scholarly journals A Drug Content, Stability Analysis, and Qualitative Assessment of Pharmacists’ Opinions of Two Exemplar Extemporaneous Formulations

Molecules ◽  
2020 ◽  
Vol 25 (13) ◽  
pp. 3078
Author(s):  
Melissa Kirkby ◽  
Kurtis Moffatt ◽  
Aoife M. Rogers ◽  
Paul J. McCague ◽  
James C. McElnay ◽  
...  
Keyword(s):  
Particle Size ◽  
Antimicrobial Properties ◽  
Qualitative Assessment ◽  
High Confidence ◽  
Pharmaceutical Ingredients ◽  
Drug Content ◽  
Extemporaneous Preparation ◽  
Perceived Complexity ◽  
Self Administered Questionnaire ◽  
Insight Into

Despite a decline in the number of active pharmaceutical ingredients prepared extemporaneously using proprietary products, there remains a need for such products in the community (for example, liquid medicines for paediatrics which may be otherwise commercially unavailable). A lack of experience and quality assurance systems may have diminished pharmacist’s confidence in the extemporaneous preparation process; therefore, pharmacists were asked to prepare two proprietary products, omeprazole and amlodipine. The resulting products were characterised in terms of variability in drug quantity, stability, particle size and antimicrobial properties. Furthermore, a self-administered questionnaire was used to assess 10 pharmacists’ opinions on the perceived complexity of the extemporaneous compounding process and their overall confidence in the final extemporaneously compounded products. Drug content studies revealed that 88.5% and 98.0% of the desired drug content was obtained for omeprazole and amlodipine, respectively. Antimicrobial properties were maintained for both drugs, however variability in particle size, particularly for amlodipine, was evident between formulations. While pharmacists who partook in the study had some or high confidence in the final products, they reported difficulty formulating the suspensions. Findings from this study provide insight into pharmacists’ views on two extemporaneously prepared products and highlight the variability obtained in preparations prepared by different pharmacists.

Azithromycin nanosuspension preparation using evaporative precipitation into aqueous solution (EPAS) method and its comparative dissolution study

2020 ◽  
Vol 17 ◽  
Author(s):  
Mohammad Hossain Shariare ◽  
Tonmoy Kumar Mondal ◽  
Hani Alothaid ◽  
Md. Didaruzzaman Sohel ◽  
MD Wadud ◽  
...  
Keyword(s):  
Aqueous Solution ◽  
Particle Size ◽  
Dissolution Rate ◽  
Average Particle Size ◽  
Scale Up ◽  
Average Particle ◽  
Total Drug ◽  
Residual Solvent ◽  
Dissolution Study ◽  
Drug Content

Aim: EPAS (evaporative precipitation into aqueous solution) was used in the current studies to prepare azithromycin nanosuspensions and investigate the physicochemical characteristics for the nanosuspension batches with the aim of enhancing the dissolution rate of the nanopreparation to improve bioavailability. Methods: EPAS method used in this study for preparing azithromycin nanosuspension was achieved through developing an in-house instrumentation method. Particle size distribution was measured using Zetasizer Nano S without sample dilution. Dissolved azithromycin nanosuspensions were also compared with raw azithromycin powder and commercially available products. Total drug content of nanosuspension batches were measured using an Ultra-Performance Liquid Chromatography (UPLC) system with Photodiode Array (PDA) detector while residual solvent was measured using gas chromatography (GC). Results: The average particle size of azithromycin nanosuspension was 447.2 nm and total drug content was measured to be 97.81% upon recovery. Dissolution study data showed significant increase in dissolution rate for nanosuspension batch when compared to raw azithromycin and commercial version (microsuspension). The residual solvent found for azithromycin nanosuspension is 0.000098023 mg/ mL or 98.023 ppb. Conclusion: EPAS was successfully used to prepare azithromycin nanoparticles that exhibited significantly enhanced dissolution rate. Further studies are required to scale up the process and determine long term stability of the nanoparticles.

Preparation of Ginger Oil in Water Nanoemulsion Using Phase Inversion Composition Technique: Effects of Stirring and Water Addition Rates on their Physico-Chemical Properties and Stability

2019 ◽  
Vol 0 (0) ◽  
Author(s):  
Ashraf Farshbaf-Sadigh ◽  
Hoda Jafarizadeh-Malmiri ◽  
Navideh Anarjan ◽  
Yahya Najian
Keyword(s):  
Particle Size ◽  
Phase Inversion ◽  
Antimicrobial Properties ◽  
Chemical Properties ◽  
Water Addition ◽  
Chromatography Method ◽  
Stirring Rate ◽  
Physico Chemical ◽  
Oil In Water ◽  
Addition Rate

Abstract Ginger oil in water (O/W) nanoemulsions, were produced using phase inversion composition method and Tween 80, as emulsifier. Effects of processing parameters namely, stirring rate (100 to1000 rpm) and water addition rate (1–10 mL/min) were evaluated on the physico-chemical, morphological, antioxidant and antimicrobial properties of the prepared O/W nanoemulsions using response surface methodology (RSM). Results indicated that well dispersed and spherical ginger nanodroplets were formed in the nanoemulsions with minimum particle size (8.80 nm) and polydispersity index (PDI, 0.285) and maximum zeta potential value (−9.15 mV), using stirring rate and water addition rate of 736 rpm and 8.18 mL/min, respectively. Insignificant differences between predicted and experimental values of the response variables, indicated suitability of fitted models using RSM. Mean particle size of the prepared nanoemulsion using optimum conditions were changed from 8.81 ± 1 to 9.80 ± 1 nm, during 4 weeks of storage, which revealed high stability of the resulted ginger O/W nanoemulsion. High antioxidant activity (55.4%), bactericidal (against Streptococcus mutans) and fungicidal (against Aspergillus niger) activities of the prepared nanoemulsion could be related to the presence of gingerols and shogaols, a group of phenolic alkanones, in the ginger oil, which those were detected by gas chromatography method.

The carmine dilemma: does the natural colourant preference outweigh nausea?

2018 ◽  
Vol 120 (8) ◽  
pp. 1915-1928
Author(s):  
Judith Müller-Maatsch ◽  
Johannes Jasny ◽  
Katharina Henn ◽  
Claudia Gras ◽  
Reinhold Carle
Keyword(s):  
Design Methodology ◽  
Consumer Perception ◽  
Natural Food ◽  
German Population ◽  
Misleading Information ◽  
Content Type ◽  
Broad Cross Section ◽  
First Time ◽  
Self Administered Questionnaire ◽  
Insight Into

Purpose The purpose of this paper is to provide insight into the consumers’ perception of natural and artificial food colourants. Furthermore, attitudes towards the application of carmine, being technically important and ubiquitously used to impart red shades, are assessed and analysed. Originating from insects, carmine is considered as natural but may arouse disgust. Design/methodology/approach In total, 625 individuals were surveyed using an online, self-administered questionnaire to represent a broad cross-section of the German population. Findings Independent of their origin, the application of colourants was rejected by 57.0 per cent of the interviewees. In total, 31.8 per cent of the participants stated a neutral attitude, while only 11.2 per cent expressed a positive notion. Most respondents preferred colourants from natural sources to artificial ones. While consumers perceive natural food colourants composed of genuine plant pigments positively, 61.6 per cent of respondents disliked the application of animal-derived colourants, 24.8 per cent of them did neither reject nor like it, and only 13.6 per cent of the interviewees stated a positive attitude towards them. The findings of this paper further indicate consumers’ preference for colourants to be either artificial or plant-derived rather than carmine. Food colourants are being rejected, possibly due to misleading information and confusing labelling. Consequently, information about carmine, including its origin and production, did not increase the aversion to products that are dyed with it, but increased their acceptance. Originality/value This study outlines consumer perception and attitudes towards food colourants. For the first time, the findings of this paper report the effect of revealing information about an additive, which initially aroused disgust, and its influence on consumer perception.

scholarly journals EVALUATION OF STABILITY OF ROPINIROLE HYDROCHLORIDE AND PRAMIPEXOLE DIHYDROCHLORIDE MICROSPHERES AT ACCELERATED CONDITION

2018 ◽  
Vol 10 (4) ◽  
pp. 82
Author(s):  
Koyel Kar ◽  
R. N. Pal ◽  
Gouranga Nandi
Keyword(s):  
Particle Size ◽  
Drug Release ◽  
Surface Morphology ◽  
Shelf Life ◽  
Stability Study ◽  
In Vitro Drug Release ◽  
Drug Content ◽  
Ropinirole Hydrochloride ◽  
Pramipexole Dihydrochloride

Objective: The objective of the present work was to conduct accelerated stability study as per international council for harmonisation (ICH) guidelines and to establish shelf life of controlled release dosage form of ropinirole hydrochloride and pramipexole dihydrochloride microspheres for a period of 6 mo.Methods: Most optimized batch of ropinirole hydrochloride and pramipexole dihydrochloride (F12 and M12 respectively) were selected and subjected to exhaustive stability testing by keeping the sample in stability oven for a period of 3 and 6 mo. Various parameters like surface morphology, particle size, drug content, in vitro drug release and shelf life were evaluated at 3 and 6 mo period. The surface morphology of the formulated microspheres was determined by scanning electron microscopy (SEM). The particle size of the microspheres was estimated by optical microscopy method. The drug content was assayed by the help of ultra-violet spectrophotometer (UV). The in vitro drug release was performed by using Paddle II type dissolution apparatus and the filtrate was analyzed by UV spectrophotometer. The shelf life of the optimized microspheres was calculated by using the rate constant value of the zero-order reaction.Results: A minor change was recorded in average particle size of F12 and M12 microspheres after storage for 6 mo. For F12 and M12, initially the particle size was 130.00 µm and 128.92 µm respectively and after 6 mo it was found to be 130.92 µm and 128.99 µm respectively. There was no change in surface morphology of F12 and M12 microspheres after 6 mo of storage. The shape of microspheres remained spherical and smooth after 6 mo. An insignificant difference of drug content was recorded after 6 mo compared to the freshly prepared formulation. For F12 and M12, 94.50% and 93.77% of the drug was present initially and after 6 mo 94.45% and 93.72% of the drug was recorded. In vitro drug release was recorded after 6 mo for F12 and M12. Initially, 97.99% and 97.69% of the drug was released till 14th hour respectively for F12 and M12. After 6 mo, 98.23% and 97.99% of the drug was released respectively. The percentage residual drug content revealed that the degradation of microspheres was low. Considering the initial percentage residual drug content as 100%, 99.94% of the drug was recorded for both F12 and M12. The shelf life for F12 and M12 was found to be 10 y 52 d and 10 y 70 d respectively which were determined by the zero-order kinetic equation.Conclusion: A more or less similar surface morphology, particle size, drug content and percent of drug release before and after stability study confirmed the stability of F12 and M12 microspheres after storage for 6 mo and prove the efficacy of the microspheres in the site-specific delivery of drugs in Parkinson’s disease.

FORMULATION AND EVALUATION OF NATEGLINIDE NANOSPONGES

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (02) ◽  
pp. 27-35
Author(s):  
A. A Bakliwal ◽  
◽  
D. S. Jat ◽  
S. G. Talele ◽  
A. G. Jadhav
Keyword(s):  
Particle Size ◽  
Drug Release ◽  
Release Kinetics ◽  
Synthesis Method ◽  
Ultra Sound ◽  
Size Analysis ◽  
Release Kinetic ◽  
In Vitro Drug Release ◽  
Drug Content

The objective of the present study was to produce extended release nateglinide nanosponges for oral delivery. Preparation of nanosponges leads to solubility enhancement. Nateglinide is a BCS Class II drug, having low solubility. So, to increase the solubility of nateglinide it is formulated into nanosponges. Nanosponges using ethyl cellulose as a polymer and dichloromethane as a cross-linker were prepared successfully by ultra-sound assisted synthesis method. The effects of different drug: placebo ratios on the physical characteristics of the nanosponges as well as the drug content and in vitro drug release of the nanosponges were investigated. Particle size analysis and surface morphology of nanosponges were performed. The scanning and transmission electron microscopy of nanosponges showed that they were spongy in nature. The particle size was found to be in the range 46.37 - 97.23 nm out of which particle size of the optimized formulation was 51.79 nm and the drug content was found to 79.43 %. The optimized nanosponge formulations were selected for preparing nanosponge tablets for extended drug delivery by oral route. These tablets were prepared using xanthan gum and PVP K-30 and were evaluated by pre-compression and post-compression parameters. The nateglinide nanosponges tablet formulation were studied for different parameters using Design Expert Software. All formulations were evaluated for in vitro drug release analyzed according to various release kinetic models and it was found that it follows zero order release kinetics.

Quality Management

2014 ◽  
pp. 1547-1570
Author(s):  
Alessandra Vecchi ◽  
Louis Brennan
Keyword(s):  
Quality Management ◽  
Best Practice ◽  
Global Leadership ◽  
Manufacturing Strategy ◽  
Organizational Behaviour ◽  
Comprehensive Management ◽  
Quality Practices ◽  
National Boundaries ◽  
Self Administered Questionnaire ◽  
Insight Into

The purpose of this chapter is to address the extent to which quality management is “culture-specific.” The chapter presents the results of a survey administered across 21 countries that seeks to examine quality priorities and practices by adopting the Global Leadership and Organizational Behaviour Effectiveness (GLOBE) framework (House et al., 2004). Drawing on previous research (Vecchi & Brennan, 2011), data was collected in 2009 as part of the fifth iteration of the International Manufacturing Strategy Survey (IMSS). The methodology involved the use of a self-administered questionnaire to director/head of operations/manufacturing in best practice firms within the sector of firms classified by ISIC codes (rev.3.1) Divisions 28-35. From this study, it emerges that adopting the GLOBE framework provides an invaluable insight into understanding quality management across countries. While some previous research portrays quality management as a comprehensive management paradigm with elements and relationships that transcend cultural and national boundaries, the current study provides evidence that the adoption of certain quality practices across different countries can follow distinctive patterns.

scholarly journals Design Space Identification and Visualization for Continuous Pharmaceutical Manufacturing

Pharmaceutics ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 235 ◽  
Author(s):  
Samir Diab ◽  
Dimitrios I. Gerogiorgis
Keyword(s):  
Design Space ◽  
Flow Chemistry ◽  
Pharmaceutical Manufacturing ◽  
Design And Optimization ◽  
Pharmaceutical Ingredients ◽  
Continuous Pharmaceutical Manufacturing ◽  
Continuous Flow Chemistry ◽  
Material Usage ◽  
Novel Processing ◽  
Insight Into

Progress in continuous flow chemistry over the past two decades has facilitated significant developments in the flow synthesis of a wide variety of Active Pharmaceutical Ingredients (APIs), the foundation of Continuous Pharmaceutical Manufacturing (CPM), which has gained interest for its potential to reduce material usage, energy and costs and the ability to access novel processing windows that would be otherwise hazardous if operated via traditional batch techniques. Design space investigation of manufacturing processes is a useful task in elucidating attainable regions of process performance and product quality attributes that can allow insight into process design and optimization prior to costly experimental campaigns and pilot plant studies. This study discusses recent demonstrations from the literature on design space investigation and visualization for continuous API production and highlights attainable regions of recoveries, material efficiencies, flowsheet complexity and cost components for upstream (reaction + separation) via modeling, simulation and nonlinear optimization, providing insight into optimal CPM operation.

Characterization of Electrophoretic Lipoprotein Fractions: Immunochemical and Electron Microscopic Studies

1972 ◽  
Vol 18 (6) ◽  
pp. 534-538
Author(s):  
Mario Werner ◽  
Albert L Jones
Keyword(s):  
Electron Microscopy ◽  
Particle Size ◽  
Electrophoretic Pattern ◽  
Electron Microscopic ◽  
Lipoprotein Subfractions ◽  
New Techniques ◽  
Microscopic Studies ◽  
Insight Into

Abstract To improve the characterization of electrophoretic lipoprotein subfractions, we developed two new techniques for analyzing lipoproteins after electrophoresis on thin agarose layers. Overlay with antisera exactly localizes specific apoproteins without any distortion caused by antigen diffusion; electron microscopy of eluted fractions determines the varying particle-size distribution. Applied together, these methods can detect individual differences between hyperlipemic samples that are not immediately apparent in the electrophoretic pattern, and should provide valuable new insight into the classification of hyperlipoproteinemias.

scholarly journals FORMULATION OF POLYMERIC NANOSUSPENSION CONTAINING PRAMIPEXOLE DIHYDROCHLORIDE AND HESPERIDIN FOR IMPROVED TREATMENT OF PARKINSON’S DISEASES

2018 ◽  
Vol 11 ◽  
Author(s):  
Somasundaram I
Keyword(s):  
Particle Size ◽  
Drug Release ◽  
Zeta Potential ◽  
In Vitro Release ◽  
Entrapment Efficiency ◽  
Burst Release ◽  
Drug Content ◽  
Pramipexole Dihydrochloride ◽  
Vitro Release

Aims and Objectives: The present study is to formulate the nanosuspension containing a hydrophilic drug pramipexole dihydrochloride and hesperidin and to increase the drug entrapment efficiency.Methods: Hesperidin and pramipexole dihydrochloride loaded in chitosan nanosuspension is prepared by ionic gelation method using chitosan and tripolyphosphate. There was no incompatibility observed between the drug and polymer through Fourier transform infrared and differential scanning calorimetric. Various other parameters such as particle size, zeta potential, scanning electron microscope, drug content, drug entrapment efficiency, and in vitro release have been utilized for the characterization of nanoparticles.Results and Discussion: The average size of particle is 188 nm; zeta potential is 46.7 mV; drug content of 0.364±0.25 mg/ml; entrapment efficiency of 72.8% is obtained with HPN3 formulation. The PHC1 shows the highest drug release followed by PHC2 due to low concentration of polymer and PHC4 and PHC5 show less drug release due to high concentration of polymer. The in vitro release of PHC3 is 85.2%, initial the burst release is shown which is approximately 60% in 8 h; then, slow release later on drastic reduction in release rate is shown in 24 h. The in vivo study histopathological report confers the effective protective against rotenone induces Parkinson’s.Conclusion: PHC3 was chosen as the best formulation due to its reduced particle size and controlled release at optimum polymer concentration which may be used to treat Parkinson’s disease effectively..

scholarly journals Chitosan/Essential Oils Formulations for Potential Use as Wound Dressing: Physical and Antimicrobial Properties

Materials ◽  
2019 ◽  
Vol 12 (14) ◽  
pp. 2223 ◽  
Author(s):  
Elaine Pereira dos Santos ◽  
Pedro Henrique Medeiros Nicácio ◽  
Francivandi Coêlho Barbosa ◽  
Henrique Nunes da Silva ◽  
André Luís Simões Andrade ◽  
...  
Keyword(s):  
Essential Oil ◽  
Antimicrobial Properties ◽  
Wound Dressings ◽  
Qualitative Assessment ◽  
Diffusion Method ◽  
Mechanical Resistance ◽  
Film Forming ◽  
Good Transparency ◽  
The Impact

Film-forming emulsions and films, prepared by incorporating different concentrations of clove essential oil (CEO) and melaleuca essential oil (MEO) into chitosan (CS) were obtained and their properties were evaluated. Film-forming emulsions were characterized in terms of qualitative assessment, hydrogen potential and in vitro antibacterial activity, that was carried by the agar diffusion method, and the growth inhibition effects were tested on the Gram-positive microorganism of Staphylococcus aureus, Gram-negative microorganisms of Escherichia coli, and against isolated fungi such as Candida albicans. In order to study the impact of the incorporation of CEO and MEO into the CS matrix, the appearance and thickness of the films were evaluated. Furthermore, Fourier transform infrared spectroscopy (FTIR), contact angle measurements, a swelling test, scanning electron microscopy and a tensile test were carried out. Results showed that the film-forming emulsions had translucent aspect with cloudy milky appearance and showed antimicrobial properties. The CEO had the highest inhibition against the three strains studied. As regards the films’ properties, the coloration of the films was affected by the type and concentration of bioactive used. The chitosan/CEO films showed an intense yellowish coloration while the chitosan/MEO films presented a slightly yellowish coloration, but in general, all chitosan/EOs films presented good transparency in visible light besides flexibility, mechanical resistance when touched, smaller thicknesses than the dermis and higher wettability than chitosan films, in both distilled water and phosphate-buffered saline (PBS). The interactions between the chitosan and EOs were confirmed by. The chitosan/EOs films presented morphologies with rough appearance and with EOs droplets in varying shapes and sizes, well distributed along the surface of the films, and the tensile properties were compatible to be applied as wound dressings. These results revealed that the CEO and MEO have a good potential to be incorporated into chitosan to make films for wound-healing applications.

Sign in / Sign up

Export Citation Format

Share Document