Pharmaceutical Microbiology

Surface monitoring by using swabs forms a regular part of environmental monitoring of cleanrooms. There are different factors that affect swab recovery, from tip type to enumeration method. One factor, for swabs where the microorganisms are detached from the swab tip and which are then membrane filtered, is the period of vortex mixing. This paper discusses microbial surface sampling, and the factors that affect swab recovery. The paper presents some experimental data where vortex times are considered for a range of microorganisms. The study outcome indicates that 15 seconds vortex mixing is sufficient to obtain microbial recoveries from the swab tip above 50%.

The aim of the present study was to formulate and evaluate Metformin HCl microspheres to produce a drug delivery system with better pharmaceutical and therapeutic properties. Metformin HCl microspheres were prepared by using ethyl cellulose as a release retardant polymer by solvent evaporation method .Formulations F1, F2 and F3 were prepared using ethyl cellulose in the drug polymer ratio of 1:1, 1:2 and 1:3. A plasticizer (N-dibutyl phthalate) was added in formulations F4,F5 and F6 .The prepared microspheres were evaluated for the parameters like Percentage yield, Particle size analysis, Micromeritic properties like angle of repose, bulk density, tapped density, compressibility index, Hausner’s ratio, melting point determination, drug content estimation, microencapsulation efficiency and in vitro drug release studies. The in vitro release of Metformin HCl was slow and extended over longer period of time. As the concentration of polymer was increased, the drug release was decreased. The drug release was found to be slow in formulations F4, F5 and F6 when compared to F1, F2 and F3. Thus the study clearly indicated a promising potential of sustained release Metformin HCl microspheres containing ethyl cellulose as rate controlling polymer for effectively treating diabetes mellitus.

A novel is ligand namely 5,5'-(6-(4-methoxyphenoxy)-1,3,5-triazine-2,4-diyl)bis (azanediyl)diquinolin-8-ol (PBDQ-6)  has been prepared and characterized. This ligand was characterized by IR, 1H-NMR, and elemental analysis. Coordination polymers of this bis-ligand (NBDQ) were prepared with Cu(II), Ni(II), Co(II), Mn(II), and Zn(II) metal ions. All of these coordination polymers were characterized by elemental analyses, IR spectral and diffuse reflectance spectral studies. The thermal stability was evaluated by thermo gravimetric analyses (TGA). In addition, all of the coordination polymers have been characterized by their magnetic susceptibilities. All the novel synthesized compounds were screened for their antibacterial and antifungal activities.

Mentha piperita (Lamiaceae),the pepper mint plant is an aromatic perennial herb 50-90cm high, cultivated in most part of the world,have traditionally been used in folk medicine.A total of 130 urine samples were collected from patients examined for urinary tract infection (UTIs) using standard microbiological procedures. The collected samples were subjected to isolation on specific medium using Cysteine Lactose Electrolyte Deficient (CLED) and Saboraud dextrose agar. The purified isolates were confirmed using biochemical tests, agar well diffusion test, minimum inhibitory concentration(MIC) and minimum fungicidal concentrations (MFC) were used to assess the antifungal activity of Methanolic, n-Hexene and aqueous extract of Menthapiperita, ketoconazole was used as positive control. The results showed that highest zone of inhibition was recorded for aqueous extract followed by methanol and least zone diameter was recorded in n-Hexene extract at a range of, 21.33±1.00, 16.00±1.00 and 8.33±0.57respectively. The phytochemical screening revealed the presence of secondary metabolites such as: reducing sugar, saponins, phenols, flavonoids, alkaloids and tannins. The minimum inhibitory concentration ranged from 6.25mg/ml in methanolto n-Hexene with 3.13mg/ml. The minimum fungicidal concentrations ranged from 3.13mg/ml in methanol and aqueous 0.78mg/ml while n-Hexene at 6.25mg/ml. Mentha piperitais recommended to be used as treatment of urinary associated diseases due to its high activities shown when compared with positive control. The ability of this plant extracts to inhibit the UTI pathogens indicated its potentials to be used as alternative source of synthetic drugs

A  simple,  fast  and  accurate  method  has  been  developed  for  the  estimation of  benzene content  in  Lovastatin  by  Gas  Chromatography.  The analysis was carried out on Perkin Elmer Clarus 600 GC-HS Chromatograph. The column used was DB-624 30m X 0.32 mm X 1.8 µm fused silica analytical column (6%  cyanopropylphenyl  94 %  dimethylpolysiloxane  as  a stationary  phase).The  detector  used  was  FID  detector.

This paper provides an introduction to the sanitization and bio-decontamination of pharmaceutical facilities. Pharmaceutical facilities are made up of a series of rooms called cleanrooms. Cleanrooms are also found in many healthcare facilities. Cleanrooms and zones are typically classified according to their use (the main activity within each room or zone) and are confirmed by the cleanliness of the air by the measurement of particles. Cleanrooms are used in several industries, including the manufacture of pharmaceuticals and in the electronics industry. For pharmaceutical cleanrooms, air cleanliness is either based on EU GMP guidance for aseptically filled products, and
the EU GMP alphabetic notations are adopted; or by using the International Standard ISO14644, where numerical classes are adopted. The cleanliness of the air is controlled by an HVAC system (Heating, Ventilation and Air Conditioning).

The diversity of airborne bacteria and fungi inside and outside the T3A cephalosporin production factory was studied using different microbiological techniques. Results of indoor aeromicrobiota showed complete absence of microbial units in the environment of aseptic filling machine (class A). The counts of microbes in the aseptic filling room (class B) as well as in gowning room (class C) and in the rooms designed for preparation and filling of non-sterile cephalosporin capsules and dry mix (class D) were within the limits recommended by WHO guidelines. The count of outdoor airborne microbes using the air sampler technique was about 7-folds that of indoor air (6240 versus 854 colonies). The number of species isolated from the outdoor air was higher than that of indoor air (17 versus 10 species). Microbiological analysis of water showed much lower counts of microbes in purified water than in city water samples (80 versus 761 colonies). Microbes were also isolated from 60% of non-sterile finished products but they were completely absent in all samples of sterile finished products. The majority of microbial species recovered from the non-sterile finished products were found in both indoor and outdoor air of the cephalosporin-manufacturing factory but only four of these microbes were obtained from the purified water samples. Common microbial contaminants, namely species of Bacillus, Staphylococcus, Aspergillus, Penicillium, and Cladosporium were encountered.

Carvedilol is an antihypertensive drug use for management of Hypertension. It has the half-life of 6 hr and oral bioavailability of 25% due to first pass metabolism. The total daily dose of Carvedilol is 25 mg, hence it required frequent dosing. Transdermal patches of Carvedilol were prepared for sustained release and improve bioavailability of drug and patient compliance. Different formulations were prepared by varying the amount of HPMC-K4M and Eudragit RS-100 by solvent casting method. The prepared formulations were evaluated for various parameters like thickness, tensile strength, folding endurance, % elongation, % moisture content, % moisture uptake, % drug content, In-vitro drug release, In-vitro permeation and skin irritation study. A 32 full factorial design was applied to check the effect of varying the amount of Eudragit-RS 100 (X1) and amount of HPMC-K4M (X2) on the responses i.e. tensile strength and percentage drug released in 20 hr (Q20) as dependent variables. Regression analysis and analysis of variance were performed for dependent variables. In-vitro release data were fitted to various models to ascertain kinetic of drug release. The best selected formulation is subjected to in-vitro skin permeation and skin irritation study. Batch F7 was considered optimum batch which contained 400 mg of Eudragit RS-100 and 600 mg of HPMC-K4M, showed release 95.73% up to 24 hr and was more similar to Zero order release kinetics (r2=0.982). Batch F7 showed flux of 125.8 μg/cm2/h, hence the patch area of 1.33 cm2 would be expected to deliver targeted flux of 83.72μg/cm2/h.

A new simple, accurate, precise and reproducible Ion chromatography method has been developed for the estimation of Methane sulfonic acid in Busulfan injectable dosage. The method which is developed is also validated in complete compliance with the current regulatory guidelines by using well developed analytical method validation techniques and tools which comprises with the analytical method validation parameters like Linearity, LOD and LOQ determination, Accuracy, Method precision, Specificity, System suitability, Robustness, Ruggedness etc. by adopting the current method the linearity obtained is near to 0.999 and thus this shows that the method is capable to give a good detector response, the recovery calculated was within the range of 85% to 115% of the specification limits.

The purpose of this study was to evaluate the possibility of taste masking of Levocetirizine dihydrochloride (L-CTZ) by means of inclusion complexation and ion exchange resin. Initially an attempt was given to mask the bitter taste of the drug by inclusion complexation with β-Cyclodextrin using kneading method. But from gustatory evaluation, it was found that β-Cyclodextrin was not proven good for effective taste masking. So, another attempt was given to mask bitter taste of Levocetrizine diHCl by Kyron T-114 (weak cation exchange resin). It is a water-insoluble, high molecular weight, cross linked polymer of methacrylic acid. Kyron T-114 is inexpensive and this method is simple, rapid and cost-effective method for taste masking. Ion exchange resin complex was prepared by the batch technique and various parameters viz. resin activation, drug: resin ratio, pH, temperature, swelling time and stirring time were optimized to successfully formulate the tasteless Drug Resin Complex (DRC). Maximum drug loading was obtained when the resin was activated by acid treatment, with 1:3 drug: resin ratio, soaked in water for 90 min. and stirred with the drug for 240 minutes, pH maintained 5.5 and temperature maintained 30áµ’C. Complexation was confirmed by FT-IR and DSC study. The drug resin complex was evaluated for taste in-vitro and in-vivo evaluation. The volunteers rated the complexes as tasteless and agreeable. Drug release from DRC in salivary pH was insufficient to impart bitter taste. Complete drug release was observed at gastric 0.1 N HCl (pH 1.2). Formulation of drug resin complex was confirmed by FT-IR and DSC studies.

The objective of present study was to develop pharmaceutically elegant and stable enteric coated tablet formulation for highly unstable drug in acidic environment using pH dependent polymers. Omeprazole is a specific and non-competitive inhibitor of the enzyme H+/K+-ATPase. It is unstable in conditions of low pH and required protection from the effects of gastric acid when given orally so it is formulated in the form of enteric coated dosage forms. The core tablets were prepared by direct compression method using different concentration of crospovidone as a super disintegrant. Formulations showing less disintegration time were first subcoated with HPMC 15 cps upto 3% weight gain, followed by enteric coating with Eudragit L 100, Eudragit L 100-55 and Cellulose acetate phthalate. Pre and post compression evaluation of core and coated tablets were carried out. In vitro drug release studies were conducted in acidic and basic media to determine the appropriate coating ratio. All batches enteric coated with 8% weight gain of three polymers showed stable coating in 0.1 N HCl for 2 hours. Formulated batch F11 with 7% weight gain of Eudragit L 100-55 showed stable coating in 0.1 N HCl and had shown complete drug release in phosphate buffer pH 6.8. The prepared enteric coated tablets exhibited good physical and chemical stability, when subjected to accelerated stability studies. Further, when compared to marketed formulation (OPT tablet 20 mg Omeprazole), the prepared enteric coated tablets showed excellent similarities with marketed product (with respect to drug content, disintegration time and drug release) thereby establishing bioequivalence with marketed product.

Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity. Impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. The control of impurities is currently a critical issue to the pharmaceutical industry. International Conference on Harmonization (ICH) formulated guidelines regarding the control of impurities. Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). Identification of impurities is done by TLC, HPLC, The advent of hyphenated techniques has revolutionized impurity profiling, by not only separation but structural elucidation of impurities as well. The most exploited techniques, for impurity profiling of drugs are LC-MS-MS, LC-NMR, LC-NMR- MS, GC-MS, and LC-MS.

A straightforward, efficient and more sustainable solvent-free method has been developed for the synthesis of benzimidazole derivatives to achieve yields that were comparable to or better than, those in conventional media. It is noteworthy that the reaction was exclusively carried out in Zinc chloride catalysis system, rendering the methodology highly valuable from both environment and economic points of view. The various benzimidazoles were synthesized by the reaction of o-phenylenediamine with different types of aldehydes and characterized by their Physical constant, FT-IR Spectra, 1H NMR Spectra and LCMS. The excellent chemo selectivity, mild reaction condition, short reaction times and excellent yield made the best method then other methods.

An accurate, precise, simple and economical High Performance Liquid Chromatographic method for the Estimation of Bortezomib in its lyophilized dosage form has been developed. The method developed is Reverse Phase High Performance Liquid Chromatographic method using Hypersil BDS C18 column (Length: 150 mm, Diameter: 4.6mm, Particle size: 5μ) with a simple 0.1 % TFA buffer and Acetonitrile mixed in the proportion of 20:80v/v as a mobile phase, and Methanol: Water (90:10) as a diluent. The method so developed was validated in compliance with the regulatory guidelines by using well developed analytical method validation tool which comprises with the analytical method validation parameters like Linearity, Accuracy, Method precision, Specificity with forced degradation, System suitability, Robustness and Ruggedness. The results obtained were well within the acceptance criteria.

As described in previous work, the use of synthetic chemical ingredients in modern cosmetics is postulated to be a cause of damage to the skin microbiome. The discovery that biodiversity on the human skin is currently the only reliable indicator of skin health, meant that for the first time, a mechanism to test for healthy skin was possible. Using this mechanism and in collaboration with The Medical University of Graz, who carried out the independent study, this work aimed to help answer whether modern day synthetic cosmetics are a main cause of long-term damage to the skin microbiome. Thirty-two human participants tested three different face washes for their effect on the skin's microbial diversity, along with skin pH, moisture and TEWL (trans-epidermal water loss), washing twice-a-day for four weeks. The upper volar forearm of the volunteers was swabbed at the beginning, two weeks in and at the end of the four weeks. 16S rRNA sequencing was used. One leading 'natural' brand full of synthetic ingredients, a leading synthetic brand and a 100% natural face wash were used. Results give the first indications of a link between synthetic ingredients in a cosmetics product and its effect on skin microbiome biodiversity. It paves the way for future studies on the topic with a larger sample group, longer test period and standardised methodology to create a universal standard for testing the health of skin using benchmark diversity values. This can be used in the future to test the effectiveness of cosmetics or ingredients on skin health, leading to the restriction in cosmetics of products proven to harm the skin's natural environment. Keywords: skin microbiome; skin microbiome biodiversity; biodiversity; skin ecosystem; skin allergy epidemic; benchmark skin health values; effect of synthetic cosmetics on skin; 21st century skin ailments; measure skin health; healthy skin ecosystem; healthy skin bacteria; damaged skin bacteria

Quality by Design (QbD) refers to a holistic approach towards drug development. The purpose of research was to implement quality by design to study prospective process validation of 4 mg Salbutamol Sulphate Tablets with risk-based approach. Validation is one of the important steps in achieving and maintaining the quality of the final product. Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameters, Design Space and control strategy are identified with the help of Quality Risk Management. Three initial batches of same size, method, equipment was taken for process validation. The critical parameters involved in sifting, dry mixing, preparation of granulating solution, wet mixing, drying, sizing, lubrication, compression were identified and evaluated. The formulation properties of three initial batches of process validated tablets are compared with the marketed products of Salbutamol Sulphate Tablets (Astahlin tab and Salbetol tab). Results obtained with this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes. The output of process validation can be used to increase productivity, its consistent quality and decreasing the need for processing and market complaints.

Herbal drugs are traditional method of treating the disease in the world wide, the plant having ability to treat the disease is known as medicinal plants. Several types of medicinal plants are exists in the nature and effective in different type of disease. Peptic ulcers are a broad term that includes ulcers of digestive tract in the stomach or the duodenum. The formation of peptic ulcers depends on the presence of acid and peptic activity in gastric juice plus a breakdown in mucosal defenses. There are two major factors that can disrupt the mucosal resistance to injury: non-steroidal anti-inflammatory drugs (NSAIDs) example, aspirin and Helicobacter pylori infection. Numerous natural products have been evaluated as therapeutics for the treatment of a variety of diseases, including peptic ulcer. This article reviews the anti-acid/anti-peptic, gastro-protective and/or antiulcer properties of the most commonly employed herbal medicines. This article will be concerned only the pharmacology of that plant which shows the antiulcer and gastro-protective effects and among all the plants which one is more potent for anti-ulcer activity.

Ziziphus oenoplia Linn., Mill, is a commonly occurring thorny shrub found to have many uses such as anthelmintic, antiseptic, hepatoprotective, stomachalgia, digestive etc. It is also used in ascaris infection and healing of wounds. The plant is reported to possess alkaloids, tannins and carbohydrates. Alkaloids have also been reported to posses many biological activities like anticancer, hepatoprotective, antihelmintic etc. Therefore, this plant offers much scope to investigators on different perspectives such as Pharmacognosy, Phytochemistry and Pharmacology. The following studies highlight the botanical as well as phytochemical constituents, macroscopic, microscopic and preliminary studies of roots. These observations will help in the botanical identification and the standardization of drug in crude form and also to distinguish the drug from its adulterants. Hopefully, this little work will help to inform the people who are not aware of the plant Ziziphus oenoplia Linn., mill (Rhamnaceae) which has multi-farious beneficial properties for medicine, agriculture and husbandry.

Pharmig’s latest publication is a guide to bacterial identification. The guide discusses why identification is important and what needs to be identified, answering the often-challenging questions of ‘what’, ‘when’ and ‘how often’?

There are several text books on identification. These, however, err towards the clinical. Texts on identification approaches for pharmaceutical microbiology are not common and guidance on understanding the appropriate level of identification is difficult to obtain.

Microbial identification represents an important part of the microbiology function. This includes screening products for objectionable organisms, profiling the environmental microbiota, and investigating out-of-limits events with a view to assigning a probable point of origin. In deciding what and when (and subsequently to what level) to identify, and by the way of which methods, requires an identification strategy. This is a document each microbiology laboratory should develop.

Many parts of pharmaceutical microbiology are outlined in compendia or in guidance documents issued by regulators; included within these are the importance of bioburden assessments of intermediate and finished products, and the need to monitor the environment using standard environmental monitoring methods. What is less clear is expectation with regards to microbial identification. For identification, there are established and emerging methods, based around the microbial phenotype or genotype, yet the choice between systems is not straightforward and the selection depends, in part, on what needs to be identified. Deciding which types of samples to identify; what level of identification is appropriate (morphology, genus, or species); and what can be done with the collected information needs careful thought.

Written by Dr. Anna Lovatt (GSK) and Dr. Tim Sandle (BPL), the guide discusses different methods for phenotypic and genotypic identification, and the latest rapid methods. Troubleshooting sections and case notes are included with each section. The guide comes with a foreword from Andrew Hopkins of the MHRA.

Environmental Monitoring describes the microbiological testing undertaken in order to detect changing trends of microbial counts and micro-flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.

Aceclofenac is non-steroidal anti-inflammatory drug with marked anti-inflammatory and analgesic properties. It is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Aceclofenac is BCS class II drug with low solubility and high permeability. Micronization technique is used to increase the solubility and thus dissolution of Aceclofenac. The micronization was done using jet mill micronizer. The initial particle size of drug is 297.33 µ (D90) which was reduced to particle size 121.87 µ (D90) with single micronization, particle size 116.08 µ (D90) with double micronization and 89.23 µ (D90) with triple micronization of drug. It was observed that the solubility and thus dissolution of Aceclofenac was increased in principle media of 6.8 phosphate buffer and discriminating media 4.5 Acetate buffer with single, double and triple micronization. Thus, it can be justified that micronization is one of the good technique for enhancement of solubility of Aceclofenac by reduction of particle size of drug.

This paper reviews constructed drug delivery systems applying osmotic principles for controlled drug release from the formulation. Osmotic devices which are tablets coated with walls of controlled porosity are the most promising strategy based systems for controlled drug delivery. In contrast to common tablets, these pumps provide constant (zero order) drug release rate. When these systems are exposed to water, low levels of water soluble additive is leached from polymeric material i.e. semipermeable membrane and drug releases in a controlled manner over an extended period of time. The main clinical benefits of oral osmotic drug delivery system are their ability to improve treatment tolerability and patient compliance. These advantages are mainly driven by the capacity to deliver drugs in a sustained manner, independent of the drug chemical properties, of the patient’s physiological factors or following food intake. This review brings out the theoretical concept of drug delivery, history, advantages and disadvantages of the delivery systems, types of oral osmotic drug delivery systems, factors affecting the drug delivery system and marketed products.

Background: The bacteriological quality of household drinking water (HDW) and waterborne diseases are the main public health concerns in resource-limited countries, including Tanzania. Despite widespread use of water disinfection methods, prevalence rates of waterborne diseases like cholera, dysentery, and typhoid are still high. Objectives: This study aimed to determine bacteriological quality of HDW used by residents of Kinondoni Municipality, in Dares -Salaam, and investigate on awareness and attitude towards commonly used HDW treatment methods. Methodology: This was a cross-sectional study conducted from January to June 2016. Water samples were collected from HDW sources and subjected to presumptive coliforms count followed by Escherichia coli confirmation. Interviews were used to investigate residents" awareness and attitude towards HDW treatment and storage practices (HTSP). Results: Regression analysis predicted effects of isolated bacteria on incidences of water-borne infections. Neither types of isolated bacteria nor bacterial counts had significant associations with the prevalence of water-borne infections (p= 0.86). Prevalence of water-borne infections among household members had no associations with water storage means (p= 0.44). Combination of chemical disinfectants and filtration was the most effective water treatment methods. The most frequently isolated coliforms were Pseudomonas aeruginosa (45%) and Klebsiella (25%). Over 50% of water samples exceeded acceptable limits of coliform bacteria counts. Conclusion: High levels of coliform counts were revealed in HDW that could be attributed to poor storage and non-use of treated drinking water. Boiling of HDW killed all coliform bacteria. Satisfactory awareness of the importance of water disinfection was noted among the residents.

Rapid microbiological method technologies aim to provide more sensitive, accurate, precise, and reproducible test results when compared with conventional, growth-based methods. Rapid methods normally involve some form of automation, and the methods often capture data electronically. With several different technologies available on the marketplace, the microbiologist has a difficult, and sometimes expensive, choice to make in selecting the optimal method.

This paper, whilst addressing some of the emerging technologies, is not so much about the different rapid microbiological methods that are available; it is more concerned with the considerations that need to be considered for their selection. As such, the paper provides some advice for the microbiologist to consider when drawing up a rationale for the selection of a rapid or alternative microbiological method.

The present study was designed to analyze the various phytoconstituents present in different extracts of seeds of Calotropis gigantea. Extracts of seeds of C. gigantea were prepared in different solvents viz. methanol, chloroform, petroleum ether, di-ethyl ether and water. The screening was performed for alkaloids, anthraquinones, flavonoids, saponins, tannins, and glycosides. The color intensity or the precipitate formation was used as analytical responses to these tests. The phytochemical tests revealed the presence of alkaloids, glycosides, flavonoids, tannins, saponins, carbohydrates, fixed oils and fats.

On 15th October 2018 Tim Sandle delivered the key note address to the PDA Microbiology Europe conference. Tim Sandle has written an article which takes the form of an edited transcript of the presentation.

Whilst there is a continuing need for monitoring of the environment and conducting standardized laboratory tests, pharmaceutical microbiology has moved on to embrace:

Microbiological audits;
Rapid microbiological methods;
Conducting risk assessments, both proactive in terms of minimizing contamination and reactive, in terms of addressing microbial data deviations;
Ensuring that processes meet ‘quality by design’ principles;
And getting the microbiologist away from the bench and into the plant.

Optical spectrophotometric technologies, designed simultaneously detect the number and size of particles from a volume of air; and to additionally detect microorganisms within the air sample. Microbial detection is via a laser light source (405-nm) where the presence or absence of intrinsic fluorescence determines whether a particle is biologic or inert. By counting the microbial content of an aerosol sample on a particle-by-particle basis, the instrument provides a continuous real-time analysis of the microbial content of a given volume of air.

Process analytical technology (PAT) involves the use of different technologies and tools to build quality into the products. Effective PAT implementation comprise of science-based understanding of the physical, chemical and mechanical properties of all elements of the proposed drug product. The overall PAT venture is promising for delivering an integrated systems approach for quality design, process analysis, understanding and control, continuous improvement, knowledge and risk-based management. The incorporation of early PAT devices, increase process efficiency and safety by acting on data in real time and by eliminating sampling. PAT applications, increase detailed knowledge of processes, leading to increased robustness and greater processing opportunities. Modern developments in analytical technologies provide chemical and analytical insights for all types of chemical reactions and process monitoring such as drying, distillations, crystallizations, hydrogenations, and others.

Despite the increase in popularity of hand sanitizers (HS) in Nigeria, there is a dearth of literature on the efficacies of these products. This study assessed the efficacies of four popular brands of HS in Nigeria against some clinically important bacterial pathogens. Using the well variant of the agar dilution
method to determine antimicrobial susceptibility and the broth dilution method to determine minimum inhibitory concentration, the activities of the HS (HSF, HSM, HDT, and HSK) were evaluated against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumonia. Each of the products displayed varying activities against the test organisms. HSM had the highest inhibitory effect against all the test organisms, while HSF was the least effective. S. aureus was the most susceptible organism, with the highest susceptibility to HSM (12.0 mm). P. aeruginosa was the most resistant organism, with the highest resistance to HSM (9.0 mm). Each of the HS was bacteriostatic against all of the test bacteria and none displayed bactericidal activity. HSM and HDT reduced the mean colonyforming unit (cfu) counts of bacteria on the hands of subjects by 72% and 62%, respectively. A onetailed t-test showed that HSM was more effective than HDT in this regard. None of the products could reduce bacterial counts by 99.9%, as the manufacturers claim. Such claims need to be verified to ensure that these products contain the correct quantities of active ingredients, and sellers need to store such products according to the manufacturers’ instructions.

Multiple emulsions are also known as emulsions of emulsions, liquid membrane system or double emulsion. Multiple emulsions are polydispersed systems where both oil in water & water in oil emulsions exist simultaneously. This review focuses on preparation, characterization and potential applications of multiple emulsions. Multiple emulsions can be classified as water-in oil-in water (W/O/W) or oil-in-water-in-oil (O/W/O) emulsions. This review described five methods to prepare multiple emulsions viz. two-step emulsification method, modified two-step emulsification method, phase inversion method, membrane emulsification & micro channel emulsification method. The Multiple emulsion is characterized by average globule size & size distribution, area of interfaces, number of globules, rheological evaluation, zeta potential, percentage drug entrapment, In-vitro drug release. Multiple emulsions have been proposed to have numerous uses including their use as prolonged drug delivery system.

In this article, we will discuss the investigation of microbiological laboratory findings (a.k.a. microbiological data deviations - MDD). Two main components contributing to the difficulties of these investigations will receive special attention- the components of Time and Laboratory Error. Following this discussion and the suggested approach to be used to minimize their affects, we will discuss the investigation itself. This will be a general discussion of investigations as a concern for the QC microbiology laboratory.

The objective of this article is to review the principles underlying the development and evaluation of mucoadhesive microspheres and the research work carried out on these systems. Mucoadhesion is a topic of current interest in the design of drug delivery systems. Mucoadhesion is commonly defined as the adhesion between two materials, at least one of which is a mucosal surface. Mucoadhesive microspheres may be designed to enable a prolonged residence time at the site of application or absorption and facilitate an intimate contact with the underlying absorption surface and thus contribute to improved and/or better therapeutic performance of drugs. In recent years such mucoadhesive microspheres have been developed for oral, buccal, nasal, ocular, rectal and vaginal routes for either systemic or local effects. This review article aims to provide an overview of the various aspects of mucoadhesion, mucoadhesive materials, factors affecting mucoadhesion, evaluating methods, and various mucoadhesive drug delivery systems.

— The purpose of this present study is to determine the antibacterial potency of essential oil of Polyalthialongifolia, to determine the presence of phytochemicals and structural determination ofbioactive component from the leaf portion using GCMS. In this present study, the antibacterial activity from the essential oils of Polyalthialongifolia leaf and stem bark against seven bacteria (gram-positive and gram-negative) which are Staphylococcus aureus, Bacillussubtilis, Salmonellatyphi, Klebsiellapneumoniae, Escherichia coli, Proteus vulgaris and Pseudomonas aeruginosa known to be pathogenic to human causing high mortality among human. This study involved the extraction of essential oils from air-dried leaf and stem bark of Polyalthialongifolia using soxhlet method with n-hexane as the extracting solvent. Antibacterial activity was carried out using agar well diffusion method. Both plants part essential oil showed high antibacterial property. The sensitivity test revealed that Staphylococcus aureushas the highest zone of inhibition (18.0mm) to Polyalthialongifolia stem bark essential oil a t 100mg/ml while the least zone of inhibition (3.0mm)was recorded for Escherichia coli at 100mg/ml to the essential oil of Polyalthialongifolialeaf.However, phytochemical analysis of the plants revealed the presence of bioactive components such as cardiac glycoside, steroid, anthraquinone, flavonoid, phenol, alkaloid and reducing sugars. The presence of these components enhances the effectiveness of plants essential oil in treating various diseases and helps to act as an effective antimicrobial agent. The essential oil of Polyalthialongifolialeaf was further analyzed by gas chromatography–mass spectroscopy (GC–MS), the main constituents were 6-octadecenoic acid (30.75%), Diisooctyl phthalate (3.87%) 1,1,6-trimethyl-3-methylene (17%). The various phytochemical and GC-MS components found in this plant were responsible by and large for the antibacterial activitiesexhibited the essential oil of Polyalthialongifolia leaf and stem bark in this study.

The aim of the present work to evaluate the anticataract activity of aqueous extract of Asparagus racemosus root using in vitro model of goat lens. In the in vitro study, goat lenses were incubated in artificial aqueous humor containing 55 mM glucose (cataractogenesis) with aqueous extract of Asparagus racemosus root (AEAR) at different concentrations of 250 μg/ml and 500μg/ml at room temperature for 72 hours. Biochemical parameters studied in the lens were electrolytes (Na+, Ca+, and K+), total proteins, malondialdehyde (MDA), superoxide dismutase (SOD), glutathione (GSH) and Catalase. Photographic evaluation was also done. AEAR significantly prevented the glucose induced changes in biochemical parameters like sodium, calcium, and potassium, total proteins, MDA, SOD, GSH and Catalase. Photographic evaluation also indicated that AEAR prevented the opacity of the lens compared to model control group in vitro. These results suggest that prevention of cataract by aqueous extract of Asparagus racemosus root may be through a mechanism involving free radical scavenging, preventing lipid peroxidation and direct antioxidative capacity.