Orodispersible film dosage form

a review

| Posted in: Science

Journal name: World Journal of Pharmaceutical Research
Original article title: Orodispersible film dosage form
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: a review

Original source:

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Author:

Dnyaneshwar H.R., Wale K.K., Sayyed S.F., Dr. Chaudhari S.R.


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Orodispersible film dosage form

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

Orodispersible dosage forms, particularly orodispersible films (ODFs), represent a significant innovation in drug delivery systems. They are especially beneficial for pediatric and geriatric populations who may struggle to swallow tablets or consume liquids. Unlike traditional oral dosage forms, orodispersible films dissolve or disintegrate rapidly in the mouth, providing a convenient, non-invasive method to deliver medication without the need for water or risk of choking. This article discusses the formulation, advantages, disadvantages, methods of preparation, and potential applications of ODFs, as well as their significance in addressing various medical needs.

Importance of Orodispersible Films

Orodispersible films are characterized by their ability to rapidly dissolve or disintegrate when placed in the oral cavity. They eliminate the problems associated with large tablets and the requirement for water, making medication administration easier and safer for individuals who may be at risk of choking. ODFs are constructed using hydrophilic polymers, which enhance disintegration and solubility, allowing for quick absorption through the mucosal membranes. The polymers, combined with other excipients such as plasticizers, sweeteners, and flavoring agents, help create a pleasant user experience while maintaining effective drug release and bioavailability.

Advantages and Disadvantages

The advantages of orodispersible films include accurate dosing, rapid onset of action, and improved patient compliance due to their small size and ease of handling. They provide an alternative that avoids the potential for gastric degradation, significantly enhancing the bioavailability of certain therapeutic agents. However, there are inherent disadvantages, such as the hygroscopic nature of the films requiring careful storage, limitations on drug dosage (with large doses difficult to formulate), and the possibility of stability issues necessitating specialized packaging.

Methods of Preparation

Orodispersible films can be manufactured using various methods, including solvent casting, hot melt extrusion, and rolling methods. The solvent casting method allows for uniform thickness and clarity but requires solubility of the polymers in volatile solvents. In contrast, hot melt extrusion avoids solvents entirely, although it may pose risks like thermal degradation of sensitive components. The choice of preparation method significantly affects the film's final properties, such as dissolution rate and mechanical strength.

Conclusion

Orodispersible films embody a promising alternative to traditional oral dosage forms, addressing the needs of diverse patient populations. Their formulation involves meticulous selection of polymers and excipients to achieve the desired performance characteristics. As research into this emerging delivery system continues to evolve, orodispersible films will likely find broader applications, potentially transforming how certain medications are administered and enhancing therapeutic outcomes across various medical fields.

FAQ section (important questions/answers):

What are the advantages of orodispersible films over traditional tablets?

Orodispersible films eliminate choking risks, require no water for swallowing, enhance dosing accuracy, and offer rapid onset of action, making them more convenient than traditional tablets.

What types of polymers are used in orodispersible films?

Commonly used polymers include Pullulan, Gelatin, Sodium Alginate, Pectin, and Chitosan, which contribute to the film's disintegration and drug release properties.

How are orodispersible films prepared?

Orodispersible films can be prepared using methods such as solvent casting, hot melt extrusion, and others that ensure uniformity and desired film properties.

What is the typical composition of orodispersible films?

Orodispersible films typically comprise drug, water-soluble film forming polymers, plasticizers, sweetening agents, flavoring agents, and saliva stimulating agents.

What are the limitations of orodispersible films?

Limitations include challenges in formulating high-dose drugs, sensitivity to humidity, and potential bitterness of certain drugs which may require masking strategies.

Which drugs are suitable for orodispersible film formulations?

Suitable drug categories include anti-emetics like Ondansetron, anti-epileptics like Diazepam, and various others in lower doses to ensure effective formulation.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Orodispersible film dosage form”. 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 refers to any chemical substance used for treatment, prevention, or diagnosis of diseases. In the context of orodispersible films, the selection of drugs is crucial as their delivery method must ensure rapid absorption and efficacy, particularly for patients who may have difficulty swallowing traditional forms like tablets.

2) Dnyaneshwar (Dnyaneshvar):
Dnyaneshwar is the name of the primary author of the study on orodispersible films, indicating his contributions to the research. His expertise and collaborative efforts highlight the importance of teamwork in advancing pharmaceutical technologies and addressing patient needs, particularly focusing on improving drug delivery for vulnerable populations.

3) Water:
Water is a critical component in the formulation of orodispersible films. As a solvent, it aids in dissolving polymers and active pharmaceutical ingredients, facilitating the film formation process. Additionally, water's role is pivotal during the film's disintegration in the oral cavity, ensuring effective and rapid drug absorption.

4) Vomiting:
Vomiting is a physiological response often associated with nausea. In the context of orodispersible films, effective formulations can deliver antiemetic drugs swiftly to alleviate vomiting, particularly in pediatric or geriatric patients. This capability exemplifies the utility of innovative drug delivery systems in addressing various medical symptoms quickly.

5) Nausea:
Nausea describes the sensation of discomfort often preceding vomiting. It is a common side effect of numerous conditions and treatments, such as chemotherapy. Orodispersible films developed for antiemetics can offer rapid relief from nausea, enhancing patient comfort and compliance due to their ease of administration.

6) Surface:
Surface refers to the outer layer of the orodispersible film, which plays a critical role in the film's interaction with saliva and mucosal membranes. The surface properties influence the film's disintegration rate and drug release profile, thereby affecting the overall effectiveness of the drug delivery system.

7) Table:
Table refers to a methodical presentation of data. In the review, tables comparing orodispersible films and tablets highlight the advantages of films over traditional tablets, such as quicker dissolution and higher patient compliance. This data-driven approach aids in decision-making for pharmaceutical formulations.

8) Food:
Food is a significant consideration in pharmacology, especially in drug absorption and efficacy. Drugs formulated as orodispersible films can be taken without the need for food or water, which improves usability and patient compliance. The ability to avoid interacting with food digestive processes is essential for certain drugs.

9) Chemotherapy:
Chemotherapy is a treatment for cancer that often induces nausea and vomiting as side effects. The review highlights the role of orodispersible films as a means to deliver antiemetics rapidly and effectively to patients undergoing chemotherapy, thus improving their quality of life during treatment.

10) Colouring (Coloring):
Coloring refers to the use of coloring agents in orodispersible films that enhance their visual appeal. Such agents contribute to the overall acceptance of the medication, particularly in pediatric populations, making medications more palatable and encouraging adherence to prescribed treatments.

11) Bitter:
Bitter describes a common taste associated with many medications. In formulating orodispersible films, special attention is given to taste masking techniques essential for improving patient compliance, especially in children who may refuse medication due to unpleasant flavors associated with bitterness.

12) Nature:
Nature in this context can refer to the intrinsic properties of materials used in pharmaceutical formulations. Understanding the chemical and physical nature of polymers, active pharmaceutical ingredients, and excipients is critical for developing effective orodispersible films that meet desired performance characteristics.

13) Fear:
Fear, particularly in the context of choking, is a significant concern among patients, especially children and the elderly. Orodispersible films alleviate this fear by offering a dosage form that dissolves quickly in the mouth without the need to swallow, enhancing the overall patient experience.

14) Pain (Paiṇ):
Pain is a symptom often managed using pharmacological interventions. Orodispersible films can provide rapid delivery of analgesics for urgent relief, showcasing their utility in treating acute pain situations effectively. This method of delivery allows for quicker therapeutic action compared to traditional dosage forms.

15) Maharashtra (Mahārāṣṭra, Maha-rashtra):
Maharashtra is a state in India where the study on orodispersible films was conducted. This geographic context may reflect local pharmaceutical needs, resources, and research activities, contributing to the global understanding of drug delivery systems and their adaptations to diverse populations.

16) Ahmednagar:
Ahmednagar is a city in Maharashtra, India, associated with Amrutvahini College of Pharmacy, where the research team is based. This locality contributes to the academic and scientific workforce focused on enhancing pharmaceutical technology and improving healthcare outcomes through innovative drug delivery systems.

17) Swallowing:
Swallowing presents challenges for certain populations, including children and the elderly, who may struggle with traditional oral medications. Orodispersible films eliminate the swallowing requirement, providing a safer and easier alternative for medication administration, thereby improving compliance and patient comfort.

18) Quality:
Quality in the formulation of orodispersible films is crucial, as it determines the efficacy, safety, and overall patient satisfaction with the medication. Various parameters, such as disintegration time, drug content uniformity, and mechanical strength, are assessed to ensure the product meets stringent pharmaceutical standards.

19) Gelatin:
Gelatin is one of the water-soluble polymers mentioned in the study, often used due to its film-forming capabilities. Its inclusion in orodispersible films enhances flexibility and performance, making it a key ingredient in achieving the desired characteristics for effective drug delivery.

20) Medium:
Medium, referring to the environment where the orodispersible films are evaluated, such as in dissolution tests, is crucial for assessing the films' performance. The choice of medium affects the drug's release profile and absorption characteristics, impacting the overall therapeutic effectiveness.

21) India:
India plays a significant role in pharmaceutical research and development, providing a diverse landscape for studying drug delivery systems. The country's unique patient demographics necessitate innovative solutions like orodispersible films to address specific health challenges faced by various population groups.

22) Study (Studying):
Study denotes the research undertaken to explore the formulation and efficacy of orodispersible films. This investigation encompasses various aspects, including polymer selection, drug incorporation, and sensory evaluations, contributing invaluable insights into improving patient-centered care in drug administration.

23) Male (Mālē):
Male indicates a demographic that can be affected differently by various medications. Understanding gender differences in drug metabolism and efficacy is vital in pharmaceutical development, particularly in creating tailored orodispersible films that address specific health concerns prevalent among male patients.

24) Rich (Ṛch):
Rich refers to the structural composition of the oral mucosa, which can influence drug absorption. The richness of lipid content and the permeability of the mucosal membrane must be considered when formulating orodispersible films to ensure effective drug delivery to the systemic circulation.

25) Line:
Line can signify a methodical progression in research or formulation development. In the context of pharmaceutical formulations, establishing a clear line of procedures from development to evaluation is critical in ensuring robust data collection and analysis for quality assurance in product efficacy.

26) Observation:
Observation refers to the detailed evaluation processes conducted during the formulation assessments of orodispersible films. Documenting attributes like physical characteristics, disintegration times, and sensory experiences significantly contributes to understanding the viability and potential of the developed formulations.

27) Performance:
Performance evaluates how effectively orodispersible films deliver the intended drug. Key metrics for performance include disintegration time, bioavailability, and sensory acceptance. Understanding performance parameters is vital for refining formulations and enhancing patient compliance in therapeutic settings.

28) Container:
Container denotes the packaging used for storing or presenting orodispersible films. Proper containment ensures stability and efficacy, protecting against factors like moisture that may affect the film’s integrity. The choice of containers impacts the product's shelf life and user experience.

29) Cinnamon:
Cinnamon, as a flavoring agent, enhances the palatability of orodispersible films. Its pleasant taste can counteract bitterness in pharmaceutical formulations, making medications more acceptable, especially to pediatric populations, where flavor acceptance plays a significant role in treatment adherence.

30) Medicine:
Medicine encompasses the broad category of substances used to treat, diagnose, or prevent illness. In this context, the focus is on orodispersible films as a novel method of drug delivery, offering advantages in terms of speed, ease of use, and patient satisfaction in medication regimes.

31) Liquorice (Licorice):
Licorice, noted for its sweet flavor, is used in formulations to mask unpleasant tastes of active pharmaceutical ingredients. Its incorporation can significantly enhance the appeal of medicines, particularly in orodispersible film formats, which aim to improve patient compliance and overall user experience.

32) Heating:
Heating refers to the temperature-controlled processes involved in the preparation of orodispersible films. Properly managing heating is essential in achieving the desired consistency and film characteristics, ensuring that the active ingredients remain stable and effective throughout the formulation process.

33) Account:
Account refers to the detailed documentation and consideration of various factors in the formulation process. Properly accounting for variables such as ingredient interactions, physical characteristics, and patient demographics ensures the development of effective and user-friendly orodispersible films.

34) Allergy:
Allergy signifies the immune response some individuals have toward certain substances, which may include medications. It is essential for pharmacists and formulators to consider potential allergic reactions when designing orodispersible films, ensuring patient safety and tolerability in drug administration.

35) Cancer:
Cancer is a serious disease often requiring comprehensive treatment strategies, including the use of antiemetic medications to manage side effects such as nausea. Orodispersible films can provide rapid relief to patients undergoing treatment for cancer, improving their therapeutic experience and adherence to medication.

36) Animal:
Animal considerations in pharmaceutical research include ensuring that studies comply with ethical standards for animal use. In the context of drug formulation, knowledge about pharmacokinetics, metabolism, and systemic absorption can help replicate human responses in orodispersible film development.

37) Dish (Diś):
Dish represents the container used for testing formulations, such as during disintegration studies of orodispersible films. The choice of dish type can influence experimental outcomes and the reliability of results, emphasizing the need for standardized methodologies in formulation testing.

38) Tree:
Tree symbolizes the natural source of many ingredients or excipients used in pharmaceutical formulations, including plant-based compounds. The utilization of tree-derived substances can play a role in enhancing the efficacy and safety of orodispersible films, reflecting a trend toward more natural product formulations.

39) Fire:
Fire can metaphorically represent the precision and careful control needed in the thermal aspects of the film preparation process. Striking a balance in temperature during heating is crucial to prevent degradation of active ingredients and ensure a successful formulation of orodispersible films.

40) Hand:
Hand symbolizes the tactile interaction patients have with orodispersible films when administering them. Easy handling and use are vital features of these films, aimed at ensuring that patients, including children and the elderly, can easily and safely manage their medication without discomfort.

41) Sour:
Sour refers to the taste profile that some medications may exhibit. Offering medications that are not only effective but also palatable is crucial, prompting formulators of orodispersible films to consider sour taste masking strategies to improve patient compliance and overall acceptability of treatment.

42) Salt (Salty):
Salt can indicate saline or ionic content that may be relevant in developing formulations that enhance flavor or stability. In the context of orodispersible films, understanding the role of salt is important for tailoring the delivery system to improve the acceptance of medications by patients.

43) Pur (Pūr):
Poor signifies the challenges and limitations faced in the development of certain medications, particularly those with undesirable taste or adverse effects. The emphasis on creating orodispersible films is to address such issues, ensuring improved patient adherence and therapeutic outcomes despite the initial challenges.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘Orodispersible film dosage form’. Further sources in the context of Science might help you critically compare this page with similair documents:

Physical appearance, Nausea and vomiting, Method of preparation, Flavoring agent, Methods of preparation, Drug Absorption, Drug delivery system, Active ingredient, Geriatric population, Physicochemical properties, Paediatric population, Weight variation, Hygroscopic nature, Disintegration time, Therapeutic areas, Ascorbic acid, Systemic circulation, Patient compliance, Tensile strength, Taste-masking, Active pharmaceutical ingredient, First pass effect, Coloring agent, Antiemetic therapy, Sweetening agent, Rotavirus vaccine, Gastrointestinal disorder, Physical characteristic.

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