Next Article in Journal
Fourth Generation Phosphorus-Containing Dendrimers: Prospective Drug and Gene Delivery Carrier
Previous Article in Journal
Rapid Detection and Identification of Overdose Drugs in Saliva by Surface-Enhanced Raman Scattering Using Fused Gold Colloids
Article

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

1
Aston Pharmacy School, Aston University, Birmingham, B4 7ET, UK
2
Colorcon, Inc., Harleysville, PA 19438, USA
3
Colorcon Limited, Flagship House, Victory Way, Crossways, Dartford, DA2 6QD, UK
*
Author to whom correspondence should be addressed.
Pharmaceutics 2011, 3(3), 440-457; https://doi.org/10.3390/pharmaceutics3030440
Received: 20 June 2011 / Revised: 11 July 2011 / Accepted: 18 July 2011 / Published: 20 July 2011
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. View Full-Text
Keywords: freeze-drying; orally disintegrating tablets; gelatin; pH; ionic strength; milling freeze-drying; orally disintegrating tablets; gelatin; pH; ionic strength; milling
Show Figures

MDPI and ACS Style

Jones, R.J.; Rajabi-Siahboomi, A.; Levina, M.; Perrie, Y.; Mohammed, A.R. The Influence of Formulation and Manufacturing Process Parameters on the Characteristics of Lyophilized Orally Disintegrating Tablets. Pharmaceutics 2011, 3, 440-457. https://doi.org/10.3390/pharmaceutics3030440

AMA Style

Jones RJ, Rajabi-Siahboomi A, Levina M, Perrie Y, Mohammed AR. The Influence of Formulation and Manufacturing Process Parameters on the Characteristics of Lyophilized Orally Disintegrating Tablets. Pharmaceutics. 2011; 3(3):440-457. https://doi.org/10.3390/pharmaceutics3030440

Chicago/Turabian Style

Jones, Rhys J., Ali Rajabi-Siahboomi, Marina Levina, Yvonne Perrie, and Afzal R. Mohammed 2011. "The Influence of Formulation and Manufacturing Process Parameters on the Characteristics of Lyophilized Orally Disintegrating Tablets" Pharmaceutics 3, no. 3: 440-457. https://doi.org/10.3390/pharmaceutics3030440

Find Other Styles

Article Access Map by Country/Region

1
Only visits after 24 November 2015 are recorded.
Back to TopTop