Concurrent Validation and Statistical Analysis of Novel Bi-Layer Floating Tablet of Sucralfate and Metoprolol Succinate

Authors

Dr. Sreedhar Ranjan Das

Professor, Sontoshi institute of Pharmaceutical sciences, Manguli, Cuttack., Odisha, India (India)

Dr Santosh Kumar Bala

Professor and Principal, Sontoshi institute of Pharmaceutical sciences, Cuttack., Odisha (India)

Dr kalakar Bala

Associate Proffessor , Pharmacy wing, SCB Medical college, Cuttack (India)

Somya Ranjan Sahoo

Associate Professor, Sontoshi institute of Pharmaceutical sciences, Cuttack., Odisha (India)

Article Information

DOI: 10.51244/IJRSI.2026.1306000023

Subject Category: Pharmaceutics

Volume/Issue: 13/6 | Page No: 400-405

Publication Timeline

Submitted: 2026-05-22

Accepted: 2026-05-27

Published: 2026-06-18

Abstract

The research work is based on validation and statistical analysis of Bilayer Floating Tablet containing bilayer floating tablet of Sucralfate and Metoprolol Succinate. First the initially formulated and evaluated Bi layer floating tablet of Sucralfate and Metoprolol succinate (DSFMS). We performed the stability study as per the ICH guideline. Then evaluation of the tablets according to Concurrent validation process. Then final resultant value compared with the initial resultant values and checked the equivalency with the acceptance criteria of Bilayer Floating Tablet. Then statistical analysis were done by calculating mean deviation and standard aviation. Then compared statistical parameters a over limit or under limit.
After stability study and Concurrent validation of (DSFMS) it is confirmed that the formulation fulfill all the acceptance criteria of Bilayer floating tablet. It is confirmed that the formulation (DSFMS) satisfying all acceptance criteria of Bilayer floating tablet. The statistical parameters are under limit.

Keywords

Ulcer protective, Sucralfate, Antihypertensive, Metoprolol Succinate, Bilayer floating tablet

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References

1. Kaushik.H, Stomach Ulcer During Pregnancy - Causes, Symptoms, Diagnosis & Treatment Publication available at: https://www.momjunction.com/articles/peptic-ulcerduring- pregnancy_00372291/[ Accessed March 27, 2019] [Google Scholar] [Crossref]

2. Berg CJ, Henderson Z, Callaghan WM, Severson C. Mortality related in Pregnancy in the UnitedStates. Obstetric Gynecology, 2010 ;116(6):1302–1309. doi: 10.1097/AOG.0b013e3181fdfb11 [Google Scholar] [Crossref]

3. Ayala DE, Hermida RC. Monitoring of Early Identification of Hypertension in Pregnancy. Chronobiol Int. 2012; Sep 24. DOI: 10.3109/07420528.2012.714687. [Google Scholar] [Crossref]

4. Tripathy KD, Essential of Medical Pharmacology. Fifth edition, New Delhi, India: Jaypee brothers’ medical publishers ltd; Page-596. [Google Scholar] [Crossref]

5. Metoprolol Succinate, Medically reviewed by Drugs.com. Avilable at: https:// www.drugs.com. [Accessed February 25, 2019] [Google Scholar] [Crossref]

6. Drug-Drug Interactions. Medically reviewed by Edward Flynn New Jersey Medical School, Newark, US. AvailableEhttps://www.sciencedirect.com/sdfe/pdf/download/eid/3-s2.0- B9780080552323600376/first-page-pdf. [ Accessed April, 2007] [Google Scholar] [Crossref]

7. Das SR, Panigrahi BB, Pani M. Development of Bi layered floating tablet of Sucralfate and Metoprolol succinate. Int. J. Adv. Res 2019; 7(5), 832-849, DOI:10.21474/IJAR01/9105. [Google Scholar] [Crossref]

8. Arora S, Ali J, Ahuja A, Khar R.K, Mabota S. Floating Drug Delivery System; A review. AAPS Pharma Science tech .2005;3: E 372-89. DOI:10.21474/IJAR01/9105. [Google Scholar] [Crossref]

9. Das SR, Panigrahi BB, Pani M. Development of s of Bi- layered Floating tablet of Sucralfate and Metoprolol succinate. Int. J. Adv. Res.2019; 7(5), 890-896 DOI: 10.21474/IJAR01/9111 [Google Scholar] [Crossref]

10. Four Types of Validation Used in The Life Sciences https://learnaboutgmp.com/good-validation-practices/the-four-types-of-validation-used-in-the-life-sciences/ [Google Scholar] [Crossref]

11. Statistical analysis: https://whatis.techtarget.com/definition/statistical-analysis September 2020 [Google Scholar] [Crossref]

12. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (ms), Availablehttp://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/.[ Accessed January 2017] [Google Scholar] [Crossref]

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