INSIGHTS INTO FORMULATION TECHNOLOGIES AND NOVEL STRATEGIES FOR THE DESIGN OF ORALLY DISINTEGRATING DOSAGE FORMS: A COMPREHENSIVE INDUSTRIAL REVIEW (original) (raw)

Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives

BioMed Research International, 2021

Orally disintegrating tablets (ODTs) rapidly disintegrate or dissolve in the oral cavity without using water. Demand for ODTs has increased, and the field has overgrown in the pharmaceutical industry and academia. It is reported that ODTs have several advantages over other conventional tablets. Since some of them are absorbed from the mouth, pharynx, and esophagus as the saliva passes down into the stomach, in such cases, the bioavailability of the drug improves meaningfully. Furthermore, the immediate release property of ODTs makes them a popular oral dosage form in patients with swallowing challenges, children, and for cases with a need for rapid onset of action. The current review article explains the features of active ingredients and excipients used in the formulation of ODTs, discusses multiple ODT formulation and preparation techniques with their merits and demerits, and also, offers remedies for problems associated with ODTs. Moreover, quality control steps and required cons...

Orally Disintegrating Tablets: A Review

Drug delivery systems are becoming increasingly sophisticated as pharmaceutical scientists acquire a better understanding of the physicochemical and biochemical parameters pertinent to their performance. Over the past three decades, orally disintegrating tablets (ODTs) have gained considerable attention as a preferred alternative to conventional tablets and capsules due to better patient compliance. ODTs are solid dosage forms containing medicinal substances which disintegrate rapidly, usually in a matter of seconds, when placed on the tongue. Products of ODT technologies entered the market in the 1980s, have grown steadily in demand, and their product pipelines are rapidly expanding. New ODT technologies address many pharmaceutical and patient needs, ranging from enhanced life-cycle management to convenient dosing for paediatric, geriatric, and psychiatric patients with dysphagia. This has encouraged both academia and industry to generate new orally disintegrating formulations and technological approaches in this field. The aim of this article is to review the development of ODTs, challenges in formulation, new ODT technologies and evaluation methodologies, suitability of drug candidates, and future prospects.

Fast disintegrating tablets: Opportunity in drug delivery system

Fast disintegrating tablets (FDTs) have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Oral drug delivery remains the preferred route for administration of various drugs. Recent developments in the technology have prompted scientists to develop FDTs with improved patient compliance and convenience. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. The popularity and usefulness of the formulation resulted in development of several FDT technologies. FDTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. FDTs or orally disintegrating tablets provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. This review describes various formulations and technologies developed to achieve fast dissolution/dispersion of tablets in the oral cavity. In particular, this review describes in detail FDT technologies based on lyophilization, molding, sublimation, and compaction, as well as approaches to enhancing the FDT properties, such as spray drying and use of disintegrants. In addition, taste-masking technologies, experimental measurements of disintegration times, and dissolution are also discussed.

Fast Disintegrating Drug Delivery Systems: A Review with Special Emphasis on Fast Disintegrating Tablets

REVIEW ARTICLE, 2013

The development of pharmaceutical technology in past years has presented the development of alternative dosage forms for patients who may have difficulty in swallowing of conventional tablets. Fast disintegrating drug delivery systems (FDDDSs) are the system which disintegrate and release the active ingredient quickly and that do not require water to aid swallowing. Among the FDDDSs, the fast disintegrating tablets (FDTs) are the more acceptable form of drug delivery system because of its convenience of self-administration and compactness. In the conditions (pediatric and geriatric patients, difficulty in swallowing, uncooperative patients), where the traditional tablets and capsules administration is inconvenient, the fast dissolving/disintegrating tablets are perfect alternative. According to European Pharmacopoeia, the FDT disintegrate in less than three minutes. The basic approach used in development of FDT is the use of superdisintegrants which provide instantaneous disintegration and thereby releasing the drug in saliva. Taste of the drug is one of the most important parameters which should be taken in account for the development of FDTs. Oral administration of bitter drugs with an acceptable degree of palatability can be achieved by taste masking approach. This communication reviews the applications and technologies involved in formulation of FDDDSs specially focused on FDTs.

Development of Fast Disintegration Tablets As Oral Drug Delivery System-A Review

Fast disintegrating tablets (FDTs) have received increasing demand from the last few years and the field has become a rapidly growing field in the pharmaceutical industry. Fast disintegrating tablets (FDTs) are those solid doses form which when put on the tongue gets rapidly dissolved, releasing the drug within a few second without need of water. The development of FDTs have been formulated for paediatric, geriatric and bedridden patients and for active patients who are busy and travelling and may not have access to water. Such formulation provide an opportunity for product line extension in the many elderly persons will have difficulties in taking conventional oral doses forms (viz, solution suspensions tablet and capsules) because of hand tremors and dysphagia. This article focused on ideal requirements, need for development of FDTs, challenges in formulations, suitability of drug candidates superdisintegrants employed, various technologies developed for FDTs. Evaluation methods, and various marketed products.

Oral Disintegrating Tablets – A Current Review

The patient compliance lies in the ease with which the drug is delivered into the body without affecting its efficacy and without causing any inconvenience to the patient. For the patients who have a problem in swallowing, mainly the children and the old, oral disintegrating tablets (ODT) is a good choice. The products are designed to disintegrate or dissolve rapidly on contact with saliva, thus eliminating the need to chew the tablet, swallow an intact tablet, or take the tablet with liquids. Design of an ODT requires enough porosity inside the tablet for fast dissolving or fast melting while maintaining the mechanical strength of the tablet. Processing techniques such as freeze-drying, molding and sublimation, spray drying, direct compression followed by vacuum drying can be used to formulate ODTs. Formulation techniques such as incorporation of high levels of disintegrant, extragranular microparticulate active in conjunction with an effervescent agent, highly compressible excipients, aminoacid as a disintegrant, amorphous ingredient, hydrophilic waxy binder, combination of ion exchange resin and cyclodextrin, combination of the superdisintegrants and sublimation technique, specialized excipients such as effervescent couple and highly micronized agents. Various studies carried out by several scientists in the world are presented in this review article.

Orally disintegrating tablets : formulation, preparation techniques and evaluation

2011

Oral delivery is currently the gold standard in the pharmaceutical industry where it is regarded as the safest, most convenient and most economical method of drug delivery having the highest patient compliance. Formulation of a convenient dosage form for oral administration, by considering swallowing difficulty especially in case of geriatric and pediatric patient leads to poor patient compliance. To troubleshoot such problems a new dosage form known as orally disintegrating tablet (ODT), has been developed which rapidly disintegrate & dissolve in saliva and then easily swallowed without need of water which is a major benefit over conventional dosage form. In addition, patients suffering from dysphasia, motion sickness, repeated emesis and mental disorders prefer such preparation because they cannot swallow large quantity of water. Further, drugs exhibiting satisfactory absorption from the oral mucosa or intended for immediate pharmacological action can be advantageously formulated ...

Controlled Release Orally Disintegrating Tablets : A Review T Review

2014

An Orally disintegrating tablet (ODT) is a solid dosage form that disintegrates and dissolves in the mouth within 30 seconds or less without aid of water. This novel dosage form not only provides patient compliance but also allow manufacturers to extend the patent protection. In combination with modified release technology ODTs will continue to provide enhanced therapeutic and commercial benefits. Combining ODTs with specialized functional polymers and coating processes can lead to ODTs with sustained-, modifiedand customized release profiles. It is even possible to combine different drugs with different release patterns into a single dosage form. Typical of these approaches are microencapsulation and multi-particulate coating technology, which allow formulator to create modified release polymer layer around API particles. These particles are flexible enough for compression without breakage or loss of the modified release properties and small enough to provide good mouth feel. Futur...

A Review On-Recent Advancement in the Development of Rapid Disintegrating Tablet

ijlpr.com

Recent advances in novel drug delivery (NDDS) aims to enhance safety and efficacy of drug molecule by formulating a convenient dosage form for ease of administration and to achieve better patient compliance. In the recent trend one such approach the development of rapid disintegrating tablets formulation is emerging and gaining popularity because it is easy to administer and leads to better patient compliance. These dosage forms are placed in the mouth, allowed to disperse or dissolve in the saliva. They release the drug as soon as they come in contact with the saliva, thus obviating the need for water during administration. The aim of this article is to review the progress of the evolving technologies and super disintegrating agents in the formulation, manufacturing and evaluation of these tablets. This article also discusses the new evaluation methodologies for these rapid disintegrating tablets. Various modifications in the conventional evaluation and use of specialized instruments are found to be essential in the testing of these dosage forms. In the present review the formulation techniques and different technologies are discussed.

Oral Disintegrating Tablets: A Review

International Journal of Pharma Research & Review, 2016

In the design of dosage forms, comforts of drug administration and patient conformity have considerable prominence. Recent and rising technologies can manufacture robust, versatile tablets with extraordinary taste masking and controlled release. Orally disintegrating tablets (ODTs) are solid dosage forms that disintegrate in the mouth in less than 60 s, and are thus swallowed without the need for water. Rapid disintegration of tablet cause quick dissolution and thus fast onset of action. ODTs are suitable dosage form for special populations like pediatrics, geriatrics, psychotic, dysphagic, bedridden patients, unconscious patients, young patients with under developed muscular and nervous system, patients with hand tremors problems and frequent traveller patients. It provides good stability, accurate dosing, easy manufacturing, decreased packaging size; self-administration is possible during the journey, as water is not required. ODTs are an economical method of drug delivery. ODTs a...