Gastro-retentive floating drug delivery system for nitrendipine tablets

| Posted in: Scientific

Journal name: World Journal of Pharmaceutical Research
Original article title: Development of formulation and in-vitro evaluation of gastro retentive floating drug delivery system for nitrendipine bilayer tablets
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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Author:

P.Gopalakrishna, B.Ramarao, G. Chiranjeevi, Ramyasri.S


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Development of formulation and in-vitro evaluation of gastro retentive floating drug delivery system for nitrendipine bilayer tablets

Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research


Download the PDF file of the original publication


Summary of article contents:

Introduction

The study by Gopalakrishna et al. focuses on the formulation and in-vitro evaluation of gastro-retentive floating bilayer tablets for the drug Nitrendipine, a calcium channel blocker primarily used for the treatment of hypertension. The work aims to enhance the drug's bioavailability through a novel drug delivery system that ensures the sustained release of the drug over an extended period, thereby improving therapeutic efficacy while minimizing side effects. The research encapsulated several methodologies, including drug-excipient compatibility studies, pre-compression evaluations, and dissolution tests, to optimize the formulation.

Evaluation of Drug-Excipient Compatibility

One crucial aspect of the study was the drug-excipient compatibility assessment conducted using Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC). The FTIR analysis revealed that the spectral peaks corresponding to the functional groups of Nitrendipine remained unchanged, indicating no significant interactions between the drug and the excipients used. DSC thermograms further supported this finding by showing that there was no incompatibility among the substances, thus confirming that the formulation components could work together effectively without risking undesirable reactions.

Pre-compression and Quality Control Attributes

The research highlighted the importance of evaluating pre-formulation parameters such as angle of repose, bulk density, and tapped density, among others. These parameters indicated that the powder blends used in both immediate and sustained release layers possessed desirable flow properties. Additionally, quality control tests for the compressed tablets, including weight variation, hardness, friability, thickness, and drug content, demonstrated that all formulations met the necessary specifications and standards, ensuring the reliability of the drug dosage form in actual applications.

Dissolution and Release Kinetics of Nitrendipine

Significantly, the dissolution tests illuminated the drug release profile of the Nitrendipine floating bilayer tablets. Formulation FT5, which utilized Locust bean gum, exhibited optimal release characteristics, with a drug release of 97.12% over 12 hours. Kinetics analysis indicated that the substance followed Kars mayer-peppas kinetics, demonstrating a sustained release mechanism. These results suggest that the formulation can maintain therapeutic levels of the drug effectively, thereby maximizing its antihypertensive effects while minimizing peak plasma concentrations that could lead to side effects.

Conclusion

In conclusion, the research effectively demonstrates the potential of gastro-retentive floating bilayer tablets for the controlled delivery of Nitrendipine. The comprehensive evaluation of formulation parameters, drug-excipient compatibility, quality control tests, and detailed dissolution studies indicate that such systems can enhance the bioavailability and therapeutic effectiveness of poorly soluble drugs. Overall, the optimized formulation shows promise as an innovative approach to improve patient outcomes in managing hypertension through sustained drug delivery. This advancement highlights the importance of developing specialized delivery systems for therapeutic agents, ultimately leading to improved clinical effectiveness.

FAQ section (important questions/answers):

What is the main aim of this study on Nitrendipine?

The main aim of the study is to formulate and evaluate gastro retentive floating bilayer tablets of Nitrendipine using an effervescent method for better drug delivery.

What are the layers of the formulated Nitrendipine tablets?

The tablets consist of an immediate release (IR) layer and a sustained release (SR) layer, which were compressed using a direct compression method.

What was the optimal formulation for the immediate release layer?

The IR2 formulation was concluded as optimized after showing maximum drug release of 95.62% within 15 minutes in the dissolution study.

Which formulation exhibited the best drug release for the floating bilayer tablets?

The FT5 formulation, which contains Locust bean gum, demonstrated the best drug release of 97.12% over 12 hours with a low floating lag time.

How was drug compatibility assessed in this study?

Drug-excipient compatibility was evaluated using Fourier Transform-Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC), confirming no interactions between Nitrendipine and other ingredients.

What type of polymers were used in the Nitrendipine formulations?

The study utilized natural polymers like Locust bean gum and Gum karaya, semi-synthetic polymers like Sodium Alginate and Chitosan, and synthetic polymers like HPMC for the formulations.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Gastro-retentive floating drug delivery system for nitrendipine tablets”. 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 in the diagnosis, treatment, or prevention of disease. In this study, the focus is on Nitrendipine, a calcium channel blocker effective in managing hypertension. The drug's pharmaceutical formulation is critical for optimal release and efficacy in treatment, emphasizing its importance in the realm of pharmaceutical science.

2) Powder:
The powdered form of substances is crucial in pharmaceutical formulations, including the gastro-retentive floating bilayer tablets being developed in this study. The properties of the powder, such as flowability and compressibility, affect the overall quality of the tablets produced, making powder characteristics a key focus in this scientific investigation.

3) Table:
In the context of this research, 'table' refers to the bilayer tablets of Nitrendipine being developed. These tablets represent a significant advancement in drug delivery systems by providing both immediate and sustained release capabilities, showcasing the importance of dosage forms in improving patient compliance and therapeutic outcomes.

4) Patel:
[see source text or glossary: #Patel#]

5) Channel:
The term 'channel' refers to calcium channels, which are integral in the mechanism of action of Nitrendipine, as it inhibits calcium influx across cell membranes. Understanding the role of channels in drug action is fundamental in pharmacology and therapeutic science to achieve therapeutic effects in cardiovascular conditions.

6) Quality:
Quality refers to the attributes of the pharmaceutical tablets being developed, including uniformity, hardness, and drug release profile. Quality control tests are essential throughout the research study to ensure that the formulations meet specified standards, thereby ensuring their efficacy and safety for therapeutic use.

7) Study (Studying):
The study explores the formulation and evaluation of gastro-retentive floating drug delivery systems, highlighting the scientific methods used to optimize drug release and increase gastric retention time. Such studies are pivotal in pharmaceutical research to enhance drug delivery efficiency and patient adherence.

8) Science (Scientific):
Scientific inquiry is the foundation of this research, utilizing rigorous experimental methodologies to analyze drug formulations and their effects. Valid scientific processes ensure that the findings are reliable and can contribute to the field of pharmaceutical science.

9) Blood:
Blood pressure regulation is a key therapeutic goal of Nitrendipine, which acts on the cardiovascular system. Understanding drug effects on blood pressure is crucial in treating hypertension and requires a solid foundation in pharmacokinetics.

10) Kumar:
[see source text or glossary: #Kumar#]

11) Pain:
While the primary use of Nitrendipine is in managing hypertension, any potential side effects like cardiovascular pain or discomfort should be monitored. Understanding drug effects on pain receptors is an essential aspect of pharmacological studies.

12) Life:
Pharmaceutical research ultimately aims to enhance life quality by developing effective medications. The study's outcomes have the potential to improve the management of hypertension, positively influencing patients' life quality and longevity.

13) Observation:
Observation plays a vital role in the research methodology of this study, enabling the researchers to assess the physical and chemical properties of the formulated tablets and their performance in dissolution studies, forming a basis for scientific conclusions.

14) Discussion:
The discussion section of the study presents a detailed analysis of the findings, comparing them to existing literature to provide a comprehensive understanding of the floating drug delivery system's efficacy and its implications for future research and clinical practice.

15) Developing:
Developing novel formulations, like the gastro-retentive floating tablets, is central to the research. This ongoing process examines different excipients and drug interactions to enhance drug delivery systems and patient outcomes.

16) Drowsiness:
Drowsiness is a possible side effect of some antihypertensive medications. As part of patient care, understanding the side effects of drugs like Nitrendipine is essential in ensuring patient safety and adherence to treatment.

17) Transformation (Transform, Transforming):
The aim of the study is to transform traditional drug delivery methods by developing gastro-retentive systems. This transformative approach can lead to significant advancements in how medications are administered and absorbed in the body.

18) Mahale:
[see source text or glossary: #Mahale#]

19) Nausea:
Nausea may be a side effect associated with the administration of certain antihypertensive drugs. Researching this aspect allows for a better understanding of patient tolerability and adherence to treatment protocols.

20) Mathura (Mathur):
[see source text or glossary: #Mathur#]

21) Pandya (Pamdya, Pandyan):
[see source text or glossary: #Pandya#]

22) Gupta:
[see source text or glossary: #Gupta#]

23) Water:
Water solubility is a critical factor in determining the bioavailability of Nitrendipine. Understanding how the drug interacts with water—particularly in the formulation of tablets—directly impacts its effectiveness and the overall quality of the drug delivery system.

24) House:
[see source text or glossary: #House#]

25) Sura (Shura):
[see source text or glossary: #Sura#]

26) Post:
Post formulation evaluation is key in determining the efficacy of the developed tablets. Understanding the post-release characteristics helps in assessing their performance in real-world applications, solidifying the study's contributions to pharmaceutical sciences.

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