scholarly journals An Overview of Fast Dissolving Oral Film

2019 ◽  
Vol 9 (4-s) ◽  
pp. 822-825
Author(s):  
Abhishek Meher ◽  
Nachiket S. Dighe

Taste-masking techniques are applied to mask or overcome the bitter or unpleasant taste of active pharmaceutical ingredients/drugs to achieve patient acceptability and compliance. Oral administration of bitter or unpleasant tasting drugs is often the biggest barrier for patient groups, such as pediatrics and geriatrics [1, 2]. Unless the active ingredient is tasteless or does not have any unpleasant taste, taste-masking plays a key role in the success of a final solid oral dosage form. The efficiency of taste-masking is often a key determinant for the success of specialized dosage forms like orally disintegrating tablets and films, and chewable tablets [2]. The mechanisms of taste-masking techniques often rely on two major approaches: the first is to add sweeteners, flavors, and effervescent agents to mask the unpleasant taste, and the second is to avoid the contact of bitter/unpleasant drugs with taste buds. In the past few years, significant progress has been made in the area of taste-masking by applying novel strategies and techniques, such as hot-melt extrusion and microencapsulation.[1,3] The following presents an overview and current status of the industrial approaches and platforms used for taste-masking in oral dosage forms. [1, 2, 4]  Many pharmaceutical companies are switching their products from tablets to fast dissolving oral thin films (OTFs).[6,7] Films have all the advantages of tablets (precise dosage, easy administration) and those of liquid dosage forms (easy swallowing, rapid bioavailability). Statistics have shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosages forms. Pediatric, geriatric, bedridden, emetic patients and those with Central Nervous System disorders, have difficulty in swallowing or chewing solid dosage forms.[7,8] Many of these patients are non-compliant in administering solid dosage forms due to fear of choking.[9] OTFs when placed on the tip or the floor of the tongue are instantly wet by saliva. This technology provides a good platform for patent non- infringing product development and for increasing the patent life-cycle of the existing products. [10, 11]  

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 345 ◽  
Author(s):  
Jose R. Cerda ◽  
Talaya Arifi ◽  
Sejad Ayyoubi ◽  
Peter Knief ◽  
Maria Paloma Ballesteros ◽  
...  

Although not readily accessible yet to many community and hospital pharmacists, fuse deposition modelling (FDM) is a 3D printing technique that can be used to create a 3D pharmaceutical dosage form by employing drug loaded filaments extruded via a nozzle, melted and deposited layer by layer. FDM requires printable filaments, which are commonly manufactured by hot melt extrusion, and identifying a suitable extrudable drug-excipient mixture can sometimes be challenging. We propose here the use of passive diffusion as an accessible loading method for filaments that can be printed using FDM technology to allow for the fabrication of oral personalised medicines in clinical settings. Utilising Hansen Solubility Parameters (HSP) and the concept of HSP distances (Ra) between drug, solvent, and filament, we have developed a facile pre-screening tool for the selection of the optimal combination that can provide a high drug loading (a high solvent-drug Ra, >10, and an intermediate solvent–filament Ra value, ~10). We have identified that other parameters such as surface roughness and stiffness also play a key role in enhancing passive diffusion of the drug into the filaments. A predictive model for drug loading was developed based on Support Vector Machine (SVM) regression and indicated a strong correlation between both Ra and filament stiffness and the diffusion capacity of a model BCS Class II drug, nifedipine (NFD), into the filaments. A drug loading, close to 3% w/w, was achieved. 3D printed tablets prepared using a PVA-derived filament (Hydrosupport, 3D Fuel) showed promising characteristics in terms of dissolution (with a sustained release over 24 h) and predicted chemical stability (>3 years at 25 °C/60% relative humidity), similar to commercially available NFD oral dosage forms. We believe FDM coupled with passive diffusion could be implemented easily in clinical settings for the manufacture of tailored personalised medicines, which can be stored over long periods of time (similar to industrially manufactured solid dosage forms).


Author(s):  
Sakhare Sfurti Shamling ◽  
Siddhi Chavan ◽  
Gurav Poonam Chandrakant ◽  
Rutuja Tanaji Kharat ◽  
Ajit Shankarao Kulkarni

Oral disintegrating tablets are solid dosage form containing medical substances which disintegrate rapidly, usually within few seconds when placed upon tongue requiring no additional water to facilitate swallowing. Solid dosage forms that can be disintegrated, dissolved, or suspended by saliva in the mouth resulting in easy swallowing can provide significant benefits to the pediatric and geriatric population, as well as other patients who prefer the convenience of easily swallowable dosage forms Superdisintegrants are currently approached and utilized in the formulation of the orally disintegrating tablets. The present work includes isolation of starch from Echinochloa Colona and further characterizing it for various physicochemical and phytochemical analysis. The isolated starch has been modified chemically and its disintegrating efficiency has been tested in tablet formulation; the present work also explores the optimization of concentration of starch in formulation of Ibuprofen tablets in comparison with synthetic and natural superdisintegrants. Phytochemical analysis confirmed the presence of starches and carbohydrates. Results indicated that the Echinochloa Colona starch samples could be potential superdisintegrants in orally disintegrating tablets of Ibuprofen. Tablet performance was found to influence by the way of addition of starch, its concentration and the method of tablet preparation. From these results it is possible to conclude that Echinochloa Colona starch could be used as a superdisintegrant.


Author(s):  
Gavin P Andrews

Currently, the pharmaceutical and healthcare industries are moving through a period of unparalleled change. Major multinational pharmaceutical companies are restructuring, consolidating, merging and more importantly critically assessing their competitiveness to ensure constant growth in an ever-more demanding market where the cost of developing novel products is continuously increasing. The pharmaceutical manufacturing processes currently in existence for the production of solid oral dosage forms are associated with significant disadvantages and in many instances provide many processing problems. Therefore, it is well accepted that there is an increasing need for alternative processes to dramatically improve powder processing, and more importantly to ensure that acceptable, reproducible solid dosage forms can be manufactured. Consequently, pharmaceutical companies are beginning to invest in innovative processes capable of producing solid dosage forms that better meet the needs of the patient while providing efficient manufacturing operations. This article discusses two emerging solid dosage form manufacturing technologies, namely hot-melt extrusion and fluidized hot-melt granulation.


Pharmaceutics ◽  
2020 ◽  
Vol 12 (1) ◽  
pp. 81 ◽  
Author(s):  
Noemí Gómez-Lado ◽  
Iria Seoane-Viaño ◽  
Silvia Matiz ◽  
Christine M. Madla ◽  
Vipul Yadav ◽  
...  

Following oral administration, gastric emptying is often a rate-limiting step in the absorption of drugs and is dependent on both physiological and pharmaceutical factors. To guide translation into humans, small animal imaging during pre-clinical studies has been increasingly used to localise the gastrointestinal transit of solid dosage forms. In contrast to humans, however, anaesthesia is usually required for effective imaging in animals which may have unintended effects on intestinal physiology. This study evaluated the effect of anaesthesia and capsule size on the gastric emptying rate of coated capsules in rats. Computed tomography (CT) imaging was used to track and locate the capsules through the gastrointestinal tract. Two commercial gelatine mini-capsules (size 9 and 9h) were filled with barium sulphate (contrast agent) and coated using Eudragit L. Under the effect of anaesthesia, none of the capsules emptied from the stomach. In non-anaesthetised rats, most of the size 9 capsules did not empty from the stomach, whereas the majority of the smaller size 9h capsules successfully emptied from the stomach and moved into the intestine. This study demonstrates that even with capsules designed to empty from the stomach in rats, the gastric emptying of such solid oral dosage forms is not guaranteed. In addition, the use of anaesthesia was found to abolish gastric emptying of both capsule sizes. The work herein further highlights the utility of CT imaging for the effective visualisation and location of solid dosage forms in the intestinal tract of rats without the use of anaesthesia.


2021 ◽  
Vol 11 (1) ◽  
pp. 110-113
Author(s):  
V.T. Iswariya ◽  
Nambaaru Sailaja ◽  
CH. Vamsi Krishna ◽  
G.S. Annammadevi

Super-disintegrating agents are one of the ingredients used in pharmaceutical solid dosage forms. These substances play a vital role in formulation design.  Natural super-disintegrants have gained more popularity due to their oral bioavailability. It disintegrates the tablets into smaller particles to enhance the dissolution rate. Fast dissolving, chewable tablets, and other orally administered dosage forms consist of super-disintegrating agents which shows rapid and quick action. Natural super disintegrating agents in pharmaceutical dosage forms are very effective due to their ecofriendly nature as well as these are biocompatible and biodegradable. These are abundantly and cheaply available from nature.Today the researchers are focusing on naturally available excipients. Keywords: Natural Superdisintegrants, Disintegration, Bioavailability, Biocompatible, Biodegradable.


2018 ◽  
Vol 6 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Pravin Kumar Sharma ◽  
Pankaj Kumar Sharma ◽  
Gajanan N Darwhekar ◽  
Birendra Shrivastava

Nowadays, novel fast dissolving oral films (FDF) have come in existence as an alternative dosage form in comparison with tablet, capsules, syrup and other oral dosage forms with respect to patient convenience and compliance. Fast dissolving oral films are helpful to paediatric and geriatric patients who experience difficulties in swallowing traditional oral solid-dosage forms. The FDF drug delivery systems are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth cavity without need of water or chewing. FDF provide better drug dissolution, faster onset of action, bypassing the first pass metabolism of drugs and thus enhance their oral bioavailability with reduced dosing frequency. These formulations are suitable for cough, cold, sore throat, allergenic conditions, nausea, pain, hypertension and CNS disorders. The present review provides the details about the recent advancement in design and development of oral fast dissolving film.


Author(s):  
Preeti Aggarwal ◽  
Ujjwal Nautiyal ◽  
Rakesh Roshan Mali

These tablets are distinguished from conventional sublingual tablets, lozenges, and buccal tablets which require more than a minute to dissolve in the mouth. In the literature, ODTs also are called orally disintegrating, orodisperse, mouth-dissolving, quick-dissolve, fast-melt, and rapid-disintegrating tablets. Over the past three decades, orally disintegrating tablets (ODTs) have gained much attention as a preferred alternative to conventional oral dosage forms such as tablets and capsules. An ODT is a solid dosage form that disintegrates and dissolves in the mouth (either on or beneath the tongue or in the buccal cavity) without water within 60 seconds or less. The desire of improved palatability in orally administered products has prompted the development of numerous formulations with improved performance and acceptability, and the field has become a rapidly growing area in the pharmaceutical industry. The unique property of mouth dissolving tablet is that they are rapidly disintegrating and/or dissolving and release the drug as soon as they come in contact with saliva, thus obviate the requirement of water during administration. This article reviews the earlier applications and methodologies of taste masking and also emphasize on the recent developments and approaches of bitterness reduction for orally used pharmaceuticals. Apart from the conventional methods of fabrication, this review also provides the detailed concept of some unique patents; technologies developed and marketed formulations of Mouth Dissolving Tablets (MDTs).


Author(s):  
Aher Smita S. ◽  
Saudagar R. B. ◽  
Shinde Mayuri S.

Fast dissolving tablets is one of the most widely accepted dosage forms and also most popular dosage form, especially for pediatric patients because of incomplete development of the muscular and nervous system and a case of geriatric patients suffering from Parkinson’s disorder or hand tremors. Some solid dosage forms like tablets and capsules are present days facing the problems like difficulty in swallowing (dysphagia), resulting in many incidences of non-compliance and making the therapy ineffective. Oral dosage form and oral route are the most preferred route of administration for various drugs have limitations like the first-pass metabolism. Fast dissolving tablets are one of them. FDT have benefits such as accurate dosing, easy portability and manufacturing, good physical and chemical stability and an ideal alternative for pediatric and geriatric patients. Some tablets are designed to dissolve fastly in saliva, within a few seconds, and are true fast-dissolving tablets. Others contain agents to enhance the rate of tablet disintegration in the oral cavity and are more appropriately termed fast-disintegrating tablets, as they may take up to a minute to completely disintegrate.


Author(s):  
NAVEEN TAJ S

The purpose of any selected drug delivery system (DDS) is to deliver drug to target site and to get the desired drug concentration for effective therapy. The main purpose of designing controlled or sustained DDS is to decrease the frequency of dosing and maximizing its efficiency by confining the area of action of the drug to a selected region. It is well-identified that solid oral dosage form, particularly tablets, is the most satisfactory form of delivering medication. In addition, some new variations are emerging such as mini tabs which offer more formulation flexibility. Oral controlled release DDS are classified into two categories like single unit dosage forms which include tablets, capsules, and multiple-unit dosage forms include pellets, granules, or mini tablets. Mini tablets are a new development in solid dosage forms and more beneficial and great substitute for granules and pellets. Mini tablets defined as tablets which are having diameter <3 mm and promising patient friendly drug delivery system and more acceptable in small children’s and old age people as they are easy to swallow and offer therapeutic benefits such as manufactured relatively easy, dose and formulation flexibility, combination release pattern, coating, and less solvent requirement. Dose dumping and local irritation can be avoided using mini tablets. This review highlights the various advantages of mini tablets, manufacturing processes, formulation possibilities, and their challenges.


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