Antimicrobial Effectiveness Test Research Articles

A Stable Fixed-Dose Combination of Benzalkonium chloride-free Latanoprost and Once-a-day Timolol

Abstract Objective This study outlines the development of a stable fixed dose combination solution formulation of Benzalkonium chloride (BKC)-free latanoprost with once-a-day timolol in a gel-free reservoir (GFR) vehicle. Methods A fixed-dose combination (FDC) formulation of latanoprost and timolol maleate was prepared by mixing polymers, buffers, and ionic preservatives followed by parylene coating of plastic bottles that were used for stability studies. Key findings The FDC formulation was a clear, colorless, slightly viscous solution. The adsorption of latanoprost on the parylene coated plastic bottle surface was reduced. Promoting stability for 36 months. The assay and impurities and other physicochemical quality attributes, such as color, clarity, osmolality, and pH met the required standards of both latanoprost and timolol. The sterility and antimicrobial effectiveness testing (AET) also complied with the United States Pharmacopeia (USP) requirements. Stability was proven for 30 days in simulated in-use conditions. It showed clinically relevant (>2 mm Hg) intraocular pressure (IOP) reduction in a normotensive dog model. It also showed an higher IOP reduction (efficacy) over individual or concomitantly administered drug components and numerically better IOP reduction than the marketed FDC formulation in a conventional vehicle. Faster action was seen within 2-h on first day and recovery took 5 days post treatment cessation. Conclusion A stable FDC formulation in parylene-coated plastic bottles was successfully developed meeting the clinically relevant IOP reduction criteria. Comparable efficacy insptto existing treatment, this FDC is preferable option for patients with conditions such as dry eye and ocular surface disease.

QbD Based Formulation Development and Optimisation of Ozenoxacin Topical Nano-Emulgel and Efficacy Evaluation Using Impetigo Mice Model.

To formulate and optimize Ozenoxacin nano-emulsion using Quality by Design (QbD) concept by means of Box-Behnken Design (BBD) and converting it to a gel to form Ozenoxacin nano-emulgel followed by physico-chemical, in-vitro, ex-vivo and in-vivo evaluation. This study demonstrates the application of QbD methodology for the development and optimization of an effective topical nanoemulgel formulation for the treatment of Impetigo focusing on the selection of appropriate excipients, optimization of formulation and process variables, and characterization of critical quality attributes. BBD was used to study the effect of "% of oil, % of Smix and homogenization speed" on critical quality attributes "globule size and % entrapment efficiency" for the optimisation of Ozenoxacin Nano-emulsion. Ozenoxacin loaded nano-emulgel was characterized for "description, identification, pH, specific gravity, amplitude sweep, viscosity, assay, organic impurities, antimicrobial effectiveness testing, in-vitro release testing, ex-vivo permeation testing, skin retention and in-vivo anti-bacterial activity". In-vitro release and ex-vivo permeation, skin retention and in-vivo anti-bacterial activity were found to be significantly (p < 0.01) higher for the nano-emulgel formulation compared to the innovator formulation (OZANEX™). Antimicrobial effectiveness testing was performed and found that even at 70% label claim of benzoic acid is effective to inhibit microbial growth in the drug product. The systematic application of QbD principles facilitated the successful development and optimization of a Ozenoxacin Nano-Emulsion. Optimised Ozenoxacin Nano-Emulgel can be considered as an effective alternative and found to be stable at least for 6months at 40°C / 75% RH and 30°C / 75% RH.

Antimicrobial Effectiveness Testing of Resorbable Electrospun Fiber Matrix per United States Pharmacopeia (USP) .

Contamination of surgical, traumatic, and chronic wounds with microorganisms presents a challenge to successful wound healing. In the present in vitro study, a syntheticelectrospun fiber matrix (SEFM) cleared for use in the management of chronic, surgical, and traumatic wounds underwent USP (United States Pharmacopeia) <51> Antimicrobial Effectiveness Testing to determine its in vitro effectiveness against various microorganisms commonly found in non-healing wounds. The SEFM was tested in both sheet (s-SEFM) and micronized form (m-SEFM) againstEscherichia coli, Pseudomonas aeruginosa,Staphylococcus aureus,Aspergillus brasiliensis,Candida albicans,Proteus mirabilis, andEnterococcus faecalis. Testing was performed per the USP <51> standard on days 7, 14, and 28. Both the s-SEFM and m-SEFM met the USP <51> acceptance criteria for all microorganisms. The results obtained for s-SEFM demonstrated >1-log10reduction againstE. coli, S. aureus, P. aeruginosa, P. mirabilis, E. faecalis,andC. albicansat day 7; >3-log10reduction with no detection of these microbes at days 14 and 28, and no increase from initial inoculum at days 7, 14, and 28 againstA. brasiliensis.The results obtained for m-SEFM demonstrated >3-log10reduction with no detectable microorganisms at day 7. The results observed in this study indicate that the SEFM is effective in vitro at inhibiting bacterial and fungalgrowth and colonization per USP <51> testing.

Compounded Hair Solutions and Foams Containing Minoxidil: Does the Color Change Impact Stability?

An increasing number of pharmacies around the world are producing hair solutions and foams containing minoxidil for alopecia, commonly using ready-to-use vehicles such as TrichoSolTM or TrichoFoamTM. However, it is paramount to determine the chemical and microbiological compatibility of these formulations so they can be safely implemented as vehicles of choice. Also, these products usually suffer from a change of color over time, which leads to many patients prematurely discontinuing treatment. As long-term treatment is recommended, this study aimed to assess the physical–chemical and microbiological stability and investigate the color change of compounded minoxidil formulations. For that, HPLC analyses and antimicrobial effectiveness testing were conducted in a bracketed study covering concentrations from 1.0% to 7.0% of minoxidil. HPLC, pH, and metals in 5.0% minoxidil compounded products were determined using ICP-MS to evaluate the mechanisms involved in their color change. The stability of the products varied from 120 to 380 days. The color change was remarkably noticeable, but apart from this parameter, no other quality attribute was affected throughout this period, including minoxidil content, which presented only minor fluctuations. No precipitation was observed, and pH was relatively stable. It is not expected that this yellow color will impact effectiveness. Finally, we created an indicative color chart of the behavior of minoxidil in the studied vehicles.

Preparation of Semi-Solid Dosage Forms Containing Psidium Guava Leaves Extract as Antimicrobial Preservative

Guava leaves extract has several medicinal activities as antimicrobial, antioxidant, anti-cancer and anti-inflammatory. Several studies have been proposed to use guava leaves extract in several preparations. However, applying guava leaves extract as a preservative in a pharmaceutical product has not been studied previously. In the present work, Guava leaves extract was used as natural preservative instead of chemical ones (methyl and propyl paraben). Guava leaves were extracted with ethanol 95% as extraction solvent with a percentage yield of 20%. This extract was tested by HPLC; several phenolic compounds were detected. To determine the ability to use this extract as a preservative, antimicrobial effectiveness test (preservative efficacy test) was conducted for extracted powder in purified water at different concentrations (0.5, 1.0, 1.5, and 2.0 % w/w), against three bacteria, one gram-positive (S. aureus), two gram-negative (P. aeruginosa, E. coli) and two fungi: one yeast (Candida albicans) and one mold (Aspergillus (Niger) brasiliensis). Results showed that 2% was effective and passed the test of preservative effectiveness test; this concentration was used in semi-solid pharmaceutical products. For this purpose, six different preparations (Ketoconazole shampoo, Clotrimazole Cream, Permethrin Cream, Gentamycin Cream, Ibuprofen gel, Indomethacin emulgel) were used. Chemical preservative was replaced by natural one (guava leaves extract powder) to serve as a preservative. Three out of the six preparations (Ketoconazole shampoo, Clotrimazole Cream, Ibuprofen gel,) passed preservative efficacy test. These preparations were fully checked-up by chemical (drug content,) physical (odor, physical appearance) and biological test (total count test) for three months at accelerated conditions. These results confirmed that these pharmaceutical preparations were stable and effective. As a conclusion Guava leaves extract can be used at 2% as natural preservative instead of chemical ones which have adverse side effects on human health.

Compatibility of Personalized Formulations in Cleoderm™, A Skin Rebalancing Cream Base for Oily and Sensitive Skin

Inflammatory skin conditions are prevalent in the general population and are a source of much concern for those who suffer from them. Acne is an extremely common condition and can significantly impact the quality of life of affected patients. Rosacea is another common dermatological disorder that often affects the face and can present with flushing, irritated skin, and pimples. In addition to being key for acne and rosacea, inflammation can also play a role in prematurely aging skin and contributes to the formation of wrinkles. Given the prevalence and patient impact of dermatological conditions on the face, such as those previously described, there is a demand for personalized medicines to manage these conditions when commercially available options are unsuitable, unavailable, or insufficient to fully resolve the condition. When designing an appropriate personalized therapy for a patient, both the vehicle and the active pharmaceutical ingredient choices are key to the success of the treatment. Cleoderm™ is a topical cream designed for use as a vehicle for the preparation of dermatological treatments by compounding pharmacies. Its ingredient profile was specifically curated to be gentle on the skin, allowing its use as a vehicle for compounded preparations that may be applied to sensitive and affected skin. In this bracketed study, benzoyl peroxide, cyproterone acetate, estriol, metronidazole, niacinamide, progesterone, retinoic acid, spironolactone, and tranexamic acid were selected, due to their known applications for dermatological skin conditions. To evaluate the compatibility and stability of Cleoderm™ in these formulations, high-performance liquid chromatography, followed by antimicrobial effectiveness testing, were performed for 180 days. For most formulations, a beyond-use date of 180 days was observed when stored at room temperature, except for retinoic acid, which had a beyond-use date of 30 days. Through the outcomes of this study, we concluded that Cleoderm™ presents increased convenience for both the compounding pharmacist and the patient, suggesting that it is an adequate candidate vehicle for compounding different dermatological formulations with adequate stability, presenting itself as a good alternative to commercially available treatments that cannot be personalized.

Evaluation of preservative effectiveness in some eye drops in Syrian market by antimicrobial effectiveness test according to different pharmacopeias

Evaluation of preservative effectiveness in some eye drops in Syrian market by antimicrobial effectiveness test according to different pharmacopeias

Physicochemical and Microbiological Stability of Two Oral Solutions of Methadone Hydrochloride 10 mg/mL.

In this article, we studied physicochemical and microbiological stability and determined the beyond-use date of two oral solutions of methadone in three storage conditions. For this, two oral solutions of methadone (10 mg/mL) were prepared, with and without parabens, as preservatives. They were packed in amber glass vials kept unopened until the day of the test, and in a multi-dose umber glass bottle opened daily. They were stored at 5 ± 3 °C, 25 ± 2 °C and 40 ± 2 °C. pH, clarity, and organoleptic characteristics were obtained. A stability-indicating high-performance liquid chromatography method was used to determine methadone. Microbiological quality was studied and antimicrobial effectiveness testing was also determined following European Pharmacopoeia guidelines. Samples were analyzed at days 0, 7, 14, 21, 28, 42, 56, 70, and 91 in triplicate. After 91 days of storage, pH remained stable at about 6.5–7 in the two solutions, ensuring no risk of methadone precipitation. The organoleptic characteristics remained stable (colorless, odorless, and bitter taste). The absence of particles was confirmed. No differences were found with the use of preservatives. Methadone concentration remained within 95–105% in all samples. No microbial growth was observed. Hence, the two oral methadone solutions were physically and microbiologically stable at 5 ± 3 °C, 25 ± 2 °C, and 40 ± 2 °C for 91 days in closed and opened amber glass bottles.

Methylparaben as a preservative in the development of a multi-dose HPV-2 vaccine

ABSTRACT The human papillomavirus (HPV) vaccine is the simplest, most economical, convenient, and effective method of preventing cervical cancer. However, the current HPV vaccine is supplied as a single-dose vial with a relatively high cost per dose, which hinders its supply to low- and middle-income countries (LMICs), where the demand for HPV vaccine is highest. Therefore, it is necessary to develop a multi-dose HPV vaccine to promote large-scale affordable vaccination in LMICs. Moreover, the addition of preservatives is required to reduce the risk of microbial contamination in multi-dose vaccines within a single vial. In this study, we investigated the effects of six preservatives on HPV 16L1 and 18L1 virus-like particles in solution, as well as the aluminum adsorption status, under normal and high-temperature conditions. Multiple methods were employed, including dynamic light scattering, differential scanning calorimetry, an in vitro relative potency assay, and an in vivo potency assay in mice. Based on the above results, four types of selected preservatives were further studied, and an antimicrobial effectiveness test was performed on the HPV-2 vaccine, which was employed as a model HPV vaccine. Finally, three preservatives were selected based on their performance to evaluate the long-term stability of the HPV-2 vaccine. The results indicated that 0.12% methylparaben is the most suitable preservative for the multi-dose HPV-2 vaccine, guaranteeing the shelf life for at least three years and meeting “B” standards for antimicrobial effectiveness. The formula developed in this study can contribute toward combating cervical cancer in LMICs.

Aktivitas Antibakteri dan Analisis Fitokimia Ekstrak Metanol dari Daun Paku Sarang Burung (Asplenium nidus)

Infectious diseases caused by microbes are increasing; the growth of microbes can be inhibited by using antibiotics. Continuous and inappropriate use of antibiotics causes microbes to become resistant. The resistance can be reduced by finding new sources of antibiotics, one of which is from the bird nest fern (Asplenium nidus). This study aimed to determine the potency and concentration of A. Nidus extract in inhibiting the growth of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 15442, and Bacillus subtilis ATCC 19659. The extract was prepared using the maceration method with methanol as the solvent. Phytochemical tests include alkaloids, flavonoids, steroids, terpenoids, saponins, phenolics, tannins, and quinones. The minimum inhibitory concentration test was carried out on 12 treatments with three replications; the antimicrobial effectiveness test was carried out on seven treatments with five replications using the disc diffusion method. Phytochemical test results showed A. Nidus contains flavonoids, tannins, saponins, and phenolics. A. nidus extract has the potential to inhibit the growth of the testing pathogenic bacteria, with the most effective concentration on P. aeruginosa of 45% with an inhibitory zone was about 14,16 mm, on E. Coli started of 55% with an inhibitory zone was about 13,68 mm, on B. Subtilis of 65% with an inhibitory zone was about 14,80 mm and S. aureus was 75% with an inhibitory zone of 11,96 mm.&#x0D; &#x0D; Keywords: antibiotics, Asplenium nidus, Infectious disease

Formulation and Evaluation of Alcohol-Free Hand Sanitizer Gels to Prevent the Spread of Infections during Pandemics.

Hand hygiene is an essential factor to prevent or minimize the spread of infections. The ability to prepare an alcohol-free hand sanitizer (AFHS) with antimicrobial properties is crucial, especially during pandemics, when there are high demands and a low supply chain for ethanol and isopropanol. The objective of this study was to prepare AFHS gels based on natural materials that contain essential oils (EOs) that would be effective against a broad spectrum of pathogens. The results showed that the organoleptic characteristics of all prepared hand sanitizer gels were considered acceptable. The pH of the formulations was slightly acidic (circa 3.9) owing to the presence of aloe vera in large proportions (90% v/v), which is known for its acidity. The spreadability for all tested formulations was in the acceptable range. The antimicrobial effectiveness test demonstrated that the prepared hand sanitizer gels had antimicrobial activities against different gram-positive and gram-negative bacteria and Candida albicans yeast. The highest antibacterial effect was observed with tea tree oil hand sanitizers, which lack activity against the yeast, while clove oil hand sanitizers showed effectiveness against all microorganisms, including Candida albicans. The lavender hand sanitizer exhibited the least antimicrobial efficiency. The acceptability study on 20 human volunteers showed that the hand sanitizer gel containing 1.25% (v/v) clove oil did not produce any signs of skin irritation. This study suggested that the prepared natural hand sanitizer gel with 1.25% (v/v) clove oil can be a potential alternative to commonly used alcohol-based hand sanitizers (ABHS).

Why it’s time to strengthen and widen the microbial test panel

The testing of culture media, and conducting microbiological method suitability studies, disinfectant efficacy studies, Antimicrobial Effectiveness Test (or Preservative Efficacy Test) and associated activities, requires the use of a test panel of microorganisms. These organisms need to be representative of the intended application and be of a suitable range in order to demonstrate that a low level of viable cells can be recovered without any indication of the inhibition of growth or excessive growth-promotion (typically defined as the recovery of between 50 to 200% of the challenge count). This activity provides the basis for the release of culture media or for verifying that a method is suitable for recovering any microorganisms that might be present in a product sample. This approach has been established for several decades and in many cases the types of organisms selected for the panel are drawn from guidance presented in the major pharmacopeia. The test panels of organisms recommended by compendia along with specific standards are in place to allow for reproducibility between laboratories. In the case of most standards (such as the disinfectant efficacy norms), these are designed to be multi-industry. Hence the presented organisms may or may not be suitable for the intended application. In addition, with the compendia, all too often the organisms recommended for, say, the Microbial Limit Test method verification, are applied to the release of all culture media used for all activities, be that the test for sterility or for the recovery of organisms from water systems. Not only is this inappropriate – for the microbiologist should be reviewing the panel and deciding upon the appropriate organisms – the recommended panels have not kept pace with improvements with our understanding of the types of microorganisms likely to cause contamination. Take, for example, the inclusion of Salmonella in the panel for the recovery of so-called ‘objectionable microorganisms’ for use with the Microbial Limits Test ¹. To my knowledge and based on discussions with microbiologists over a couple of decades, no Salmonella has ever been recovered from a raw material. Equally the selection, especially in relation to the testing of culture media used for cleanroom environmental monitoring, has not moved forwards with the findings from the human microbiome project and the depth of species richness found on the human skin microbiome. The argument that the test panel quoted in the compendia is representative and thus if culture media release testing can recover such organisms then it can reasonably be assumed that any other similar organisms can be recovered does not really hold up. Unless, that is, the only concern is with the recovery of non-fastidious mesophilic organisms. Instead, I maintain that in terms of the appropriate panel, this should be based on: • What is currently being recovered, and • What should theoretically be recovered.

Antimicrobial activity of topical dyes used in clinical veterinary ophthalmology.

To evaluate in vitro the antibacterial effects of fluorescein, rose bengal, and lissamine green topical ophthalmic dyes against selected Gram-positive and Gram-negative bacteria, and to evaluate whether preserved or preservative-free fluorescein solutions are able to inhibit or potentiate bacterial growth. Susceptibility testing was performed using the Kirby-Bauer disk diffusion method plated with clinical ocular isolates of Staphylococcus aureus, Staphylococcus pseudintermedius, Streptococcus spp., Escherichia coli, and Pseudomonas aeruginosa. Bacterial growth inhibition was evaluated 24hours following the addition of commercially available fluorescein, rose bengal, and lissamine green sterile strips. Antimicrobial effectiveness testing was performed by inoculation of compounded 1% dye solutions, both with and without preservatives (fluorescein and lissamine contained thiomersal, and rose bengal contained nipagin and nepazol), with the five previously mentioned bacteria. Growth was evaluated at days 7, 14, and 28. All dyes showed antibacterial activity against Gram-positive organisms. Preservative-free compounded 1% fluorescein solution inhibited growth of Gram-positive organisms but not of Gram-negative organisms. Preservative-free rose bengal and lissamine green inhibited growth of both types of organisms. Preferably, ocular surface samples for antimicrobial culture should be taken prior to the administration of topical dyes, due to their potential antibacterial activity, particularly if undiluted strips are applied directly or commercial fluorescein solutions are used and not immediately rinsed. Ophthalmic dye solutions containing preservative are safe from bacterial growth for up to 28days if properly handled and stored. The use of preservative-free fluorescein solutions should be avoided and preservative-free rose bengal and lissamine green should be handled carefully.

Customized antimicrobial efficacy tests offer superior evaluation of growth inhibitor efficacy for liquid microbial products

Antimicrobial effectiveness tests are common methods used to assess the risk of microbial contamination in pharmaceuticals and cosmetics. These assays may be inappropriate for endospore-based microbial products which often carry a similar – if not greater – risk of microbial contamination. In the present study, we compared the antimicrobial efficacy assessment provided by United States Pharmacopeia Chapter <51> Antimicrobial Effectiveness Testing with a modified test which utilized a customized bacterial challenge. The customized challenge inoculum comprised an assemblage of 12 bacterial strains (both pathogens and spoilage organisms) isolated from the product's end-use geography. Results suggest that some microbial inhibitor systems which pass industry standard antimicrobial effectiveness tests may fail when challenged with a customized bacterial assemblage. In order to provide the best possible assessment of microbial inhibitor systems for liquid Bacillus products, we suggest that new antimicrobial effectiveness tests be developed for this product class which include the addition of field-relevant contaminants in addition to the industry standard pathogen challenge.

Development of a safe and versatile suspension vehicle for pediatric use: Formulation development.

This project aimed to develop a suspension vehicle specifically designed for pediatric use. Excipients were selected according to their safety and recorded use in pediatrics. Two suspension vehicles were formulated at neutral and acidic pH. A few compositions were defined, and their physicochemical properties assessed and compared to readily-available commercial vehicles. As required for a multidose oral formulation, an antimicrobial effectiveness test was conducted according to the USP. Different microbial strains were inoculated individually in each formulation and their concentrations monitored for 28 days. Propionic acid proved to be an effective preservative against all tested strains at pH 4.5. All tested preservative failed the test at pH 7.5. The final version of the novel vehicle presented a pH of 4.5 and a viscosity of 85 cP at 25 °C. A clear shear-thinning behaviour could be observed. These properties warranted an adequate physical stability and resuspendability, when tested with prednisolone and acetaminophen tablets. A slight reduction of the viscosity was reported when stored at room temperature, but the pH remained constant for 180 days in refrigerated conditions and at room temperature. The final result is a ready-to-use compounding vehicle, containing minimal excipients, safe for children's use and stable for 6 months.

Ionic silver functionalized ovine forestomach matrix \u2013 a non-cytotoxic antimicrobial biomaterial for tissue regeneration applications

BackgroundAntimicrobial technologies, including silver-containing medical devices, are increasingly utilized in clinical regimens to mitigate risks of microbial colonization. Silver-functionalized resorbable biomaterials for use in wound management and tissue regeneration applications have a narrow therapeutic index where antimicrobial effectiveness may be outweighed by adverse cytotoxicity. We examined the effects of ionic silver functionalization of an extracellular matrix (ECM) biomaterial derived from ovine forestomach (OFM-Ag) in terms of material properties, antimicrobial effectiveness and cytotoxicity profile.MethodsMaterial properties of OFM-Ag were assessed by via biochemical analysis, microscopy, atomic absorption spectroscopy (AAS) and differential scanning calorimetry. The silver release profile of OFM-Ag was profiled by AAS and antimicrobial effectiveness testing utilized to determine the minimum effective concentration of silver in OFM-Ag in addition to the antimicrobial spectrum and wear time. Biofilm prevention properties of OFM-Ag in comparison to silver containing collagen dressing materials was quantified via in vitro crystal violet assay using a polymicrobial model. Toxicity of ionic silver, OFM-Ag and silver containing collagen dressing materials was assessed toward mammalian fibroblasts using elution cytoxicity testing.ResultsOFM-Ag retained the native ECM compositional and structural characteristic of non-silver functionalized ECM material while imparting broad spectrum antimicrobial effectiveness toward 11 clinically relevant microbial species including fungi and drug resistant strains, maintaining effectiveness over a wear time duration of 7-days. OFM-Ag demonstrated significant prevention of polymicrobial biofilm formation compared to non-antimicrobial and silver-containing collagen dressing materials. Where silver-containing collagen dressing materials exhibited cytotoxic effects toward mammalian fibroblasts, OFM-Ag was determined to be non-cytotoxic, silver elution studies indicated sustained retention of silver in OFM-Ag as a possible mechanism for the attenuated cytotoxicity.ConclusionsThis work demonstrates ECM biomaterials may be functionalized with silver to favourably shift the balance between detrimental cytotoxic potential and beneficial antimicrobial effects, while preserving the ECM structure and function of utility in tissue regeneration applications.

Antimicrobial Activity of a New Aloe Vera Formulation for the Hygiene of the Periocular Area.

The aim of this study was to evaluate the antimicrobial activity of a novel preservative-free lid wipe formulation containing Aloe vera gel and hyaluronic acid that is commercialized for the hygiene of the periocular area. In vitro susceptibility testing of the solution contained in wipes against bacteria and fungi commonly colonizing the periocular area, both reference strains and multidrug-resistant (MDR) clinical isolates, was assessed following the CLSI M07-A9 and M27-A3 broth methods, respectively. The solution was 2-fold serially diluted in broth from 25 μL (25% v/v) to 0.012 μL (0.012% v/v) in microtiter plates. Plates were incubated and minimal inhibitory concentrations (MICs) were read visually. The antimicrobial effectiveness test was performed by inoculating the wipe solution with microbial suspensions at the initial concentration of 105-106 CFU/mL, as recommended by the international Pharmacopoeias. At different time intervals, samples were tested for microbial count. The MIC value of the solution ranged from 25% to 12.5% for bacteria and was 6.25% for Candida albicans. The MIC for MDR isolates was 12.5%. By assessing antimicrobial effectiveness, we found that the solution meets the criteria reported by the European Pharmacopoeia and United States Pharmacopeia for its preservative effect. This study demonstrates that the novel wipes herein tested possess antimicrobial activity against bacteria and yeast commonly found in the periocular area, and against MDR clinical isolates. The microbial death curves obtained following deliberate contamination of the wipe solution revealed potent bactericidal and fungicidal activity of the formulation.

Ethanolic Extract of Garcinia mangostana l. pericarp as Preservative in Antacid suspension

Objective. The study was conducted to determine the preservative activity of ethanolic extract of mangosteen (Garcinia mangostana L.) pericarp and its compatibility in an antacid suspension.&#x0D; Methods. The extract was subjected to phytochemical screening and was used as preservative in a formulated antacid suspension. Compatibility with the active pharmaceutical ingredient (API) and excipients were analyzed using fourier transform-infrared spectroscopy. Preservative activity of the formulation against Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa was assessed using the United States Pharmacopoeia (USP) antimicrobial effectiveness test, with methylparaben as positive control and suspension without preservative as negative control.&#x0D; Results. The extract exhibited pharmaceutical compatibility with API and excipients. The formulation revealed comparable reduction in microbial count of E. coli, S. aureus, and P. aeruginosa with positive control at Day 14 (p=0.916, 0.624, 0.335). At Day 28, comparable activity with positive control was only observed against E. coli and S. aureus (p=0.999, 0.854). However, it displayed significant increase in activity against P. aeruginosa (p=0.010) at Day 28. These activities may be attributed to glycosides and reducing substances present in the extract.&#x0D; Conclusion. The ethanolic extract from Garcinia mangostana L. pericarp acted as a preservative in the formulation of an antacid suspension. It conformed to the USP criteria for antimicrobial effectiveness test on bacteria.

Stability of extemporaneously prepared preservative-free prochlorperazine nasal spray.

The stability of an extemporaneously prepared preservative-free prochlorperazine 5-mg/mL nasal spray was evaluated. The preservative-free prochlorperazine nasal spray was prepared by adding 250 mg of prochlorperazine edisylate to 50 mL of citrate buffer in a low-density polyethylene nasal spray bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated using the major degradant prochlorperazine sulfoxide and by performing forced-degradation studies. For chemical stability studies, 3 100-μL samples of the preservative-free prochlorperazine from 5 nasal spray bottles stored at room temperature were collected at days 0, 20, 30, 45, and 60 and were assayed in triplicate using the stability-indicating HPLC method. Microbiological testing involved antimicrobial effectiveness testing based on United States Pharmacopeia (USP) chapter 51 and quantitative microbiological enumeration of aerobic bacteria, yeasts, and mold based on USP chapter 61. Samples for microbiological testing were collected at days 0, 30, and 60. The stability-indicating HPLC method clearly identified the degradation product prochlorperazine sulfoxide without interference from prochlorperazine. All tested solutions retained over 90% of the initial prochlorperazine concentration for the 60-day study period. There were no detectable changes in color, pH, and viscosity in any sample. There was no growth of bacteria, yeast, and mold for 60 days in all samples tested. An extemporaneously prepared preservative-free nasal spray solution of prochlorperazine edisylate 5 mg/mL was physically, chemically, and microbiologically stable for 60 days when stored at room temperature in low-density polyethylene bottles.

Compatibility of proton pump inhibitors in a preservative-free suspending vehicle

ObjectivesTo evaluate the microbiological and physicochemical compatibility of commonly used proton pump inhibitors (PPIs) esomeprazole, lansoprazole, omeprazole and pantoprazole compounded at a single concentration using SyrSpend SF Alka and stored...