Formulation and evaluation of mouth dissolving tablets of an antidiabetic drug
Journal name: World Journal of Pharmaceutical Research
Original article title: Formulation and evaluation of mouth dissolving tablets of an antidiabetic drug
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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Original source:
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Megha N. Karemore, R.C. Gulwade, D.R. Mundhada and S. Bhaskaran
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Formulation and evaluation of mouth dissolving tablets of an antidiabetic drug
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201612-7459
Download the PDF file of the original publication
Summary of article contents:
Introduction
Oral drug administration is recognized as one of the most convenient routes for delivering therapeutic agents, but it encounters significant limitations such as poor absorption and the first-pass metabolism of certain drugs. These issues lead to inadequate therapeutic levels for some patients. To address these challenges, researchers are developing intraoral drug delivery systems to enhance therapeutic drug levels, improve bioavailability, and provide easier dosing alternatives. One such advancement is the development of mouth dissolving tablets (MDTs), which dissolve quickly in the oral cavity, allowing for pregastric absorption and improved efficacy.
Development of Mouth Dissolving Tablets
The study focused on formulating mouth dissolving tablets of Voglibose, an alpha-glucosidase inhibitor used in managing type 2 diabetes, to enhance patient compliance. Various superdisintegrants, including sodium starch glycolate, cross carmellose sodium, and indion 414, were utilized to develop these tablets. The formulations were created through a direct compression method, where the drug and excipients were mixed without prior granulation, providing ease of manufacturing. The goal was to achieve a balance between rapid disintegration and high bioavailability of the drug.
Evaluation of Formulations
The evaluation of various formulations involved assessing parameters such as disintegration time, wetting time, water absorption ratio, and in-vitro drug release. Among the tested formulations, V9, which contained 10% indion 414, exhibited the fastest disintegration time of 27 seconds and a notable water absorption ratio of 88.22%. Additionally, it demonstrated excellent drug release characteristics, with a completion of 98.38% dissolution within three minutes. This formulation had comparable release profiles to the marketed product.
Importance of Superdisintegrants
The role of superdisintegrants was crucial in the formulation of MDTs. Sodium starch glycolate showed effective disintegration properties at lower concentrations, while cross carmellose sodium and indion 414 provided enhanced performance at higher concentrations. The choice of superdisintegrants significantly influenced the physicochemical characteristics of the tablets, demonstrating the importance of selecting appropriate excipients to optimize drug formulation for improved therapeutic outcomes.
Conclusion
The study successfully formulated and evaluated mouth dissolving tablets of Voglibose using different superdisintegrants, with formulation V9 identified as the optimal choice. It exhibited a rapid disintegration time, high water absorption capacity, and comparable drug release to marketed formulations. This research highlights the potential of MDTs in enhancing patient compliance in diabetes management through improved bioavailability and therapeutic effectiveness. The successful formulation and insights gained contribute to the ongoing development of innovative oral drug delivery systems.
FAQ section (important questions/answers):
What are mouth dissolving tablets and their benefits?
Mouth dissolving tablets (MDTs) are solid dosage forms that rapidly disintegrate in the oral cavity without the need for water. They enhance drug bioavailability by avoiding first-pass metabolism, improve patient compliance, and are easier to swallow compared to conventional tablets.
What is the main purpose of the study conducted?
The study aimed to formulate and evaluate mouth dissolving tablets of voglibose, an antidiabetic drug, to enhance patient compliance and improve the therapeutic effects while addressing the issues related to conventional dosage forms.
What methodology was used to prepare the mouth dissolving tablets?
Mouth dissolving tablets were prepared using the direct compression method, involving blending voglibose with excipients like superdisintegrants and then compressing the mixture into tablets using a rotary tablet machine.
What were the key findings regarding drug release and stability?
Formulation V9 containing 10% indion 414 demonstrated optimal disintegration and drug release, achieving 98.38% of the drug released in three minutes. The formulations remained stable over four weeks at elevated temperatures.
What excipients were used in the formulation of MDTs?
The formulation included various excipients such as sodium starch glycolate, croscarmellose sodium, indion 414, microcrystalline cellulose, aspartame, magnesium stearate, and talc to enhance drug release and stability.
How was the drug content assessed in the study?
Drug content was determined by crushing and dissolving the tablets in methanol, followed by derivation and measurement of UV absorbance at 282 nm to ascertain the concentration based on a standard graph.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Formulation and evaluation of mouth dissolving tablets of an antidiabetic drug”. 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:
In pharmaceutical contexts, a 'drug' refers to a substance used to diagnose, cure, treat, or prevent diseases. In the article, voglibose is highlighted as an antidiabetic drug specifically formulated into mouth dissolving tablets. Understanding drug properties and formulations is crucial for enhancing patient compliance and therapeutic efficacy.
2) Water:
'Water' serves as a universal solvent and is often used in drug formulations, particularly for dissolving or dispersing ingredients. In the case of mouth dissolving tablets, the water absorption ratio is a critical parameter influencing disintegration, which affects the drug's release and overall bioavailability in the body.
3) Study (Studying):
A 'study' refers to a systematic investigation or examination, typically aimed at adding to knowledge in a given field. The article presents a study on the formulation and evaluation of mouth dissolving tablets of voglibose, contributing valuable insights into their effectiveness and patient compliance in managing diabetes.
4) Agnihotrin (Agnihotri, Agnihotr, Agni-hotrin, Agni-hotri):
Agnihotri is the name of the college where the research was conducted (Agnihotri College of Pharmacy). The association with this institution indicates a framework for academic research, enabling the exploration of innovative drug delivery systems like mouth dissolving tablets to enhance pharmacological outcomes for patients.
5) Wardha:
'Wardha' is a location in Maharashtra, India, where the Agnihotri College of Pharmacy is situated. Its geographical context is essential as it highlights the institution's regional focus on pharmaceutical research, aiding local and national health initiatives, particularly in diabetes management through improved drug formulations.
6) Table:
In the context of pharmaceutical formulations, a 'tablet' is a solid dosage form that contains medicinal substances. The article discusses the formulation of mouth dissolving tablets, which offer advantages such as rapid disintegration and dissolution in the oral cavity, enhancing drug absorption and patient compliance in treatment regimens.
7) India:
'India' indicates the geographical and cultural context in which the research is conducted. The country has a diverse population with varying health conditions, including diabetes. This context makes the development of innovative drug delivery systems, such as mouth dissolving tablets, particularly relevant in addressing public health issues.
8) Maharashtra (Maharastra, Maha-rashtra):
'Maharashtra' is a state in India, hosting the Agnihotri College of Pharmacy. The state’s healthcare infrastructure and industry collaborations play a pivotal role in advancing pharmaceutical research and innovation, specifically in producing formulations aimed at enhancing oral drug delivery and patient adherence to prescribed therapy.
9) Megha:
Megha refers to one of the authors (Megha N. Karemore) of the research paper, highlighting her contributions to the field of pharmaceutical sciences. Her work focuses on drug formulation, showcasing the importance of academic research in developing effective pharmaceutical products for better patient outcomes in diabetes management.
10) Blood:
'Blood' is a crucial bodily fluid involved in transporting nutrients and oxygen. In the study, controlling post-prandial blood glucose levels is emphasized, presenting the need for effective antidiabetic therapies. Understanding how drug formulations affect blood parameters is vital for improving diabetes control in patients.
11) Discussion:
The term 'discussion' typically refers to the analysis and interpretation of study findings. In the context of the research article, the discussion would encompass the evaluation of formulation results, comparisons with existing products, and implications for future drug development, enhancing understanding of mouth dissolving tablet effectiveness.
12) Developing:
Developing pertains to the process of creating new formulations, indicating the active role of researchers in innovation. In the study, the focus is on developing mouth dissolving tablets of voglibose, addressing challenges of conventional oral dosage forms and enhancing patient compliance with easier drug administration.
13) Swallowing:
'Swallowing' is the physiological act of moving substances from the mouth to the stomach. Mouth dissolving tablets are designed to dissolve without the need for swallowing, making them suitable for patients who have difficulties with traditional tablets and enhancing the overall patient experience.
14) Substance:
A 'substance' refers to any material with distinct properties, including chemical compounds used in pharmaceuticals. In the formulation of mouth dissolving tablets, substances like voglibose and various excipients are critical in achieving desired bioavailability, stability, and patient acceptance in drug delivery.
15) Quality:
'Quality' indicates the standard of a product in terms of effectiveness and safety. In pharmaceutical formulation, ensuring the quality of mouth dissolving tablets is essential for reliable drug release patterns, ensuring that therapeutic outcomes align with patients' expectations and regulatory standards.
16) Medium:
'Medium' refers to the environment in which the dissolution or absorption occurs, such as the phosphate buffer used in in-vitro studies for testing the drug's release. The selection of an appropriate medium is critical to mimic physiological conditions and assess the performance of drug formulations accurately.
17) Powder:
'Powder' denotes the physical form of substances prior to tablet formulation. The study highlights the use of powders, including the active drug and excipients, which are blended and compressed to form tablets. The properties of the powder significantly influence the final tablet characteristics and performance.
18) Shri (Sri, Sr):
'Shri' is an honorific title used in India, often preceding names. In the article, it precedes Shri Shankarprasadji Agnihotri, acknowledging his role as an important figure in facilitating the research process at Agnihotri College of Pharmacy, contributing to academic and scientific advancements in pharmacy.
19) Pune:
'Pune' is a city in Maharashtra known for its educational and healthcare institutions. The article mentions that certain materials and excipients were procured from Pune, highlighting the collaboration and availability of resources within the region, contributing to effective pharmaceutical research and development efforts.
20) Wall:
'Wall' often alludes to biological barriers like the gut-wall that can affect drug absorption. The discussion of overcoming gut-wall metabolism through innovative delivery systems, such as mouth dissolving tablets, underscores how formulation strategies aim to enhance drug bioavailability through efficient delivery mechanisms.
21) Post:
In this context, 'post' refers to the period after a meal, highlighting the importance of controlling post-prandial blood glucose levels in diabetes management. The formulation of mouth dissolving tablets aims to aid patients in managing their blood glucose effectively during this critical time.
22) Pur:
'Poor' indicates unfavorable conditions, such as poor absorption rates that may hinder effective drug delivery in traditional formulations. The article discusses these limitations and reaffirms the need for innovative mouth dissolving tablets to address poor bioavailability issues commonly faced by diabetic patients.
23) Life:
'Life' reflects the broader impact of effective medication on quality of life. Improved formulations like mouth dissolving tablets aim to enhance patient compliance and therapeutic effectiveness, ultimately contributing to a better quality of health and life for individuals managing chronic conditions like diabetes.