Journal name: World Journal of Pharmaceutical Research
Original article title: Orally disintegrating tablet
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Subtitle: an overview
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Prasannajeet P. Deshmukh, K.S.Salunkhe, S.R.Chaudhari, and G.R.Pawbake
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Orally disintegrating tablet
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Orally Disintegrating Tablets (ODTs) have gained significant traction in the pharmaceutical industry over the past few decades due to their unique properties that enhance patient compliance. These tablets disintegrate and dissolve rapidly upon contact with saliva, eliminating the need for water during administration. They are particularly advantageous for pediatric and geriatric populations who often face challenges in swallowing traditional tablets and capsules. This review explores the ideal characteristics, technologies involved in the formulation of ODTs, their advantages and disadvantages, as well as evaluation tests and marketed formulations.
Unique Characteristics of ODTs
ODTs must exhibit specific ideal properties to ensure effective administration. These include the ability to dissolve within seconds without water, high drug loading capacity, compatibility with taste masking agents, and a pleasing mouth feel. Furthermore, they should leave minimal residue in the mouth and maintain structural integrity through manufacturing and handling processes. Stability in varying environmental conditions is also crucial. ODTs reduce the risk of choking or suffocation, making them safer alternatives for sensitive populations. In addition, they can provide rapid onset of action, which is beneficial in situations requiring immediate relief, such as motion sickness or sudden allergic reactions.
Formulation Challenges and Advantages
Formulating ODTs presents unique challenges, primarily in achieving the right balance of porosity and strength. The incorporation of superdisintegrants and excipients that promote quick dissolution is critical. Many common excipients and techniques are employed, including sublimation, lyophilization, and direct compression. The advantages of ODTs are vast; they facilitate administration in people who cannot swallow pills, provide rapid drug action, offer ease of use for those without access to water, and enhance bioavailability through pre-gastric absorption. The positive patient experience is further supported by improved taste masking.
Technologies in ODT Manufacturing
Various technologies are utilized for the development of ODTs, which enhance their functionality and patient appeal. Techniques like freeze-drying, molding, and spray drying are employed to create porous structures that dissolve rapidly. Innovations like Zydis and Orasolv technologies focus on taste masking and effervescence, respectively, while methods such as mass extrusion and nanonization reduce particle size for improved disintegration. Each technology offers distinct benefits and some challenges regarding stability and mechanical strength, influencing the final product’s performance in achieving rapid dissolution.
Conclusion
In conclusion, ODTs represent an innovative approach to drug delivery, offering substantial benefits over conventional dosage forms by improving patient compliance and efficacy. Their ideal characteristics and technological advancements in formulation contribute to their growing acceptance, especially among pediatric and geriatric populations. As pharmaceutical companies continue to develop and refine ODTs, their popularity is expected to increase, resulting in a broader range of formulations available on the market. The focus on patient experience and the ability to provide rapid therapeutic effects establishes ODTs as a crucial advancement in pharmaceutical science.
FAQ section (important questions/answers):
What are orally disintegrating tablets (ODTs)?
Orally disintegrating tablets (ODTs) dissolve quickly in the mouth, releasing medication without needing water. They are especially beneficial for individuals with swallowing difficulties, such as children and the elderly.
What are the advantages of ODTs?
ODTs improve patient compliance by eliminating swallowing difficulties and providing rapid onset of action. They also offer accurate dosing, enhanced bioavailability, and convenience for patients who may not have access to water.
What challenges are faced in ODT formulation?
Formulating ODTs requires balancing porosity for quick disintegration with mechanical strength to withstand handling. Maintaining low sensitivity to moisture is also crucial for ensuring stability.
What technologies are used to create ODTs?
Various technologies like lyophilization, sublimation, and direct compression are employed to create ODTs. Each method aims to enhance the tablet's disintegration and dissolution properties.
What are the limitations of ODTs?
ODTs can be hygroscopic, fragile, and require special packaging. They may also have limited mechanical strength and can only accommodate small doses of certain medications.
How are ODTs evaluated for quality?
ODTs undergo several evaluations including hardness, disintegration time, and dissolution tests. These assessments ensure they meet required standards for consistency, effectiveness, and patient acceptance.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Orally disintegrating tablet”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
A drug is a substance used to diagnose, treat, or prevent disease. In the context of orally disintegrating tablets (ODTs), the drug's characteristics, such as solubility and bioavailability, are crucial for ensuring effective therapeutic outcomes and patient compliance, particularly in populations that struggle with swallowing pills.
2) Water:
Water is often required for the dissolution and disintegration of tablets. However, ODTs are designed to dissolve without water, making them accessible for patients, especially children and the elderly, who may not always have fluid readily available. The use of saliva for disintegration is a key feature of ODTs.
3) Powder:
Powder refers to the physical state of the drug and excipients used in the formulation of ODTs. The particle size and characteristics of the powder affect the tablet's disintegration, dissolution, and bioavailability. Properly formulated powders enable the rapid release of the drug when the tablet comes in contact with saliva.
4) Pur:
In the context of ODTs, 'poor' often describes inadequate characteristics such as flow properties, tablet strength, or stability. If a formulation is deemed poor, it may lead to increased disintegration time or suboptimal patient experiences, thus undermining the primary purpose of enhancing patient adherence to medication regimens.
5) Swallowing:
Swallowing difficulty is a common issue among various patient populations, particularly the elderly or those with dysphagia. ODTs were designed to address this challenge, enabling patients to take their medication without the need to swallow large tablets or capsules, thereby improving medication adherence and comfort.
6) Surface:
The surface properties of tablets play a significant role in their disintegration and dissolution rates. A tablet's surface area affects how quickly it can absorb moisture from saliva, thus impacting the onset of drug release. Techniques to enhance surface characteristics are key in formulating effective ODTs.
7) Swelling:
Swelling refers to the expansion of superdisintegrants upon contact with liquids, which facilitates the breakup of the tablet. This is crucial for ODT formulations, as effective swelling means faster disintegration in the mouth, enabling rapid drug release and absorption, providing a quicker therapeutic effect.
8) Medium:
Here, 'medium' can refer to the surrounding environment, such as saliva or water, in which the ODT is supposed to dissolve. The choice of medium influences the disintegration and dissolution performance of the tablet, which are vital for determining the appropriate bioavailability of the drug.
9) Bitter:
Bitter refers to the unpleasant taste of many active pharmaceutical ingredients. ODT formulations often require taste-masking techniques to improve patient compliance, especially for pediatric populations. The success of an ODT can hinge on its palatability, achieving a balance between effective drug delivery and customer acceptance.
10) India:
India is emerging as a significant market in the pharmaceutical industry, particularly in the context of generic drugs and innovative drug delivery systems like ODTs. The country's diverse population presents unique opportunities and challenges for developing effective dosage forms tailored to various demographic needs.
11) Candy:
Candy may refer to the appealing taste or texture that ODTs aim to mimic, making medication more palatable, especially for children. The formulation of ODTs can incorporate sweeteners or flavoring agents akin to candy to enhance the overall consumer experience and improve adherence to therapy.
12) Table:
The term 'table' in this context refers to the orally disintegrating tablets themselves. ODTs are solid dosage forms specifically engineered to dissolve rapidly in the mouth, providing a different delivery method compared to traditional tablets, which often require water for ingestion.
13) Heating:
Heating is relevant in the context of certain formulation techniques like melt granulation and phase transition processes. Controlled heating can enhance the bonding between particles in tablets, thereby improving tablet hardness and stability while also facilitating the disintegration and dissolution process.
14) Cotton:
Cotton refers to the unique spinning mechanism used in the cotton candy process during ODT formulation. This process creates a fibrous structure that mimics the texture and mouthfeel of cotton candy, optimizing the tablet's disintegration properties while also potentially enhancing the taste experience.
15) Sugar:
Sugar plays a dual role in ODT formulations, serving as a sweetening agent for taste masking and as a bulking agent to improve mouthfeel. Sugar-based excipients also help facilitate quicker dissolution and contribute to the overall patient acceptance of the final dosage form.
16) Substance:
Here, 'substance' refers to the drug or active ingredient present in ODTs. The characteristics of the active substance, including solubility and stability, significantly impact the tablet's performance, particularly in achieving the desired therapeutic effects upon oral administration.
17) Filling (Filled):
Filled denotes the process of incorporating the active drug and excipients into ODT molds during manufacturing. Proper filling techniques are essential for achieving the desired tablet weight, hardness, and performance, directly influencing the drug's release characteristics once administered to patients.
18) Gelatin:
Gelatin is often used in ODT technology as a gelling or binding agent. It can contribute to the tablet's structure, enhancing stability and taste masking properties. Gelatin's solubility in saliva helps facilitate the disintegration of tablets, allowing for the rapid release of the drug.
19) Nature:
Nature refers to the inherent characteristics of the materials used in the formulation of ODTs, including both active substances and excipients. Understanding their physical and chemical nature is essential for predicting how they will behave during tablet manufacturing and in vivo disintegration and drug release.
20) Transformation (Transform, Transforming):
Transformed relates to the process of changing the state or structure of the ingredients involved in ODT formulations. This may involve changes through methods such as lyophilization or sublimation, which help create the unique properties of ODTs that facilitate rapid dissolution in the mouth.
21) Perception:
Perception in this context refers to how patients view and experience the medication, particularly in terms of taste and ease of administration. A positive perception of ODTs can significantly enhance patient compliance and willingness to adhere to a prescribed treatment regimen.
22) Swallowed:
Swallowed describes the action that is avoided when using ODTs. Unlike traditional tablets that must be swallowed whole, ODTs disintegrate in the mouth, allowing for easier and more comfortable administration. This characteristic is particularly advantageous for patients with swallowing difficulties.
23) Crushing:
Crushing refers to the mechanical process used to determine the hardness and strength of tablets. An appropriate crushing strength ensures that tablets can withstand handling and transportation, while also allowing for effective disintegration when placed in the mouth for rapid drug release.
24) Camphor:
Camphor is mentioned as an inert solid used in sublimation processes for creating porous tablets. This substance helps achieve the desired tablet characteristics, such as disintegration and dissolution, making it integral to formulating effective orally disintegrating tablets that perform well in real-world conditions.
25) Pouring:
Pouring pertains to the method of creating blends of powders prior to tablet compression. Successful pouring techniques are crucial for the uniform distribution of drug and excipients in the formulation, ensuring consistent performance across batches of orally disintegrating tablets.
26) Company:
The term 'company' refers to pharmaceutical manufacturers that develop and produce ODTs. Companies play a key role in advancing ODT technology through research, formulation innovations, and bringing products to market that meet both regulatory standards and patient needs.
27) Plough:
In this context, Plough refers to a company (Schering-Plough) known for its pharmaceutical products. Collaboration with established companies can lead to the successful development and distribution of ODTs, leveraging their expertise in formulation and market access within the pharmaceutical industry.
28) Field:
Field refers to the area of pharmaceutical research and development focused on innovative dosage forms like ODTs. Advancements in this field aim to enhance patient compliance and therapeutic outcomes, addressing the unique challenges posed by traditional medication formats.
29) Study (Studying):
Study involves research aimed at understanding the efficacy and practical applications of ODTs within patient populations. Clinical studies help establish the real-world benefits of ODT formulations, contributing to evidence-based practices in medication administration.
30) King:
King, in this context, could refer to 'King of Prussia,' relating to Elan Pharmaceuticals' nanocrystal technology. This geographic identifier emphasizes the role of specific companies in advancing ODT technology and exemplifies how regional pharmaceutical hubs contribute to innovation.
31) Heap:
Heap refers to the pile or accumulation of powdered ingredients prior to their processing into ODTs. The characteristics of the heap, including flowability and compressibility, are important for efficient tablet manufacturing and impact the tablet's final characteristics.
32) Pain:
Pain describes the discomfort often experienced by patients when taking traditional oral medications, especially those large pills which require swallowing. ODTs are developed to eliminate the pain associated with conventional delivery routes, representing a more patient-friendly alternative while improving adherence.
33) Hand:
Hand signifies manual dexterity or control during the tablet manufacturing process. Proper handling techniques are crucial in ODT production to maintain tablet integrity and ensure consistency in the final product, influencing both its performance and patient acceptance.
34) Post:
Post may refer to the after-effects or outcomes following the administration of ODTs. After the tablet has dissolved, the expected therapeutic results occur, warranting a focus on how formulation impacts both clinical effectiveness and patient satisfaction.
35) Life:
Life encompasses the broader context wherein ODTs serve to improve the quality of life for patients, particularly those who face challenges with swallowing. By facilitating easier medication administration, ODTs can contribute to better health outcomes and overall patient wellbeing.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Orally disintegrating tablet’. Further sources in the context of Science might help you critically compare this page with similair documents:
Ideal characteristics, Environmental condition, Comprehensive review, Dysphagia, Bioavailability, Drug delivery system, Patient acceptance, Hygroscopic nature, Disintegration time, Compressibility index, Hausner's ratio, Crushing strength, Friability test, Patient compliance, Active medicament, Direct compression method, Taste-masking, Mechanical strength, Angle of repose, Wet granulation, Dry granulation, Toxic metabolite, Difficulty in swallowing.
Concepts being referred in other categories, contexts and sources.
Dryness of the mouth, Size and shape.