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Research Article | DOI: https://doi.org/10.31579/2637-8914/165
1 Department of Microbiology, Prince Abubakar Audu University, PMB 1008, Anyigba, Kogi state, Nigeria
2 Department of Science Laboratory Technology, Kogi State Polytechnic, PMB 101, Lokoja, Kogi State, Nigeria
3 Department of Microbiology, Federal University of Technology, PMB 2240, Abeokuta, Ogun State, Nigeria.
*Corresponding Author: Zakari David Adeiza, 1Department of Microbiology, Prince Abubakar Audu University, PMB 1008, Anyigba, Kogi state, Nigeria.
Citation: Adejo P. Omebije, Zakari D. Adeiza, Sule Queen, Edegbo Emmanuel, Akoh P. Queen etc. (2023), Microbiological Quality of Selected Non-Sterile Pharmaceutical Products Retailed in Anyigba, Kogi State, Nigeria, J. Nutrition and Food Processing, 6(9); DOI:10.31579/2637-8914/165
Copyright: © 2023, Zakari David Adeiza. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received: 27 June 2023 | Accepted: 03 November 2023 | Published: 10 November 2023
Keywords: staphylococcus aureus; E.coli; pseudomonas spp; SON;NAFDAC
This study was designed to check for the microbiological quality of non-sterile products retailed in Anyigba. The use of contaminated non-sterile pharmaceutical products can cause hazards in a majority of ways like economic loss to the industrialists, alter the therapeutic effect of the drug and affect the health of a patient. A total of 10 samples were collected; the isolated organisms were characterized and identified by using morphological, cultural and biochemical tests. The organisms isolated were Staphylococcus aureus, E.coli and Pseudomonas spp, Aspergillus spp, Mucorspp, Saccharomyces spp and Rhizopus spp. The percentage of the isolate includes S. aureus 37 (45.7%), E.coli 16 (19.7%) Pseudomonas spp 28 (34.5%) to safeguard the product from contamination, it is important to ensure that good manufacturing practices such as raw material testing, equipment sanitization and automation, microbial testing of water, training of personnel, post marking surveillance, monitoring of environment among others were employed. The focus should also be on surveillance and effective monitoring of the distribution and marketing of pharmaceutical products. Local regulatory agencies such as the Standard Organization of Nigeria (SON), and the National Agency for Food,drug administration and Control (NAFDAC) should always ensure that all pharmaceuticals released into the market for sales and consumption should conform to specifications and are fit for their intended use.
Non-sterile drugs are pharmaceutical products that are not completely free from viable microorganisms or contamination due to the environment in which there are produced and the raw materials used in their formation. Examples of non-sterile drugs: solutions, ointments, creams, powders, capsules and tablets [17].
The pharmaceutical industry is an important element of health all over the world, [17]. Pharmaceutical products are divided into sterile and non-sterile products. Non-sterile pharmaceuticals are not produced by aseptic processes and therefore, are not expected to be free from the degree of contamination in non-sterile products is regulated and is based on the acceptance criteria for microbiological quality established in pharmacopeia monographs [17].
The poor qualities of medicines are not only a health hazard but also a waste of money for both government and consumers [4]. Therefore, the
maintenance of quality with continuous improvement in facilities is very important in pharmaceutical industries [4]. To achieve the quality objective, it is necessary to control all stages of drugs, which covers all matters, which individually or collectively influence the quality of a product, including raw materials, manufacturing the process and the evaluation of the finished product [15].
One of the control stages is the assessment of the microbiological quality of medicinal products [16]. Syrups are viscous oral liquids that may have one or more active ingredients in solution which usually contain large amounts of sucrose or other sugars to which certain polyhydric alcohols may be added to inhibit crystallization or to modify solubilization, taste and other properties [17]. Sugarless syrups may contain sweetening and thickening agents with 95% ethanol being a preservative solvent that incorporates agents, in addition, antimicrobial agents are also added to syrups [17]. The presence of microbes in syrups is a great public health concern globally [17].
Contamination of pharmaceutical preparations with microorganisms irrespective of whether being pathogenic or non-pathogenic can bring about changes in the drugs' physical characteristics, including the breaking of emulsions, fermentation of syrups, and appearance of turbidity or deposit; besides producing possible odours and colour changes. The source of contamination may be from start-up materials, water used during manufacturing, operational equipment, the untidy surrounding environment and through workers, the pharmaceutical manufacturing and packaging environment, raw materials as well as the manufacturing water may attribute to the microbiological spoilage of the finished products [4,6,11]
The presence of a high number of non-pathogenic microorganisms in pharmaceutical products is objectionable as the organisms may deteriorate active ingredients and interfere with the desired activity of the product or generate toxic metabolites [6]. Since non–sterile pharmaceuticals are not produced by aseptic processes and, thus not expected to be free from microbial contaminations which can lead to significant economic loss to the industry as well as morbidity and mortality of the consumers [8].
Inclusion Criteria
This research strictly examines the quality of non-sterile pharmaceutical drugs in the form of tablets, and syrup with various routes of administration and compositions.
Exclusion Criteria
The microbiological quality of sterile drugs will not be inclusive
Sample Collection
The samples to be used include 10 non-sterile drugs which include: Panadol extra, Nifedipine,Ampicillin, Vitamin C, Paracetamol, Diclofenac, Metronidazole,Emzolyn cough syrup,Tutolin Cough Syrup, Moduretic randomly selected from different pharmaceutical retails in Anyigba.
Isolation and quantification of microbial contaminants
Selective and nonselective culture media will be used for quantification and isolation of the microbial contaminants, which are nutrient agar, Saboraud dextrose agar, and MacConkey agar. A 1 mL aliquot of each suspension will be directly plated onto the sterile media and incubated for 24–48 hours at 370c [12]. Pure and single microbial colonies will be subcultured onto solid and liquid media, and incubated at 37°C for 24 hours, and the substantive isolates will be finally stored at 4°C until further use.
Identification of microbiological contaminants
Isolated microbial contaminants will be subjected to standard microbiologic identification tests [5]. This includes;
For bacteria: Gram Staining, Indole test, Citrate utilization test, Catalase test, Coagulase test, Methyl- Red Test, Urease Test and motility test
For fungi: Isolated organisms will be subjected to standard microbiologic identification tests based on cultural characteristics and colony growth morphologies.
Colony forming unit (cfu/ml/g) of the samples on Nutrient agar and MacConkey agar Table 1 shows the bacteria load of the samples analyzed on Nutrient agar and Macconkey agar. Sample A had the highest bacteria load of 1.8
Key: (-) = no growth,
NA - Nutrient Agar, MAC - MacConkey Agar,
A – Panadol extra, B – Vitamin C, C – Nifedipine, D – Ampicillin,
E – Metronidazole, F – Diclofenac, G – Paracetamol, H – Moduretic, I – Emzolyn, J – Tutolin
Table 1: Colony forming unit (cfu/ml/g) of the samples on Nutrient agar and MacConkey agar
Colonial Morphology, Gram Reaction and Biochemical Characteristics Of Bacteria Isolates Sample
Table 2 shows the colony morphology of the different isolates according to their shapes,colour,elevation,edge,consistency,and colony surface.The gram reaction shows the isolate's ability to retain the primary dye (crystal violet) which classifies them as gram-positive and gram-negative
organisms.Also, different biochemical test was used for the identification of the various isolates.
Morphology
Biochemical test
Key Cat = Catalase Met = Methylred(-) = positive, Ind = Indole Ur = Urease (-) = negative (*) = no growth, Mot =motility, Cit = Citrate , Coa= Coagulase
Table 2: Colonial Morphology, Gram Reaction and Biochemical Characteristics of Bacteria Isolates from Samples
Microbial Counts of Non-Sterile Drugs Samples
Table 3 shows the accepted microbial limits of bacteria for non-sterile Pharmaceutical products [18] Sample A wasmicrobiologically unacceptable because the Total Viable Bacteria Count exceed the limits 103cfu/g/ml. Sample B was also microbiologically unaccepted because the specified organism E.coi is present, Sample D was microbiologically unacceptable because the Total Viable Bacteria (TVBC) exceed the accepted. While other samples were microbiologically acceptable.
Table 3: Microbial Counts of Non-Sterile Drugs Samples
Accepted microbial limits of bacteria for non-sterile oral drugs [18]
KEY: TVBC = total viable bacteria count (-) = no growth
(*102 cells/ml) = the Acceptable microbial limits of bacteria for syrup
(*103 cells/g) = the Acceptable microbial limits of bacteria for the tablet.
Frequency Occurrence of Bacteria Isolate from Non-Sterile Pharmaceutical Products
Key: A – Panadol extra, B – Vitamin C,C – Nifedipine, D– Ampicillin,
E– Metronidazole, F – Diclofenac, G – Paracetamol, H– Moduretic,
I – Emzolyn,J – Tutolin.
Table 4: shows the frequency of occurrence of bacterial isolates. Staphylococcus aureus had the highest frequency with 37(45.7%) and E.coli had the least frequency with 16(19.7%)
Colonial Morphology of Fungi Isolated from Non-Sterile Pharmaceutical Products.
Table 5 shows the colonial morphology of fungi isolated from the non-sterile pharmaceutical product according to their spore, septate or non-septate hyphae, texture, and description of the colony on media. The probable organisms isolated include Aspergillus spp, Mucor spp, Penicillium spp, Rhizopus spp and Saccharomyces spp.
Key:(-) = No Growth
Table 5: Colonial Morphology of Fungi Isolated from Non-Sterile Pharmaceutical Product.
The result of this study showed that the microbial load in tablets is high while the syrup produces no growth. They include sample A (Panadol extra) is 1.8
Most of the brand's non-sterile pharmaceutical products sold in outlets in Anyigba were found to contain various levels of microbial contaminants which may constitute a public health concern and economic problem. A significant number of microorganisms isolated from the sample were either from human sources or from airborne. Local regulatory agencies such as the Standathe rd Organization of Nigeria (SON), and the National Agency for Food, drug administration and Control (NAFDAC) should always ensure that all pharmaceuticals products released to the market for consumption and sales should conform to specifications and fit for their intended use.
Non-sterile preparations have less stringent requirements regarding the exclusion of microbes. They need not be sterile but it has to be shown that some specifically named organisms are not present in them [18].
The result of this study showed that the microbial load in tablets is high while the syrup produces no growth. They include sample A (Panadol extra) is 1.8
Most of the brand's non-sterile pharmaceutical products sold in outlets in Anyigba were found to contain various levels of microbial contaminants which may constitute a public health concern and economic problem. A significant number of microorganisms isolated from the sample were either from human sources or from airborne. Local regulatory agencies such as the Standathe rd Organization of Nigeria (SON), and the National Agency for Food, drug administration and Control (NAFDAC) should always ensure that all pharmaceuticals products released to the market for consumption and sales should conform to specifications and fit for their intended use.
Non-sterile preparations have less stringent requirements regarding the exclusion of microbes. They need not be sterile but it has to be shown that some specifically named organisms are not present in them [18].
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