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Design, characterization, and evaluation of novel mucoadhesive nasal inserts for the treatment of hypertension

  • Shashank Agni

    Shashank Agni obtained his M. Pharm in Pharmaceutics from NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University) Mangalore, India. His area of research work is novel drug delivery systems.

    , Jobin Jose

    Dr. Jobin Jose obtained his PhD in Pharmaceutical Sciences from NITTE (Deemed to be University), Mangalore, in 2016. He has published two patents, more than ten book chapters and around 63 articles in peer-reviewed journals with high impact factor. His work includes microneedles and novel drug delivery systems. Presently, he is working as an Associate Professor in the Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, Mangalore, India.

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    , Sanjay R. Ugare

    Sanjay R. Ugare has been working as a Senior Assistant professor at KLE College of Pharmacy, Belagavi, India, for the past seven-years. His skill includes handling basic pharmacological screening animal models and analytical instruments and proficient at interpreting data from UV-Vis, Autoanalyzer and Microplate reader.

    , Lalit Kumar

    Dr. Lalit Kumar obtained his PhD in Pharmaceutical Sciences from Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India in 2016. He has filed two patents, published more than 20 book chapters and around 70 articles in peer reviewed journals. His work includes novel drug delivery systems (especially nanoformulations), analytical methods development, and QbD. Presently, he is an Assistant Professor in the Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur.

    and Kartik Bhairu Khot

    Kartik Bhairu Khota obtained his M. Pharm in Pharmaceutics from Rajiv Ghandi University of Health Sciences, India. He has published more than seven articles in peer reviewed journals. His work includes novel drug delivery systems and analytical methods development.

Published/Copyright: October 23, 2023
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Abstract

Nasal inserts are novel solid, bio-adhesive dosage forms that various methods can prepare. Nasal inserts work on the principle of nasal fluid absorption from the nasal mucosa on administration into the nasal cavity, where it forms gel, avoiding foreign body sensation. They are administered via the nasal route and help to accomplish delayed systemic drug delivery. This investigation aimed to develop lyophilized nasal inserts of diltiazem hydrochloride for the treatment of hypertension using various concentrations of xanthan gum and guar gum. The drug content, surface pH, hydrophilicity studies, water uptake studies, mucoadhesive studies, in vitro drug release studies, and ex vivo permeation studies of the drug-loaded inserts were carried out. It was further characterized and evaluated by differential scanning calorimetry, scanning electron microscopy, X-ray diffraction studies, histological investigation and stability studies. Lyophilized nasal inserts have advantages over other formulations due to their high-water uptake and mucoadhesion properties. The optimized formulation showed no significant changes in the treated nasal mucosa of the goat, and the stability of the formulation was confirmed by stability studies. The nasal insert containing xanthan gum and guar gum (1:3) is the optimized one because of its high drug content and better drug release when compared to other formulations. In conclusion, the novel nasal inserts of diltiazem hydrochloride could be a better alternative for treating hypertension.


Corresponding author: Jobin Jose, Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangalore, Karnataka 575018, India, E-mail:

About the authors

Shashank Agni

Shashank Agni obtained his M. Pharm in Pharmaceutics from NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University) Mangalore, India. His area of research work is novel drug delivery systems.

Jobin Jose

Dr. Jobin Jose obtained his PhD in Pharmaceutical Sciences from NITTE (Deemed to be University), Mangalore, in 2016. He has published two patents, more than ten book chapters and around 63 articles in peer-reviewed journals with high impact factor. His work includes microneedles and novel drug delivery systems. Presently, he is working as an Associate Professor in the Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, Mangalore, India.

Sanjay R. Ugare

Sanjay R. Ugare has been working as a Senior Assistant professor at KLE College of Pharmacy, Belagavi, India, for the past seven-years. His skill includes handling basic pharmacological screening animal models and analytical instruments and proficient at interpreting data from UV-Vis, Autoanalyzer and Microplate reader.

Lalit Kumar

Dr. Lalit Kumar obtained his PhD in Pharmaceutical Sciences from Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India in 2016. He has filed two patents, published more than 20 book chapters and around 70 articles in peer reviewed journals. His work includes novel drug delivery systems (especially nanoformulations), analytical methods development, and QbD. Presently, he is an Assistant Professor in the Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur.

Kartik Bhairu Khot

Kartik Bhairu Khota obtained his M. Pharm in Pharmaceutics from Rajiv Ghandi University of Health Sciences, India. He has published more than seven articles in peer reviewed journals. His work includes novel drug delivery systems and analytical methods development.

Acknowledgments

The authors are particularly thankful to NITTE, Deemed to be University, Mangalore, for providing the facilities to carry out the study.

  1. Research ethics: Not applicable.

  2. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  3. Competing interests: The authors state no conflicts of interest.

  4. Research funding: None declared.

  5. Data availability: Not applicable.

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Received: 2023-06-19
Accepted: 2023-07-10
Published Online: 2023-10-23
Published in Print: 2023-11-27

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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