during the tableting process.

Introduction
 
Cetirizine dihydrochloride belongs to the group of second-generation antihistamines and is used in the treatment of hay fever, allergies, angiodema and urticaria. As an H1 antagonist, cetirizine relieves the symptoms of allergical reactions by blocking the ac1,2 tion of histamine at the H1 receptors temporarily. Cetirizine is one of the most common H1 antihistamines, but many cetirizine tablets on the market contain lactose which makes them unsuit3 able for lactose intolerant patients.
 
Approximately 33 % of the global population is affected by lactose intolerance, which is the inability to digest the milk sugar lactose. Lactose intolerance is caused by the shortage of the enzyme lactase, which splits lactose into glucose and galactose, leading to gastrointestinal symptoms, such as abdominal pain, bloating, diarrhea, gas and nausea. Whereas almost all infants produce the enzyme lactase in a sufficient quantity, about 75 % of adults have impaired lactase activity. Especially in large parts of Asia and Africa, lactose intolerance is prevalent. For this reason it is very important to provide alternative excipients for the development of 4,5 lactose-free drugs.
 
A potential substitute for spray-dried lactose is EMDEX®, a directly compressible, water-soluble tablet filler and binder. EMDEX® is composed of 95 % glucose monohydrate and 5 % oligosaccharides resulting from the enzymatic hydrolysis of starch. It is monographed as dextrates in the USP. Due to its comparable properties to spray-dried lactose in terms of powder characteristics and functional tablet parameters, EMDEX® is a promising substitute for lactose.

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