Articles

Quality of Oral Liquid Antibiotics and Efficacy

Khondoker Monir Hossen^1*, Md. Abu Sufian², Fatima-tuz-zohra³, Md. Raihan¹, Md Delowar Hosain¹, Fatima Amin¹ and Md Rasel Mia^1
1Bachelor of Public Health, German University Bangladesh.
²Department of Epidemiology, National Institute of Preventive and Social Medicine.
³Department of Public Health, North South University.

Article Info

Received Date: 08 February 2025, Accepted Date: 17 February 2025, Published Date: 20 February 2025
*Corresponding author: Khondoker Monir Hossen, Bachelor of Public Health, German University Bangladesh.
Citation: Khondoker Monir Hossen, Md. Abu Sufian, Fatima-tuz-zohra, Md. Raihan, Md Delowar Hosain, Fatima Amin and Md Rasel Mia. (2025). “Quality of Oral Liquid Antibiotics and Efficacy”. Journal of Public Health Research and Epidemiology, 2(1); DOI: http;/02.2025/JPHRE/013.
Copyright: © 2025 Khondoker Monir Hossen. This is an open-access article distributed under the terms of the Creative Commons Attribution 4. 0 international License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract:

The current study was designed to demonstrate the microbiological quality of oral liquid antibiotics. The in vitro antibacterial potential of the antibiotics was checked. In this regard three samples of oral liquid suspension of Flucoxacillin collected from different drug stores of Dhaka city were tested. All the samples were found to be loaded with total viable bacteria and fungi in the average of 10⁴ cfu/ml and the bacterial and fungal load exceeded United States Pharmacopeia (USP) or British Pharmacopeia (BP) limit (≤10² cfu/ml for bacteria and 10 cfu/ml for fungi). Pathogenic bacteria were also encountered among which Pseudomonas spp. was predominant as they found in all samples. Escherichia coli and Staphylococcus spp. were found in majority of the samples. All the samples of antibiotic exhibited substantial killing effect on E. coli, Staphylococcus spp. and fungi. Flucoxacillin samples had effect on them. E. coli, Klebsiella spp., Staphylococcus spp. and fungi. Flucoxacillin had the elevated antimicrobial effect on Staphylococcus spp.

Key words: oral liquid antibiotics; efficacy.

Background:

Bacterial infections are among the important infectious diseases. Hence, over 5 decades  of extensive researches have been launched for achieving new antimicrobial medicines isolated from different sources for  combating bacterial infections that once ravaged humankind (Kumar et al., 2014, Lovigne et at., 2013). Different antibiotics exercise their inhibitory activity on different pathogenic organisms. Despite progress in development of antibacterial agents, there are still special needs to find new antibacterial agents due to development of multidrug resistant bacteria (Sejal & Priya, 2012).The increasing phenomenon of acquisition of resistance among microorganisms to antimicrobial drugs is attributed to the indiscriminate and improper use of current antimicrobial drugs (Urmi & Noor, 2014). Today, clinically important bacteria are characterized not only by single drug resistance, but also by multiple antibiotic resistances - the legacy of past decades of antimicrobial use and misuse. Drug resistance presents an ever increasing global health threat that involves all major microbial pathogens and antimicrobial drugs. Antibiotics that work today may not work tomorrow. It is essential to investigate newer drugs to which there is lesser resistance (Livermore, 2008). Beside the resistance concern, presence of microorganism in oral suspention liquid (syrup) antibiotic preparation is a great public health concern globally (Cottell, 2011). Contaminations in pharaceutical preparations with microorganisms irrespective of being pathogenic and non-pathogenic can bring about changes in their physical characteristics, breaking of emulsion, fermentation appearance of turbidity or deposit and producing off odors and color changes (Hidalgo, 2013). Moreover, paediatric oral liquid drug formulations may introduce pathogenic microorganisms to infants. Further, these pathogenic organisms may be highly detrimental for immuno-compromised infants. Therefore, microbiological quality of such oral liquid medicines is a very important factor for the above mentioned patients (Haroun & Al-Kayali, 2016). By considering the facts discussed above, the present study was undertaken to investigate the microbiological attributes of commonly available antibiotics  Flucoxacillin.

Materials and Methods:

Liquid suspension of antibiotics such Flucoxacillin of the three different companies (Phylopen –Square, Flux- Opsonin, Revistar- Biopharma) were collected from different drug store of Dhaka City. A total of 250 mg suspension powder of both types of antibiotic were mixed with 10 ml autoclaved distilled water. All the suspensions were then diluted up to 10-2 following standard guidelines. For the enumeration of total viable bacteria and the total fungal load, 0.1 ml of each sample from the dilutions 10-1 and 10-2 was introduced onto the nutrient agar plate (Hi media laboratories Pvt. Ltd Mumbai, India) and Sabouraud’s dextrose agar (SDA) plates (Bhiwadi- 301019, Rajasthan India), respectively, by means of spread plate technique. Plates were incubated at 37 °C for 24 hours and at 25 °C for 48 hours for total viable bacteria and fungi, respectively. From the dilutions 10-1 and 10-2, 0.1 ml of each sample was spread onto the MacConkey agarplate (Hi media laboratories Pvy. Ltd Mumbai, India)for the enumeration of coliforms (especially, Escherichia coli and Klebsiella spp.), respectively. Plates were incubated for 24 hours at 37 °C for  coliforms, correspondingly. Likewise, Staphylococcus spp., Pseudomonas spp., Bacillus spp. were isolated onto Mannitol Salt Agar (MSA) plate (Hi media laboratories Pvt. Ltd Mumbai, India) and Pseudomonas agar plate, Starch agar (Hi media laboratories Pvt. Ltd Mumbai, India) respectively by adding 0.1 ml of diluted sample each, and all the plates were then incubated at 37 °C for 24 hours. All the isolates werebiochemically examined following standard procedures as described earlier. Biochemical testing was performed for selection specific microorganisms such as Triple Sugar Iron Slants (Hi media laboratories Pvy. Ltd Mumbai, India), Methyl-Red (MR), Voges-Proskauer, Motility Indole Urease semisolid medium (Hi media laboratories Pvy. Ltd Mumbai, India), Citrate Utilization Slants (Becton Dickinson and company, France), Catalase test and Oxidase test. Agar well diffusion method was performed  to determine the antimicrobial activity of the Antibiotic samples. Individual bacterial pathogens were spreaded properly over Muller Hinton Agar plates using sterile cotton swabs. Wells were made in MHA by cork borer. Each of the antibiotics were used directly on MHA, separately. Sample solutions were added in wells along with a positive control and a negative control. The presence of antimicrobial activity was determined by the production of a clear zone around the wells and the diameters of these zone s were then measured.

Results & Discussion:

Many factors can increase microbial contamination during consumption includes improper storage conditions, unhygienic handling of the product, not following aseptic procedures when opening of the bottles and reconstituting. Air, water, reconstituting equipment’s, reconstituting personnel and the consumer can be taken as the major sources of microbial contamination of oral liquid drug formulations. There have been an increasing number of reports of infections due to above mentioned reasons (Ahmad & Aqil, 2007). In present study microbial contaminations were evident. All the samples were found to harbor viable bacteria and fungi in average of 104 cfu/mlirrespective of the type of antibiotic tested (Table I). Pseudomonas spp. was predominantly present in all the samples in a range of 102 to 104 cfu/ml. However E.coli and Bacillus spp.were found in six samples in a range of 102 to 103 cfu/ml; whereas, Staphylococcus spp.were encountered in fivesamples. Three samples found to harbor Klebsiella spp. (Table II). Presence of pathogenic bacteria was confirmed by biochemical identification test (Table II). According to USP or BP, the finished products of the oral aqueous preparation should not go over the limit of 102 cfu/ml for total aerobic microbial count and 10 cfu/ml for total yeast mold count. E. coli must be absent from both categories of oral preparations (Noor et al., 2013). The microbial load found in our study clearly exceeded the USP or BP recommended microbial limit. Presence of microorganisms in oral liquid was also previously evident in different formulation of oral liquid drugs in Bangladesh (Noor et al., 2012). Antimicrobial activities of non-antibiotic drugs have been demonstrated in several Studies previously (Noor et al., 2015, Akon et al., 2015, Quaiyum et al., 2014, Sharmin et al., 2014,Sultana et al 2014). Our current study aimed to investigate the antimicrobial effect of locally available oral suspention of antibiotics.All the samples of both Flucoxacillin were effictive in killing of E. C oli, Staphylococcus spp., Klebsiella spp. and fungi. as large zone of inhibition representing sensitivity was found (Table III).  Bacillus spp. were found to acquire resistance against all the samples of Flucoxacillin.

TVB= Total viable bacteria; TFC= Total fungal count

Table 1: Microbial proliferation in Flucoxicillin.

Table 2: Biochemical identification of pathogenic isolates.

Table 3: Antimicrobial activity of antibiotics against laboratory microbial isolates.

Conclusion:

All the oral liquid antibiotic samples contained a significantly higher number of microorganisms including the pathogenic ones. The microbial load exceeded the USP or BP recommended microbial limit to an extent which accounts for high public health concern. Thus, the local pharmaceutical industries need to be more careful and attentive about following the safety rules and standard regulations in all stages of manufacturing, packaging and distribution of the products. The local stores should maintain the appropriate conditions for the storage of the pharmaceutical products. Presence of some resistant pathogenic isolates against the tested antibiotics was also of a major concern.