Insights Into Formulation Technologies and Novel Strategies for the Design of Orally Disintegrating Dosage Forms: A Comprehensive Industrial Review

Abstract

Among the various routes of administration, the oral route remains the most convenient and commonly employed route for drug delivery. The oral conventional drug delivery systems have some drawbacks, such as possibility of gastrointestinal destruction of labile molecules, low absorption of macromolecules, slow onset of action, and unavoidable fluctuation in the concentration of drugs which can either lead to under-or over medication with concomitant adverse effects, especially for drugs with small therapeutic index. Therefore, it became essential to design novel oral drug delivery systems to achieve quick dissolution, absorption, rapid onset of action and reduction of drug dose. Among those novel drug delivery systems are oral disintegrating tablets (ODTs). The purpose of this review article is to report the recent advances in ODT systems with emphasis on their preparations, characterizations and applications. Also, it highlights future prospects and possible challenges in the development of an ideal ODT system.

Pharmacotechnical Development and Optimization of Multilayered Tablets: An Updated Industrial Review With Emphasis on Bilayer Tablets

“…Tablet thickness and diameter are determined by using a micrometer caliper (vernier scale) in millimetre unit [79,80].…”

“…The disintegration medium is often 900 ml of purified water kept at a temperature of 37±0.5 °C. The time required for complete disintegration is measured in min [79,80].…”

“…Comparative dissolution studies are mainly carried out against the reference product. In vitro drug dissolution profiles are subsequently compared with the reference product using the similarity (f2) and difference (f1) factors, as described by the following (equation 8) and (equation 9), respectively [79,80]:…”

“…On the other hand, f1 defines the percent difference between two curves at each time point and represents a measurement of relative error between curves. f1 (difference factor) values should be lower than 15 [79,80].…”

Modulatory Effect of Polymer Type and Concentration on Drug Release From Sustained Release Matrix Tablets of Ranolazine: A Comparative Release Kinetic Study

“…Different pharmaceutical technologies and formulation strategies were preliminarily screened for the preparation of RZ sustained-release tablets, such as direct compression using conventional and highfunctionality excipients, dry-granulation, and wet-granulation using pH-independent polymers only, but only wet-and melt-granulation techniques using a blend of multifunctional polymers with controlled microenvironmental pH, showed the best results in terms of in-vitro drug release and comparative dissolution (data not shown). The basic principle of the wet-granulation technique relies on holding powder particles together using an aqueous, alcoholic, hydroalcoholic, or buffered binder solution, while the melt-granulation technique is based on incorporating a melt binder in the tablet preparation [29,30]. F1-F5 formulas were prepared by wet granulation technique, using Eudragit ® L100-55, Methocel ™ E5, and Avicel ® PH-101 intra-granularly, and carnauba wax powder extra-granularly, while F6-F10 formulas prepared by a melt-granulation technique using carnauba wax powder intra-granularly, and Eudragit ® L100-55, Methocel ™ E5, and Avicel ® PH-101 extra-granularly.…”