Journal name: World Journal of Pharmaceutical Research
Original article title: Fast dissolving oral films
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 innovative drug delivery system
Original source:
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Deepak Heer, GeetaAggarwal and S.L. Hari Kumar
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Fast dissolving oral films
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
Fast dissolving oral films (FDOFs) represent a novel and advanced form of oral solid dosage, gaining substantial interest in the pharmaceutical industry. These films offer significant advantages such as flexibility, comfort, and rapid dissolution in the mouth, making them particularly suitable for pediatric and geriatric patients who struggle with swallowing traditional tablets or liquids. FDOFs are formulated using hydrophilic polymers, plasticizers, flavors, colors, and sweeteners. This review aims to delve into various aspects of FDOFs including their formulation methodologies, evaluation parameters, and future prospects.
Potential Benefits
Fast dissolving oral films present several key benefits that enhance their practicality and acceptance. Their large surface area promotes rapid disintegration and dissolution in the mouth. They are flexible, less fragile, and thus easier to transport, store, and handle. The films offer ease of administration, especially for patients who are mentally ill, disabled, or non-cooperative, ensuring precision in administered doses. Notably, FDOFs provide rapid drug absorption and faster action, improving bioavailability. They also offer a good mouthfeel and better patient compliance, enhancing the product lifecycle. Limitations such as low dose loading capacity and limited taste masking options can be mitigated by formulating edible films with better dosage capacity and taste-masking techniques.
Technologies for Development of FDOFs
Numerous technologies are employed in the development of FDOFs, encompassing methods such as solvent casting, hot-melt extrusion, and spray drying, among others. One prominent method is the solvent casting technique, where film-forming agents are soaked in a suitable solvent, mixed with other excipients and the drug, then cast on a mold to form the film. Proper consideration is given to the solvent system, liquid rheology, and uniformity of drug content. Another significant method is hot-melt extrusion, which involves blending the API and ingredients, heating them, and then extruding them into films without using solvents, making it suitable for APIs that withstand high temperatures. These advanced methods ensure precise film formation with desired physical and chemical properties.
Physicochemical Evaluation
Evaluating the physicochemical properties of FDOFs is crucial to ensure their efficacy and safety. Key parameters include physical appearance, weight uniformity, thickness, drug content uniformity, folding endurance, surface pH, and tensile strength. The films are visually inspected for color, clarity, flexibility, and smoothness. Weight and thickness are measured using digital balances and screw gauges, respectively. Drug content uniformity involves dissolving the film in a buffer and analyzing it spectrophotometrically. Folding endurance tests the film's ability to withstand repeated folding without breaking. Surface pH, water uptake, percentage moisture loss, and tensile strength further describe the film's robustness and performance under various conditions. In vitro release studies and stability tests are also conducted to assess the film's drug release profile and longevity under different storage conditions.
Conclusion
Fast dissolving oral films offer a revolutionary approach in drug delivery, combining the stability of solid dosage forms with the ease of liquid administration. They hold significant promise, especially for emergency situations like allergic reactions or asthma attacks, where rapid onset of action is crucial. The review highlights the various technological and physicochemical parameters involved in the development of FDOFs, ensuring their efficacy, patient compliance, and potential in the pharmaceutical landscape. As industries continue to leverage this technology, FDOFs are poised to become a staple in both medicinal and over-the-counter products.
FAQ section (important questions/answers):
What are fast dissolving oral films (FDOFs)?
FDOFs are advanced oral solid dosage forms that dissolve rapidly in the mouth, directly reaching systemic circulation. They enhance compliance in pediatric and geriatric patients who have difficulty swallowing tablets or liquids.
What are the key benefits of FDOFs?
FDOFs offer rapid disintegration and dissolution, ease of administration, good stability, improved compliance, rapid absorption, faster action, and precise dosing, making them suitable for patients who find tablets or liquids difficult to take.
What types of drugs can be used in FDOFs?
Various classes of drugs including antiulcer, antiasthmatics, antitussives, expectorants, antihistaminics, and NSAIDs can be formulated as FDOFs, especially those requiring low doses and quicker onset of action.
What are some of the limitations of FDOFs?
FDOFs have low dose loading capacity and limited taste masking options. These drawbacks can be minimized using different taste masking processes and optimizing formulations to incorporate higher doses.
How are FDOFs evaluated for quality?
FDOFs are evaluated for physical appearance, weight uniformity, thickness, drug content uniformity, folding endurance, surface pH, hydration study, moisture loss, tensile strength, in vitro release studies, and stability studies.
What packaging options are available for FDOFs?
FDOFs are usually packaged in single aluminum pouches or blister cards with multiple units. The packaging must protect from environmental conditions, be non-reactive, non-toxic, and meet FDA approvals and tamper-resistant requirements.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Fast dissolving oral films”. 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:
Drug: In the context of fast dissolving oral films (FDOFs), drugs are the active pharmaceutical ingredients (APIs) embedded within the film to provide therapeutic effects. Drugs suitable for these films have low doses and need quicker actions, making this delivery system highly efficient for rapid onset medication.
2) Water:
Water is a crucial solvent in the formulation of FDOFs and is used in various manufacturing techniques, such as the solvent casting method. It helps dissolve hydrophilic polymers and other excipients, creating a uniform film that can dissolve quickly when in contact with saliva.
3) Swelling:
In FDOFs, swelling refers to the film's ability to absorb saliva and expand, facilitating rapid disintegration and release of the drug. Swelling is a key parameter influencing the film's effectiveness, especially in delivering medication quickly through the oral mucosa.
4) Glass:
Glass is mentioned as a carrier material in the spray drying technique for FDOF production. Films are sprayed onto glass or other carriers, dried, and then peeled off to form thin, uniform layers that encapsulate the drug and excipients.
5) Mental disorder:
Mental disorder: FDOFs are a practical drug delivery system for patients with mental disorders who may have difficulty swallowing traditional tablets or capsules. The ease of administration and rapid onset of action make these films suitable for such patient populations.
6) Knowledge:
Knowledge is implicitly important in the development and optimization of FDOFs. Understanding the biopharmaceutical considerations, formulation techniques, and the behavior of active ingredients in different environments are essential for creating effective and reliable oral films.
7) Medicine:
Medicine, in the form of FDOFs, offers a convenient and fast-acting alternative to traditional dosage forms. These films are particularly beneficial for delivering over-the-counter drugs, enhancing the efficiency, dosing accuracy, and patient compliance, especially in pediatric and geriatric medicine.
8) Vomiting:
Vomiting is a condition where FDOFs can be particularly beneficial. The ability of FDOFs to rapidly dissolve and deliver antiemetic drugs directly into the systemic circulation can provide quick relief from nausea and vomiting, offering an advantage over conventional dosage forms.
9) Allergy:
FDOFs can be formulated to provide rapid relief from allergic reactions. These films can contain antihistamines or other anti-allergy drugs and dissolve quickly in the mouth, delivering medication effectively without the need for swallowing tablets or capsules.
10) Anxiety:
FDOFs containing anxiolytic drugs, such as clonazepam, are useful for quick relief in anxiety disorders. These films dissolve rapidly in the oral cavity, allowing the drug to be absorbed quickly into the bloodstream, which is crucial for managing acute anxiety symptoms.
11) Nausea:
Fast dissolving oral films are ideal for treating nausea. The films dissolve in the oral cavity without the need for water, allowing rapid absorption of anti-nausea medication, which is crucial for patients who may find it difficult to swallow traditional pills during bouts of nausea.
12) Desire:
Desire in the context of FDOFs relates to the need for rapid and effective medication delivery. Patients who desire quick relief from symptoms such as pain, allergies, or anxiety benefit from the fast onset of action provided by this innovative drug delivery system.
13) Ulcer:
FDOFs can be used for local drug delivery in the oral cavity, providing relief from conditions such as oral ulcers. By incorporating local anesthetics or anti-inflammatory drugs, these films can offer targeted treatment directly at the ulcer site, improving patient comfort and healing.
14) Blood:
Blood flow in the oral cavity affects the absorption rate of drugs from fast dissolving oral films. Efficient blood supply ensures that the drug, once dissolved and absorbed through the oral mucosa, is quickly transported into systemic circulation, enhancing the onset and efficacy of the medication.
15) Hari (Hāri, Hārin, Harī, Harin):
Hari refers to S.L. Hari Kumar, one of the authors of the study on Fast Dissolving Oral Films. Affiliated with Rayat and Bahra Institute of Pharmacy, his contribution underscores the collaborative effort in researching and advancing innovative drug delivery systems like FDOFs.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Fast dissolving oral films’. Further sources in the context of Science might help you critically compare this page with similair documents:
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