The role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin: Effect on drugs dissolution and gastric mucosa

According to the American College of Cardiology/American Heart Association (ACC/AHA), both aspirin and statin are used in the primary prevention of cardiovascular diseases. Aspirin (ASA) is contraindicated if there is gastrointestinal bleeding because it will exaggerate the condition. In this study,...

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Main Authors: Doaa H. Alshora, Mohamed A. Ibrahim, Gamal Zayed, Mohammed A. Al Rwashed, Heba A. Abou-Taleb, Marwa F. Ali
Format: Article
Language:English
Published: Elsevier 2022-05-01
Series:Saudi Pharmaceutical Journal
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1319016422000470
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author Doaa H. Alshora
Mohamed A. Ibrahim
Gamal Zayed
Mohammed A. Al Rwashed
Heba A. Abou-Taleb
Marwa F. Ali
author_facet Doaa H. Alshora
Mohamed A. Ibrahim
Gamal Zayed
Mohammed A. Al Rwashed
Heba A. Abou-Taleb
Marwa F. Ali
author_sort Doaa H. Alshora
collection DOAJ
description According to the American College of Cardiology/American Heart Association (ACC/AHA), both aspirin and statin are used in the primary prevention of cardiovascular diseases. Aspirin (ASA) is contraindicated if there is gastrointestinal bleeding because it will exaggerate the condition. In this study, the effect of surfactant; sodium lauryl sulfate (SLS), in enhancing the in vitro dissolution of simvastatin (SIM) and ASA, as well as gastric irritation and upset, was studied. Oral tablets containing both ASA and SIM with and without the SLS were manufactured using the direct compression technique. The prepared tablets were characterized with respect to hardness, friability, uniformity of dosage units, in vitro disintegration, and dissolution. The effect of the addition of SLS in reducing the in vivo irritation and protection of gastric mucosa were also investigated. The results showed that the compressed tablets possessed sufficient hardness, acceptable friability, and are uniform with respect to disintegration, drugs contents, and tablet weight. The results showed that SIM alone exhibited a gastroprotective effect on the induced irritation. In addition, the incorporation of the SLS in the tablets containing SIM and ASA significantly enhanced the dissolution rates of both drugs and significantly decreased the gastric irritation and the ulcer index. The ulcer index of aspirin was decreased from 2.3 for tablets manufactured without SLS to 0.8 for tablets containing SLS. In a conclusion, the addition of pH modifier surfactant; SLS could enhance the dissolution rate of poorly soluble acidic drugs, reduce gastric upset and irritation without any effect on the main characters of the tablets. Moreover, the addition of SLS is very useful in improving the therapeutic activities and reducing the side effects of ASA and SIM for patients who require long-term administration of these drugs.
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spelling doaj.art-ddeb7973697842aaa400b9737c2647f82022-12-22T02:36:19ZengElsevierSaudi Pharmaceutical Journal1319-01642022-05-01305635645The role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin: Effect on drugs dissolution and gastric mucosaDoaa H. Alshora0Mohamed A. Ibrahim1Gamal Zayed2Mohammed A. Al Rwashed3Heba A. Abou-Taleb4Marwa F. Ali5Department of Pharmaceutics, College of Pharmacy, King Saud University, Saudi Arabia; Corresponding author.Department of Pharmaceutics, College of Pharmacy, King Saud University, Saudi Arabia; Department of Pharmaceutics and Industrial Pharmacy, Al-Azhar University, Assiut, EgyptDepartment of Pharmaceutics and Industrial Pharmacy, Al-Azhar University, Assiut, Egypt; Al-Azhar Centre of Nanosciences and Applications (ACNA), Al-Azhar University, Assiut, EgyptDepartment of Pharmaceutics, College of Pharmacy, King Saud University, Saudi ArabiaDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Merit University (MUE), Sohag, EgyptDepartment of Pathology and Clinical Pathology, Faculty of Veterinary Medicine, Assuit University, EgyptAccording to the American College of Cardiology/American Heart Association (ACC/AHA), both aspirin and statin are used in the primary prevention of cardiovascular diseases. Aspirin (ASA) is contraindicated if there is gastrointestinal bleeding because it will exaggerate the condition. In this study, the effect of surfactant; sodium lauryl sulfate (SLS), in enhancing the in vitro dissolution of simvastatin (SIM) and ASA, as well as gastric irritation and upset, was studied. Oral tablets containing both ASA and SIM with and without the SLS were manufactured using the direct compression technique. The prepared tablets were characterized with respect to hardness, friability, uniformity of dosage units, in vitro disintegration, and dissolution. The effect of the addition of SLS in reducing the in vivo irritation and protection of gastric mucosa were also investigated. The results showed that the compressed tablets possessed sufficient hardness, acceptable friability, and are uniform with respect to disintegration, drugs contents, and tablet weight. The results showed that SIM alone exhibited a gastroprotective effect on the induced irritation. In addition, the incorporation of the SLS in the tablets containing SIM and ASA significantly enhanced the dissolution rates of both drugs and significantly decreased the gastric irritation and the ulcer index. The ulcer index of aspirin was decreased from 2.3 for tablets manufactured without SLS to 0.8 for tablets containing SLS. In a conclusion, the addition of pH modifier surfactant; SLS could enhance the dissolution rate of poorly soluble acidic drugs, reduce gastric upset and irritation without any effect on the main characters of the tablets. Moreover, the addition of SLS is very useful in improving the therapeutic activities and reducing the side effects of ASA and SIM for patients who require long-term administration of these drugs.http://www.sciencedirect.com/science/article/pii/S1319016422000470SimvastatinAspirinSLSTabletsIn vitro dissolutionCytokines
spellingShingle Doaa H. Alshora
Mohamed A. Ibrahim
Gamal Zayed
Mohammed A. Al Rwashed
Heba A. Abou-Taleb
Marwa F. Ali
The role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin: Effect on drugs dissolution and gastric mucosa
Saudi Pharmaceutical Journal
Simvastatin
Aspirin
SLS
Tablets
In vitro dissolution
Cytokines
title The role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin: Effect on drugs dissolution and gastric mucosa
title_full The role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin: Effect on drugs dissolution and gastric mucosa
title_fullStr The role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin: Effect on drugs dissolution and gastric mucosa
title_full_unstemmed The role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin: Effect on drugs dissolution and gastric mucosa
title_short The role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin: Effect on drugs dissolution and gastric mucosa
title_sort role of sodium lauryl sulfate on formulation of directly compressed tablets containing simvastatin and aspirin effect on drugs dissolution and gastric mucosa
topic Simvastatin
Aspirin
SLS
Tablets
In vitro dissolution
Cytokines
url http://www.sciencedirect.com/science/article/pii/S1319016422000470
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