Effect of Combination of Natural and Synthetic Film-Forming Polymers on The Dissolution Rate of Lansoprazole from Its Immediate Release Oral Thin Films

Lansoprazole is a proton-pump inhibitor and was used in the treatment of gastric acid disorders. Lansoprazole oral thin films are fast dissolving films and are a new, patient-friendly, and more convenient formulation of lansoprazole, which can be taken with or without water. It disintegrates rapidly in the mouth and is swallowed easily with the patient’s saliva. This is an improved alternative formulation for all patients and offers the benefit of a choice of administration of lansoprazole. This article deals with the formulation and evaluation of Lansoprazole oral thin films (OTFs). The main objective of this study was to study the effect of the combination of synthetic polymers [Polyvinyl alcohol (PVA) and/or polyvinyl pyrrolidone (PVP)]and natural polymers (gelatin or maltodextrin) on the film-forming properties and dissolution rate of the drug. The films were prepared by solvent casting method, using a natural and synthetic film-forming polymer in different concentrations, PEG 400 is used as a plasticizer, aspartame, and vanilla flavor as an artificial sweetener and artificial flavor respectively. The prepared films were evaluated for weight uniformity, film thickness, folding endurance, dispersion test, drug content, and in vitro dissolution studies to ensure the physical stability of films. The formulation F11with (PVP: PVA: Gelatin in the ratio of 2:1:1 respectively) has physicochemical, mechanical properties. F11 films exhibit lower values a t50, t90 of less than 2 min and 10 min respectively, and highest dissolution efficiency at 10 min (DE10) of 66.40. It follows a first-order drug release profile with a regression coefficient (r2) of 0.995 and a first-order rate constant (K1) of 0.216 min-1.F11 is considered as an optimized formulation with desired properties. Hence the combination of synthetic polymers (PVA and PVP)and natural polymer (gelatin) in the ratio of (PVP:PVA: Gelatin::2:1:1) had a significant effect on the film-forming properties and dissolution rate of the drug. Fast dissolving lansoprazole oral thin films are suitable for effective and well-tolerated treatment options in the management of gastric acid-related disorders. P.V. Swamy1, P. Sailaja2, Ashok Thulluru3, M. Raj Kumar1* 1Dept. of Pharmaceutics, Shri Vishnu College of Pharmacy (Autonomous), Vishnupur, Bhimavaram-534 202, West Godavari Dist. , Andhra Pradesh, India. 2Dept. of Pharmaceutics, AU College of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530 003, Vishaka Dist. , Andhra Pradesh, India. 3Dept. of Pharmaceutical Quality Assurance, Shri Vishnu College of Pharmacy (Autonomous), Vishnupur, Bhimavaram-534 202, West Godavari Dist. , Andhra Pradesh, India. Submitted: 24 October 2021 Accepted: 30 October 2021 Published: 30 November 2021 www.ijppr. humanjournals.com Citation: M. Raj Kumar et al. Ijppr.Human, 2021; Vol. 22 (4): 273-290. 274 INTRODUCTION: Lansoprazole (LZ) is a proton-pump inhibitor (PPI) and was used in the treatment of gastric acid disorders (gastric ulcers, duodenal ulcers, gastroesophageal reflux (GER) and gastroduodenal lesions induced by over usage of NSAIDs.It’smechanism of action is on in gastric parietal cells, by inactivating the final step of gastric acid secretion pathway in a dosedependent manner. LZ is also effective in the eradication of H. pylori through different regimens and it is a first-line PPI used for this purpose.Lansoprazole oral thin films (LZOTFs) are orally dissolving films and are a new, patient-friendly, and more convenient formulation of lansoprazole, which can be taken with or without water. It disintegrates rapidly in the mouth and is swallowed easily with the patient’s saliva. This is an improved alternative formulation for all patients requiring LZ, offering the benefits of a choice of administration. LZOTFs maintain the same pharmacological properties as LZ capsules and can be taken by any patient who is currently prescribed LZ. The ability to take a tablet either with or without water will offer increased convenience and flexibility, particularly when patients are traveling, and may help to improve compliance in some patients. In addition, LZOTFs may be suitable for certain groups of patients, such as those with dysphasia associated with gastroesophageal reflux disease,dynophagia or strictures, and the elderly or long-term care patients. This article summarizes the formulation and evaluation of LZOTFs. The main objective of this study was to select the best combination of polymer and excipients to formulate LZOTFs.