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  • Design and Optimization of Floating Pulsatile Drug Delivery System in Nocturnal Acid Secretion

  • Photo Aditi Barhate* Photo Prathamesh Sargar

  • Department of Pharmacology, Matoshri College of Pharmacy, Eklahare, Nashik-422105

Abstract

Gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD) are major global health concerns in which nocturnal acid secretion plays a critical role in symptom recurrence and mucosal damage. Conventional therapies such as proton pump inhibitors (PPIs) and H₂ receptor antagonists (H₂RAs) often fail to provide adequate night-time acid suppression due to their inability to align with circadian rhythms of gastric acid secretion. This limitation has led to the development of chronotherapeutic drug delivery systems designed to synchronize drug release with biological rhythms. Floating pulsatile drug delivery systems (FPDDS) combine prolonged gastric retention with time-dependent drug release, ensuring drug availability during peak nocturnal acid secretion. These systems utilize hydrophilic and hydrophobic polymers to control lag time and release kinetics, while buoyancy is achieved through effervescent or swellable mechanisms. Optimization using Design of Experiments (DoE) enhances formulation efficiency, and evaluation through in vitro and in vivo studies confirms their effectiveness. Clinically, FPDDS offer improved nocturnal acid suppression, enhanced mucosal healing, reduced dosing frequency, and better patient compliance. Thus, FPDDS represent a promising chronotherapeutic approach for managing nocturnal acid-related disorders.

Keywords

GERD, PUD, Chronotherapy, Floating systems, Pulsatile release, Nocturnal acid

Introduction

Gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD) are among the most prevalent acid-related gastrointestinal disorders worldwide, significantly affecting patient quality of life and imposing a considerable burden on healthcare systems [1]. These conditions arise primarily due to an imbalance between aggressive factors such as gastric acid, pepsin, and bile salts, and defensive mechanisms including mucosal barrier integrity, bicarbonate secretion, and prostaglandin-mediated protection [2]. Despite advancements in pharmacotherapy, including the widespread use of proton pump inhibitors (PPIs) and H₂ receptor antagonists (H₂RAs), the effective management of these disorders remains challenging, particularly due to the persistence of nocturnal symptoms [3]. A critical yet often under-recognized contributor to the pathophysiology of GERD and PUD is nocturnal acid secretion, which refers to the sustained production of gastric acid during the night when physiological defense mechanisms are diminished [4]. During sleep, several protective processes are significantly reduced, including salivary secretion, swallowing frequency and esophageal peristalsis. These changes lead to prolonged exposure of the esophageal and gastric mucosa to acidic contents, thereby increasing the risk of mucosal damage and symptom exacerbation [5]. In patients with GERD, the supine position during sleep further facilitates the backflow of gastric contents into the esophagus, resulting in prolonged acid exposure, epithelial injury, and sleep disturbances [6]. Similarly, in PUD, particularly duodenal ulcers, increased nocturnal acid secretion prolongs mucosal exposure to aggressive factors, delaying healing and contributing to disease recurrence [7].

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Aditi Barhate
Corresponding author

Department of Pharmacology, Matoshri College of Pharmacy, Eklahare, Nashik-422105

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Prathamesh Sargar
Co-author

Department of Pharmacology, Matoshri College of Pharmacy, Eklahare, Nashik-422105

Aditi Barhate*, Prathamesh Sargar, Design and Optimization of Floating Pulsatile Drug Delivery System in Nocturnal Acid Secretion, Int. J. Sci. R. Tech., 2026, 3 (4), 183-199. https://doi.org/10.5281/zenodo.19414865

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