TY - JOUR
T1 - The influence of formulation and manufacturing process parameters on the characteristics of lyophilized orally disintegrating tablets
AU - Jones, Rhys J.
AU - Rajabi-Siahboomi, Ali
AU - Levina, Marina
AU - Perrie, Yvonne
AU - Mohammed, Afzal R.
N1 - Creative commons : Attribution
PY - 2011/7/20
Y1 - 2011/7/20
N2 - 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.
AB - 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.
KW - freeze-drying
KW - gelatin
KW - ionic strength
KW - milling
KW - orally disintegrating tablets
KW - pH
UR - http://www.scopus.com/inward/record.url?scp=80053029702&partnerID=8YFLogxK
U2 - 10.3390/pharmaceutics3030440
DO - 10.3390/pharmaceutics3030440
M3 - Article
AN - SCOPUS:80053029702
SN - 1999-4923
VL - 3
SP - 440
EP - 457
JO - Pharmaceutics
JF - Pharmaceutics
IS - 3
ER -