The aim of this research is to compare the physicochemical and release properties of amoxicillin trihydrate tablets 500mg using different binder (Peptin powder B.P, Microcrystalline cellulose and Corn starch mucilage at different concentration of 5%, 7.5%, 10% and 12.5%) to evaluate the hardness, thickness, tensile strength, weight uniformity, friability, disintegration time, dissolution rate/absorbance, moisture content and FTIR . It was revealed from the result of the study that the angle of repose varied from 30.2 ±2.96 to 27.2 ±1.2. This shows that the granules had good flow property as they were below 30o which indicates the granules is free flowing. The bulk density was found to be in the range of 0.56 ±0.05 to 0.54 ±0.056. As the granule size increases, bulk density decreases. The tapped density range from 0.65 ±0.06 to 0.65 ±0.06 while compressibility index was between 17.41 ±12.6 to 8.92 ±3.61. This was less than 10% indicated in the British Pharmacopeia from excellent flow character. This indicates that the granules had excellent flow character. The Housners ratio ranged from 0.825 ±0.09 to 0.92 ±0.035 for the different batches. The batches within 1.00 – 1.11 range had excellent flow character while the batches within the range of 0.83-0.825 had good flow character but not as the other batches. The physiochemical evaluations of the amoxicillin granules showed good flow character. All the sample passes friability test with range of 1.0 above except for two sample (corn starch mucilage 5%w/w and 5% microcrystalline cellulose that fall below 1.0%). Uniformity in tablet diameter depends on diameter of the punch use for the compression process the standard deviation permitted is ±5% of the mean diameter (British Pharmacopoeia). To this regard all the tablet passed the test by corresponding to stated standard with the range of 0.57g-0.58g. The standard binder efficiency is <30% to achieve good granule friability, however, the results for all sample shows below 30% this indicate good binding potential in pharmaceutical formulations. For hardness test, they was an increase in values as the concentration increases with the range (CSM 3.96 - 5.5, PTN 2.67 to 4.0 and MCC 3.9 to 4.9) kg respectively.
Table of Contents
1. Introduction
1.1 Background to the study
1.2 Statement of problem
1.3 Aims of the study
1.3.1 Objective of the Study
1.4 Significance of study
1.5 Scope of study
2. Literature Review
2.1 Literature review
2.1.1 Amoxicillin Tablets
2.1.2 Microcrystalline cellulose
2.1.3 Corn Starch Mucilage
2.1.4 Pectin Powder B.P
2.1.4.1 Source and Production
2.1.4.2 Chemical structure
2.1.4.2 Degree of esterification
2.1.4.3 General properties of pectin
2.1.4.4 Gel formation properties of pectin
2.1.4.5 Pharmaceutical uses of pectin
2.2 Tablet
2.2.1 Types of Tablets
2.2.2 Advantages of the Tablets
2.2.3 Tablet Processing
2.3 Excipients
2.3.1 History of Excipients
2.3.2 Classification of Excipients
2.3.3 Excipient Uses and Benefits
2.4.4 Possible Side Effects of Excipients
2.4.5 Excipients Toxicities (cases)
2.6 Lactose Anhydrous as Bulk Agent
2.7 Magnetism Stearate B.P
2.8 Corn Starch as Disintegrant
2.9 Talc Powder
2.10 Amoxicillin
2.10.1 Market Value of the Drug
2.10.2 Drug Resistance
2.10.3 Mode of Action
2.10.4 Physical Properties
2.10.5 Analytical Methodologies
2.10.6 Pharmacokinetic Aspects
2.10.7 Adverse Effects
2.10.8 Drug Interactions
2.10.9 Clinical Indications
3. Materials and Method
3.1 Materials and Equiptment Used
3.2 Methods
3.3 Pre-formulation Studies
3.3.1 Organoleptic Evaluation
3.4 Formulation Studies
3.4.1 Preparation Granules
3.4.1 Flow Properties of Granules
3.4.2 Evaluation of Tablets
3.4.3 Physiochemical Properties
4. Results and Discussion
4.I Results
4.2 Discussion
5. Conclusion and Recommendation
5.1 Conclusion
5.2 Recommendation
Research Objectives and Themes
The primary aim of this research is to perform a comparative analysis of the physicochemical and drug-release properties of 500mg Amoxicillin trihydrate tablets, formulated using different binders—specifically pectin powder B.P, microcrystalline cellulose, and corn starch mucilage—at concentrations of 5%, 7.5%, 10%, and 12.5%. The study evaluates how these variations affect critical quality parameters such as hardness, friability, disintegration time, and dissolution kinetics to establish the most effective and economical formulation.
- Comparative performance of natural versus synthetic binders in amoxicillin tablet stability.
- Evaluation of granule flow properties, including bulk/tapped density and compressibility index.
- Analysis of tablet mechanical integrity through hardness, friability, and weight uniformity tests.
- Impact of binder concentration on *in vitro* dissolution profiles and disintegration times.
Excerpt from the Book
1.1 Background to the study
An ideal drug therapy was based on relating pharmacological response to the dose administered. Poor correlation between the dose administered and pharmacological responses will be resulted because of the decreased absorption rate or poor dose rate (Brahmankar, 2016). Deviation in the plasma drug concentration also will result due to the formulation factors and elimination characteristics resulting in toxicity (Robert, 2017). To reduce these problems an appropriate dosage regimen should be selected, which would attain the plasma concentration immediately after the administration and it should also kept the drug concentration below the maximum safe concentration. This possible by the administration of conventional dosage form in a particular dose at a particular frequency and should be convenient to patient for the administration (Leon, 2015).
Drugs may be administered in various routes in a variety of dosage forms. The most important and popular route of administration is oral route. Because of its popularity and convenience almost every new drug that is newly developed will be tested for its effectiveness as an oral dosage form during its initial stages of formulations (Ainley, 2019).
Dosage forms that are administered through the oral routes are syrups, suspension, elixirs, tablets and tablets. Among these tablets and tablets are the most popular and convenient oral dosage formulations. Tablets offer best protection of the drugs against light, temperature, humidity, oxygen and moisture. Thus it will provide increase stability to the drug and the tablets are tampering proof dosage form (Rawlins, 2018).
Summary of Chapters
CHAPTER ONE: INTRODUCTION: Outlines the study background, problem statement, research aims, and the overall scope of the project regarding binder selection for amoxicillin.
CHAPTER TWO: LITERATURE REVIEW: Reviews existing research on amoxicillin, the role of excipients, and the properties of specific binders like pectin, microcrystalline cellulose, and starch.
CHAPTER THREE: MATERIALS AND METHOD: Details the specific materials, equipment, and experimental protocols used to process and analyze the tablet formulations.
CHAPTER FOUR: RESULTS AND DISCUSSION: Presents experimental data and statistical analysis comparing the physical and release properties of different batches.
CHAPTER FIVE: CONCLUSION AND RECOMMENDATION: Concludes the thesis by confirming the success of the optimized binder formulations and provides recommendations for future pharmaceutical practices.
Keywords
Amoxicillin trihydrate, Cornstarch mucilage, Pectin B.P, Microcrystalline cellulose, Tablet formulation, Excipients, Disintegration time, Friability, Dissolution profile, Granule flow, Physicochemical property, Oral dosage, Binder efficiency, Pharmaceutical quality control, Drug stability.
Frequently Asked Questions
What is the core focus of this research?
The research focuses on conducting a comparative analysis of the physicochemical and drug-release performance of 500mg Amoxicillin trihydrate tablets, utilizing different types and concentrations of binders.
Which specific binders were analyzed in this study?
The study specifically evaluates the efficacy of Pectin powder B.P, Microcrystalline cellulose (MCC), and Corn starch mucilage (CSM) as binding agents.
What is the primary goal of the study?
The aim is to identify optimized binder concentrations that successfully enable the development of an economical Amoxicillin formulation that meets pharmacopeial standards for disintegration and dissolution.
What scientific methods were employed?
The study involved wet granulation and direct compression techniques, followed by standard pharmaceutical tests including angle of repose, bulk density, Carr’s index, hardness, friability, weight uniformity, disintegration, and dissolution studies.
What aspects of tablet performance were treated in the main body?
The research investigates granular properties (flow, density), mechanical attributes (hardness, tensile strength), and biopharmaceutical indicators like moisture content and the release profile (dissolution) of the drug.
Which keywords define this work?
Key terms include Amoxicillin trihydrate, excipients, binding agents, tablet disintegration, drug solubility, and dissolution profiling.
Why is the comparison of different binders essential for Amoxicillin?
Because Amoxicillin can pose bioavailability challenges due to poor solubility; selecting the right binder is critical to ensure proper disintegration and optimized drug release behavior within the standard pharmacopeial limits.
What did the results reveal about binder efficiency?
The results showed that all tested binders (CSM, PTN, and MCC) at optimized concentrations effectively enhanced the binding potential and pharmaceutical quality, leading to successful release patterns and improved mechanical properties for the tablets.
- Quote paper
- Peter Ugwu Akor (Author), 2022, Comparative Analysis of the Physicochemical and Release Properties of Amoxicillin Trihydrate Tablets Formulated with Different Types of Binders, Munich, GRIN Verlag, https://www.grin.com/document/1366972
