MICROBIOLOGICAL QUALITY OF EXPIRED AND NON EXPIRED VITAMIN C SYRUPS

ABSTRACT

This study was to evaluate the microbiological quality of expired and non expired vitamin C syrups sold in Umuahia metropolis. The bacterial isolates from the syrup samples were identified by morphological characteristics, pigmentation on media, microscopy, biochemical test. This bacteria isolated were Staphylococcus aureus, Escherichia coli, Salmonella species, and Bacillus species respectively, while the fungi isolated were; Aspergillus niger and Aspergillus flavus. The total bacteria counts ranged from 1.0x105 to 9.7x104, while the fungi counts ranged from 1.01 x105 to 5.2x104. Amongst the expired syrup samples investigated for its microbiological quality however within Umuahia, Sample 8 had the highest bacteria count of 9.7x104 (cfu/ml), followed by Sample 2 (7.1x104cfu/ml), while the least bacteria count was recorded for Sample 3 (1.7x105cfu/ml). The total fungal plate count investigated on the different syrup samples, reveals sample 7 as having the highest fungi count at 5.2x104 (cfu/ml) and sample 5 having the least viable fungi count at ­­1.01x105 (cfu/ml). These values are higher when compared to non-expired syrup samples. The contamination rate and percentage distribution accessed on the both expired and non-expired vitamin C and Multivitamin Syrup revealed that Staphylococcus aureus is the most frequently occurring isolates with a high percentage occurrence of (30.0%) followed by Escherichia coli (22.5%). However, there were wide variations in the fungi population, with Aspergillus flavus (15.0%) being most predominant and occurring isolates. However the result showed clearly that more microorganisms were isolated from the expired Multivitamin and Vitamin C syrups. Failure to apply good and sound manufacturing practices can lead to microbial contaminations and as such the overall quality of the final product suffers a huge reduction. Therefore, it is safe to buy and consume non-expired drugs against the expired drugs.

TABLE OF CONTENTS

Title Page                                                                                                                                i

Certification                                                                                                                           iii

Dedication                                                                                                                              iv

Acknowledgement                                                                                                                  v

Table of Contents                                                                                                                   vi

List of Tables                                                                                                                          ix

Abstract                                                                                                                                  x

CHAPTER ONE: Introduction                                                                                             1

1.1       Aim and Objectives                                                                                                    3

CHAPTER TWO: Literature Review                                                                                  5

2.1       The vitamins                                                                                                               5

2.1.1    Functions of the Vitamins                                                                                          5

2.2       Syrups                                                                                                                         7

2.2.1    Methods of Preparing Syrups                                                                                     8

2.2.2    Pointers for a Successful Preparation of Syrups Using Percolation Method                        10

2.2.3    Preservation of Syrups                                                                                                11

2.3       Multivitamin Syrups and Its Composition                                                                 12

2.4       Contamination of Syrups                                                                                            13

2.4.1    Significance of microbial contamination of syrups                                                    16

2.4.1.1 Spoilage                                                                                                                      16

2.4.1.2 Hazard to health                                                                                                         17

CHAPTER THREE: Materials and Methods                                                                      18

3.1       Sample Collection                                                                                                      18

3.2       Microbial Analysis                                                                                                     18

3.3       Media Used                                                                                                                 18

3.3.1    Preparation of Culture Media                                                                                     18

3.3.2    Sterilization Method                                                                                                   19

3.4       Sample Preparation and Isolation of Microorganisms                                               20

3.4.1    Sample Inoculation                                                                                                     20

3.4.2    Quantitative Estimation of Bacteria and Fungi Isolates                                             20

3.4.3    Purification of Isolates                                                                                               20

3.5       Microbial Characterization and Identification                                                           21

3.5.1    Gram Staining Techniques                                                                                         21

3.6       Identification of Fungal Isolates                                                                                 24

3.6.1    Wet Preparation                                                                                                          24

3.6.2    Colonial Morphology                                                                                                 24

CHAPTER FOUR: Result                                                                                                    25

CHAPTER FIVE: Discussion, Conclusion and Recommendations                                     32

5.1       Discussion                                                                                                                   32

5.2       Conclusion                                                                                                                  35

5.3       Recommendations                                                                                                      35

            References

LIST OF TABLES

CHAPTER ONE

1.0       INTRODUCTION

Pharmaceutical products are supposed to be free of microbial contaminants even upon expiration. Occasionally, these drugs when not compounded under proper hygienic or storage conditions may become contaminated by microorganisms, which survive and multiply in them (Takon and Antai, 2006). The microbial quality of pharmaceutical products primarily depends on the quality of raw materials, production process, production environment, hygiene of the personnel involved in manufacture and the storage conditions. Not only the presence of pathogenic microorganisms but the presence of relatively high number of non-pathogenic microorganisms is also objectionable in pharmaceutical products. The presence of high number of non-pathogenic microorganisms in pharmaceutical products is objectionable for two reasons: firstly, these microorganisms can deteriorate active ingredients and can interfere with the desired activity of the product; and secondly, they can produce some metabolites that may be toxic to the consumer.

However, vitamin C syrups are considered semi-sterile because they are not always manufactured under sterile conditions (Mendie, 2003). For this reason, during the production of vitamin C syrups very strict standard are required so as to reduce to the minimum the microbial load of the final product. In order to ensure the elimination of production errors, the manufacturing and design details has to meet the high quality requirement of the global recognition because the syrup have to be effective for the therapeutic purpose for which it is being produced and prescribed, free from any type of side effect to any patient that uses it (Baker et al., 2008). Chemical and microbial load and physical factors can aid in the cause of the side effect in the syrup when they are not properly controlled during the period of their production.

Multivitamins and vitamin C syrups include the six classes of food that are required in a very small amount for healthy growth of humans especially children; therefore they are essential constituent of the human diet (Takon and Antai, 2006).

Vitamins are divided into two groups according to whether they are soluble in water or fat. Water soluble group include vitamin B complex and vitamin C. Fat soluble group include vitamins A,D,E and K. Lack of sufficient quantity of any of these vitamins in the body system result in a specific vitamin deficiency disease. B-group vitamins as coenzymes or co-factors and have a critical role in the metabolism of carbohydrates, proteins, and lipids. However, they are unable to be synthesized by tissues in sufficient amounts; therefore, their deficiency or excess in the human body depends on the dietary consumption and supplementation to either which insufficient or excess vitamin consumption could lead to serious dieses (Albala-Hurtado et al., 2008). Although, the main resource for obtaining B group vitamins is from the diet, these vitamins are unstable and easily destroyed and/or degraded by heat, light, oxygen, and other food components. They are also subject to loss during food processing, cooking and long periods of storage. It is well known that insufficient levels of vitamins can cause many problems in maintenance of body functions and normal growth (Chen et al., 2009). For this reason, many foods are supplemented with vitamins, especially for infant and baby products in order to meet the nutritional requirements.

In addition, the use of a multivitamin supplement is another way to circumvent the lack of sufficient dietary intake of vitamins and decrease the risk of hypovitaminosis, as a consequence of malabsorption, bad eating habits, pregnancy, or acute and chronic diseases. Vitamin C also known as ascorbic acid has an antioxidant property that is essential in maintaining healthy connective tissues and the integrity of cell walls and for the synthesis of collagen (Mendie, 2003). Deficiency of vitamin C leads to a disease condition known as scurvy. In order to prevent this disease, 30g of vitamin C is recommended daily (Dela, 2005). Microbial contamination of syrups is not actually the problem because man in nature is always in contact with microorganism through air breath, food and contaminated surfaces. However, microbial contamination of syrups becomes a problem when it leads to a side effect and death of patient that consumes the product (Ibezim et al., 2002). 

In view of the side effects of microbial contaminated syrups, it is expected that regulatory bodies responsible for licensing the manufacture of pharmaceutical products should always ensure that microbial contamination of the products are limited and are within the body’s standard requirement so as to avoid side effect or infection and they are also to ensure that specified type(s) of microorganism(s) are restricted throughout the product shelf life.  Escherichia coli and Salmonella spp are always restricted from oral product because they cause gastro intestinal infection. So these species are used as indicator organisms (Lillehaug et al., 2005). When contamination is discovered in a pharmaceutical product, the product must be evaluated considering the formulation of the product, its method of delivery, the contaminant and the type of patient undergoing the treatment (whether children or adult). Microbial contamination of raw material used for manufacturing multivitamins and vitamin C syrups are often reduced during manufacturing. The amount of microbial reduction is often directly dependent on the process, temperature, chemical properties of the drug formulation and metabolic properties of the contamination microbes (Baker et al., 2008). It is expected of the manufacturing companies to therefore, adhere strictly to the minimum level of microbial contamination during drug manufacturing process and ensure that the restricted species of microbes are not in the finished product to ensure the safety of the patients.

1.1       AIM AND OBJECTIVES

The main aim this study is to evaluate the microbiological quality of expired and non expired vitamin C syrups sold in Umuahia.

1.1.1    Specific Objectives

·       To determine the total microbial counts from expired and non-expired vitamin C syrups sample.

·       To isolate and identify microbial species associated with expired and non–expired vitamin C syrups sample.

·       To determine and compare the microbiological quality of expired and non–expired vitamin C syrups.

·       To determine the percentage occurrence of fungi and bacteria isolates from the vitamin C syrups sample.  

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