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Challenges In Oral Drug Delivery Are Pill-Swallowing Difficulty And Delivery Of Unpalatable Drugs

Fast dissolving tablets (FDT) are solid unit dosage forms which disintegrate or dissolve rapidly in the mouth without chewing and water. FDTs are also called as fast melt, fast disintegrating or orally disintegrating tablets. In April 2007, the FDA issued draft guidance, Guidance for Industry: Orally Disintegrating Tablets. It considers ODTs to be solid oral preparations that disintegrate rapidly in the oral cavity with an in vivo disintegration time of approximately 30 seconds or less, when based upon the USP disintegration test method or alternative.1 Advantages of FDTs over conventional dosage forms
FDTs have significant advantages of both solid and liquid dosage forms. FDTs remain solid till administration and possess dose accuracy and stability during storage which transform into liquid form within few seconds after its administration for easy swallowing. Methodology Employed For Fdts Formulations Melt granulation Melt granulation technique is a process by which pharmaceutical powders are efficiently agglomerated by a meltable binder. The advantage of this technique compared to a conventional granulation is that no water or organic solvents is needed. Because there is no drying step, the process is less time consuming and uses less energy than wet granulation. It is a useful technique to enhance the dissolution rate of poorly water-soluble drugs, such as griseofulvin.5 This approach to prepare FDT with sufficient mechanical integrity, involves the use of a hydrophilic waxy binder (Superpolystate©, PEG-6-stearate). Superpolystate© is a waxy material with a melting point of 33–37°C and a HLB value of 9. So it will not only act as a binder and increase the physical resistance of tablets but will also help the disintegration of the tablets as it melts in the mouth and solublises rapidly leaving no residues.6 Phase transition process It is concluded that a combination of low and high melting point sugar alcohols, as well as a phase transition in the manufacturing process, are important for making FDTs without any special apparatus. FDT were produced by compressing powder containing erythritol (melting point: 122 °C) and xylitol (melting point: 93 95 °C), and then heating at about 93 °C for 15 min. After heating, the median pore size of the tablets was increased and tablet hardness was also increased. The increase of tablet hardness with heating and storage did not depend on the crystal state of the lower melting point sugar alcohol.7 Sublimation In this method a subliming material like camphor, is removed by sublimation from compressed tablets and high porosity is achieved due to the formation of many pores where camphor particles previously existed in the compressed tablets prior to sublimation of the camphor. A high porosity was achieved due to the formation of many pores where camphor particles previously existed in the compressed mannitol tablets prior to sublimation of the camphor. These compressed tablets which have high porosity (approximately 30%) rapidly dissolved within 15 seconds in saliva.8 Granules containing nimusulide, camphor, crospovidone, and lactose were prepared by wet granulation technique. Camphor was sublimed from the dried granules by vacuum exposure.9 Conventional methods like dry granulation, wet granulation and direct compression with highly soluble excipients, super disintegrants and/or effervescent systems can also be used. Three-dimensional Printing (3DP)
Three-dimensional printing (3DP) is a rapid prototyping (RP) technology. Prototyping involves constructing specific layers that uses powder processing and liquid binding materials. A novel fast dissolving drug delivery device (DDD) with loose powders in it was fabricated using the three dimensional printing (3DP) process. Based on computer-aided design models, the DDD containing the drug acetaminophen were prepared automatically by 3DP system.10 It was found that rapidly disintegrating oral tablets with proper hardness can be prepared using TAG. The rapid disintegration of the TAG tablets seemed due to the rapid water penetration into the tablet resulting from the large pore size and large overall pore volume.11 Mass Extrusion
This technology involves softening of the active blend using the solvent mixture of water-soluble polyethylene glycol and methanol and subsequent expulsion of softened mass through the extruder or syringe to get a cylinder of the product into even segments using heated blade to form tablets. Spray Drying
Maximum drug release and minimum disintegration time were observed with Kollidon CL excipient base as compared to tablets prepared by direct compression, showing the superiority of the spray dried excipient base technique over direct compression technique.12 Cotton Candy Process
This process is so named as it utilizes a unique spinning mechanism to produce floss-like crystalline structure, which mimic cotton candy. Cotton candy process involves formation of matrix of polysaccharides or saccharides by simultaneous action of flash melting and spinning. The matrix formed is partially recrystallized to have improved flow properties and compressibility. This candy floss matrix is then milled and blended with active ingredients and excipients and subsequently compressed to ODT. This process can accommodate larger drug doses and offers improved mechanical strength. However, high-process temperature limits the use of this process. Molding
The molding technology results in tablets with an appropriate dissolution time, even though they are characterized by poor mechanical properties (hardness). Lyophilization or Freeze-Drying
Freeze-drying allows immediate dissolution of the tablets because of their high porosity, and enhances drug stability, especially for moisture-sensitive substances; on the other hand, a porous network is associated with low physical resistance and high friability. Special packaging is required in some cases.
About the Author

Nitesh sharma
M.pharm(QA)
09673012821
nrspharma@gmail.com
date of birth:30/08/1986
address:shashtri nagar,malkapur-443101,maharashtra India.