Bilayer tablet-technology- a review
Journal name: World Journal of Pharmaceutical Research
Original article title: Bilayer tablet-technology- a review
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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Gajanan Venkatrao Pulgamwar, Ram S. Pentewar, Rohit U. Bharti, B. K. Sugave and Saroja P. Adepawar
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Bilayer tablet-technology- a review
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
1) Introduction
Bi-layer tablets represent a significant advancement in drug delivery systems, offering various advantages in the pharmaceutical field. As many pharmaceutical companies seek to develop these innovative formulations, the technology allows for a controlled and sequential release of two drugs, effectively addressing incompatibilities and enhancing therapeutic efficacy. This review encompasses the rationale, manufacturing processes, quality, and regulatory requirements of bi-layer tablet technologies, alongside recent developments, while also addressing the challenges associated with them.
2) Sequential Drug Release
One of the critical features of bi-layer tablets is their capability for sequential drug release. This technology allows for the combination of two different active pharmaceutical ingredients (APIs) in a single dosage form, enabling a tailored therapeutic approach. Bi-layer tablets can be designed to provide an initial dose through the immediate-release layer, followed by a sustained-release layer that maintains drug concentration in the bloodstream for a more extended period. This sequential release is advantageous in treating chronic conditions, ensuring more consistent therapeutic outcomes.
3) Manufacturing Challenges
The production of bi-layer tablets involves unique challenges that manufacturers must address to guarantee quality and efficacy. Issues such as layer separation, cross-contamination, and difficulties with accurate weight control for each layer are significant obstacles. These complications often arise from the mechanical properties of the materials used, including their compression characteristics and strength. Consequently, the design of manufacturing processes and the selection of appropriate tablet presses become crucial to navigate these difficulties, including the ability to produce distinct layers without compromising the integrity of the final tablet.
4) Quality and GMP Requirements
Ensuring the quality of bi-layer tablets necessitates strict adherence to Good Manufacturing Practices (GMP) and specific quality control requirements. The choice of tablet press is vital, as it influences the hardness, visual separation, and consistent weight of the layers. It is imperative that the manufacturing equipment minimizes the risks of layer contamination, capping, and separation. Maintaining chemical and physical stability throughout production and storage is also essential, as it directly impacts the effectiveness of the drug delivery system.
5) Conclusion
In conclusion, bi-layer tablets offer a promising alternative to conventional dosage forms by enabling controlled release of multiple APIs within a single unit. While they present significant advantages, such as enhanced drug delivery and patient compliance, the challenges in manufacturing and quality control cannot be overlooked. A robust understanding of the formulation and production processes, along with effective quality risk management strategies, is necessary to fully realize the potential of bi-layer tablet technology in pharmaceutical applications. Further advancements in manufacturing techniques and regulatory frameworks will only enhance the therapeutic benefits of this innovative drug delivery method.
FAQ section (important questions/answers):
What are bi-layer tablets and their primary function?
Bi-layer tablets consist of two separately compacted layers, designed to sequentially release different drugs, separate incompatible substances, or provide both immediate and sustained release of medication.
What are the advantages of bi-layer tablets over traditional tablets?
Bi-layer tablets offer improved stability, controlled drug release profiles, and better patient compliance by reducing the frequency of dosing through fixed-dose combinations.
What challenges are associated with the formulation of bi-layer tablets?
Challenges include maintaining layer integrity, preventing cross-contamination, ensuring uniform weight distribution, achieving sufficient hardness, and tackling lamination issues during production.
How are bi-layer tablets manufactured effectively?
Effective manufacturing requires specialized tablet presses capable of providing distinct layer separation, weight monitoring, and sufficient hardness while preventing cross-contamination between the layers.
What are some common applications of bi-layer tablet technology?
Bi-layer tablets are used for combination therapy, delivering loading and maintenance doses, and creating specific release profiles tailored for various therapeutic needs.
What are the key quality requirements for bi-layer tablets?
Quality requirements include physical and chemical stability, predictable drug release, sufficient mechanical strength, and compliance with GMP standards during production.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Bilayer tablet-technology- a review”. 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, cure, treat, or prevent disease. It has various forms, such as tablets, capsules, or injections. In the context of bi-layer tablets, the drug is a vital component, with different release profiles from each layer, enabling tailored drug delivery for enhanced therapeutic efficacy.
2) Quality:
Quality in pharmaceuticals refers to the standard of a drug product including its purity, potency, and effectiveness. In bi-layer tablet development, ensuring quality is crucial for safety and efficacy. Adhering to Good Manufacturing Practices (GMP) ensures that the tablets meet required specifications and can perform as intended.
3) Substance:
A substance is a particular kind of matter with uniform properties. In pharmaceuticals, it often refers to active pharmaceutical ingredients (APIs) that are responsible for the therapeutic effects of a drug. The bilayer tablet can contain multiple substances with distinct release characteristics for optimized drug delivery.
4) Pur:
The term poor refers to inadequate quality or performance. In pharmaceuticals, poor drug solubility can lead to ineffective treatment outcomes. For bilayer tablets, formulations must avoid poor characteristics like uneven release rates or insufficient hardness, which can lead to problems such as capping or separation during production.
5) Powder:
Powder refers to finely grained solid substances, often used in the formulation of tablets. In bilayer tablets, different powders representing the drug and excipients are sequentially compressed to form layers. The properties of the powder affect the processing, compression, and ultimately, the drug release profile of the tablet.
6) Developing:
Developing pertains to the process of creating or formulating new products. In the pharmaceutical context, developing bilayer tablets involves extensive research on formulation techniques, material compatibility, and manufacturing processes. Successful development leads to novel delivery systems, improving drug efficacy and patient compliance across various treatment regimens.
7) Disease:
A disease is a pathological condition of a bodily part, an organism, or system resulting from various causes. Bi-layer tablets are particularly beneficial in treating diseases requiring multi-drug therapy. Their design allows for the controlled release of medications to manage chronic conditions like hypertension or diabetes effectively.
8) Bitter:
Bitter describes an unpleasant taste that may deter patients from taking certain medications. In developing bi-layer tablets, bitter drugs often require specific formulation strategies, such as coating, to mask their taste. Ensuring patient compliance involves overcoming such challenges to enhance the overall therapeutic experience.
9) Nature:
Nature refers to the inherent characteristics or properties of a substance. In pharmaceuticals, understanding the nature of the active ingredients is essential for formulating effective bi-layer tablets. Factors like solubility, stability, and interaction with excipients can dictate the success of drug delivery and patient outcomes.
10) India:
India is a significant player in the global pharmaceutical industry, known for its vast variety of drugs and formulations. The research and development of innovative drug delivery systems, including bi-layer tablets, take place in India, contributing to advancements in toxicity management, patient compliance, and therapeutic efficacy.
11) Road:
Road generally refers to a pathway or course, which, in metaphorical terms, could represent the journey of drug formulation development. In the production of bi-layer tablets, the 'road' signifies the challenges and milestones reached from initial research to successful market-ready products, ensuring quality and compliance throughout.
12) Life:
Life denotes the condition of being alive, particularly regarding human health. In relation to pharmaceuticals, life underscores the importance of effective drug delivery systems like bi-layer tablets in managing diseases and improving health outcomes. The goal is to maximize therapeutic benefits while minimizing side effects for patients.
13) Unconscious:
Unconscious refers to a state where an individual is not aware of their surroundings or cannot respond. This can complicate drug administration methods. Bi-layer tablets, designed for easy swallowing and potential coatings, aim to optimize drug delivery even for patients who cannot actively participate in their medication management.
14) Swallowing:
Swallowing is the act of ingesting an item through the mouth into the digestive system. In pharmacology, the ease of swallowing pills is crucial for patient compliance. Bi-layer tablets can be designed to be more palatable or easier to swallow, ensuring that patients adhere to their prescribed regimens without issue.
15) Science (Scientific):
Scientific relates to the systematic study of phenomena through observation and experimentation. In pharmaceutical development, a scientific approach is essential for understanding drug interactions, release mechanisms, and formulation stability. The development of bi-layer tablets relies heavily on scientific principles to enhance drug delivery and efficacy.
16) Stiffness:
Stiffness refers to the rigidity of a material, indicating how much it resists deformation under stress. In the context of bi-layer tablets, appropriate stiffness of each layer is crucial to avoid interface problems like layer separation and capping, which can affect the tablet's structural integrity and performance.
17) Transformation (Transform, Transforming):
Transform means to change in form, appearance, or structure. In drug delivery, the transformation of the drug during the gastrointestinal (GI) process is significant for its release profile. Bi-layer tablets aim to transform the release characteristics of drugs, enabling a controlled and sustained delivery for improved therapeutic outcomes.
18) Toxicity:
Toxicity refers to the degree to which a substance can damage an organism. When designing bi-layer tablets, it’s essential to minimize toxicity related to drug interactions. Understanding the toxicity profiles of different active ingredients ensures that combined medications can be administered safely to patients without adverse effects.
19) Surface:
Surface pertains to the outer layer or boundary of an object. In pharmaceutical formulations, surface characteristics of tablets play a significant role in dissolution and drug release. The design of bi-layer tablets must account for surface properties to create effective barriers that regulate drug release rates while maintaining stability.
20) Saroja (Saras-ja):
Saroja likely refers to one of the authors involved in the research or development of the bi-layer tablet technology discussed in the article. The collaboration of researchers like Saroja illustrates the collective effort necessary to enhance drug delivery systems, ensuring innovation and adherence to quality in pharmaceutical development.
21) Reason:
Reason denotes a basis or cause for an action or event. In developing bi-layer tablets, researchers consider various reasons for their design, including addressing the need for separate release profiles for incompatible drugs, improving patient compliance, and enhancing therapeutic outcomes across diverse treatment regimens.
22) Field:
Field refers to a domain or area of study or activity. The field of pharmaceuticals encompasses a wide range of topics, including drug formulation and delivery systems. Advances in the field of bi-layer technology focus on improving existing processes and addressing limitations related to drug release profiles and patient adherence.
23) Blood:
Blood is a vital fluid in the body responsible for transporting nutrients, oxygen, and waste. In drug delivery, the concentration of drugs in blood plasma is crucial. Bi-layer tablets aim to regulate the release of drugs in such a way as to maintain optimal therapeutic levels in the bloodstream without causing toxicity.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Bilayer tablet-technology- a review’. Further sources in the context of Science might help you critically compare this page with similair documents:
Drug delivery system, Mechanical properties, Combination therapy, Dosage form, Sustained release, Pharmaceutical development, Tablet formulation, Novel drug delivery system, Weight control, Patient convenience, GMP requirements, Mechanical strength, Active pharmaceutical ingredient, Cross-contamination, Compression Force, Unit dosage form, Emerging trend.
Concepts being referred in other categories, contexts and sources.
Immediate release, Formulation and Evaluation.