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The Influence of Formulation and Manufacturing Process Parameters on the Characteristics of Lyophilized Orally Disintegrating Tablets

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dc.creator Rhys J. Jones
dc.creator Ali Rajabi-Siahboomi
dc.creator Marina Levina
dc.creator Yvonne Perrie
dc.creator Afzal R. Mohammed
dc.date 2011
dc.date.accessioned 2013-05-30T12:28:01Z
dc.date.available 2013-05-30T12:28:01Z
dc.date.issued 2013-05-30
dc.identifier http://www.mdpi.com/1999-4923/3/3/440/
dc.identifier http://www.doaj.org/doaj?func=openurl&genre=article&issn=19994923&date=2011&volume=3&issue=3&spage=440
dc.identifier.uri http://koha.mediu.edu.my:8181/jspui/handle/123456789/5220
dc.description Gelatin is a principal excipient used as a binder in the formulation of lyophilized orally disintegrating tablets. The current study focuses on exploiting the physicochemical properties of gelatin by varying formulation parameters to determine their influence on orally disintegrating tablet (ODT) characteristics. Process parameters, namely pH and ionic strength of the formulations, and ball milling were investigated to observe their effects on excipient characteristics and tablet formation. The properties and characteristics of the formulations and tablets which were investigated included: glass transition temperature, wettability, porosity, mechanical properties, disintegration time, morphology of the internal structure of the freeze-dried tablets, and drug dissolution. The results from the pH study revealed that adjusting the pH of the formulation away from the isoelectric point of gelatin, resulted in an improvement in tablet disintegration time possibly due to increase in gelatin swelling resulting in greater tablet porosity. The results from the ionic strength study revealed that the inclusion of sodium chloride influenced tablet porosity, tablet morphology and the glass transition temperature of the formulations. Data from the milling study showed that milling the excipients influenced formulation characteristics, namely wettability and powder porosity. The study concludes that alterations of simple parameters such as pH and salt concentration have a significant influence on formulation of ODT.
dc.language eng
dc.publisher Molecular Diversity Preservation International
dc.source Pharmaceutics
dc.subject freeze-drying
dc.subject orally disintegrating tablets
dc.subject gelatin
dc.subject pH
dc.subject ionic strength
dc.subject milling
dc.title The Influence of Formulation and Manufacturing Process Parameters on the Characteristics of Lyophilized Orally Disintegrating Tablets


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