Bio-analytical method validation and its importance in pharma research - A review article

Bioanalytical method based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to give confidence in the results generated. It is the process used to establish that a quantitative analytical method is suitable for biomedical applications. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine is reliable and reproducible for the intended use. The present manuscript focuses on the consistent evaluation of the key bioanalytical validation parameters is discussed: accuracy, precision, sensitivity, selectivity, standard curve, limits of quantification, range, recovery and stability. These validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and EMA guid

Formulation and Evaluation of Gastro Retentive Mucoadhesive Sustained Release Pellets of Acyclovir

Acyclovir is an antiviral drug, belonging to the deoxyguanosine family, widely prescribed for the treatment of herpes simplex viral infections, as well as in the treatment of herpes zoster (shingles). Oral bioavailability of acyclovir is very low (10–20%) owing to its first pass metabolism with elimination half-life (t1/2) of 2-3 h. It has absorption window in upper gastrointestinal tract. Due to its rapid elimination from site of absorption and short biological half life, sustained release formulation system for acyclovir is advantageous. In this study, gastro retentive muco-adhesive SR pellets of acyclovir was prepared using HPMC K 100M as matrix former and Sodium CMC as mucoadhesive polymer by extrusion spheronization technique. Acyclovir pellets prepared with higher concentration of HPMC (batch G) showed in vitro drug release for 12 h with sufficient mucoadhesion strength and ex vivo resident time. Release kinetic studies indicated that drug release data had best fit to Higuchi’s model. In-vivo studies in rat model proved that relative bioavailability of acyclovir SR pellets get increased by 1.98 fold as compared plain drug suspension. The optimized formulation batch G was found to be stable during six months accelerated stability period

Optimization of process variables for phyllanthin extraction from Phyllanthus amarus leaves by supercritical fluid using a Box-Behnken experimental design followed by HPLC identification

The response surface methodology using the Box-Behnken design was established to describe supercritical carbon dioxide assisted extraction of phyllanthin from Phyllanthus amarus Schum and Thonn leaves prior to HPLC analysis. The effects of extraction pressure, temperature, modifier concentration and extraction time on the yield of phyllanthin were investigated. By solving the regression equation, the optimum conditions were as follows: extraction pressure 23.2 MPa, temperature 40 °C, methanol as modifier at a concentration 10 % and time 90 min. Under these conditions, the phyllanthin yield was 12.83 ± 0.28 mg g-1, which was in good agreement with the predicted values. Modifier concentration and extraction time showed a significant effect on the phyllanthin yield

Formulation and Evaluation of Gastro Retentive Mucoadhesive Sustained Release Pellets of Acyclovir

Acyclovir is an antiviral drug, belonging to the deoxyguanosine family, widely prescribed for the treatment of herpes simplex viral infections, as well as in the treatment of herpes zoster (shingles). Oral bioavailability of acyclovir is very low (10–20%) owing to its first pass metabolism with elimination half-life (t1/2) of 2-3 h. It has absorption window in upper gastrointestinal tract. Due to its rapid elimination from site of absorption and short biological half life, sustained release formulation system for acyclovir is advantageous. In this study, gastro retentive muco-adhesive SR pellets of acyclovir was prepared using HPMC K 100M as matrix former and Sodium CMC as mucoadhesive polymer by extrusion spheronization technique. Acyclovir pellets prepared with higher concentration of HPMC (batch G) showed in vitro drug release for 12 h with sufficient mucoadhesion strength and ex vivo resident time. Release kinetic studies indicated that drug release data had best fit to Higuchi’s model. In-vivo studies in rat model proved that relative bioavailability of acyclovir SR pellets get increased by 1.98 fold as compared plain drug suspension. The optimized formulation batch G was found to be stable during six months accelerated stability period

Priprava i vrednovanje biorazgradljivih implantata s kontroliranim oslobađanjem za postoperativnu primjenu

Biodegradable implants of ciprofloxacin hydrochloride for post operative site delivery were prepared using glyceryl monostearate and different concentrations of polyethylene glycol (PEG 6000) glycerol and Tween 80 as erosion enhancers by compression and molding technique. Formulations were subjected to in vitro drug release by the USP dissolution method, while promising formulations were subjected to in vitro drug release by the agar gel method and also to stability studies. It was observed that glyceryl monostearate formed hydrophobic matrix and delayed the drug delivery. Antibiotic release profile was controlled by using different combinations of erosion enhancers. The formulation prepared by compression method showed more delayed release as compared to formulations prepared by molding method.Biorazgradljivi implantati ciprofloksacin hidroklorida za postoperativnu primjenu pripravljeni su pomoću gliceril monostearata (GMS) i različitih koncentracija polietilen glikola (PEG 6000), glicerola i Tween 80 kao promotora erozije metodom kompresije i lijevanja. Oslobađanje ljekovite tvari iz pripravaka praćeno je in vitro prema USP metodi. Pripravci koji su dali dobre rezultate ispitani su i in vitro metodom s agarom te su podvrgnuti testovima stabilnosti. Primijećeno je da gliceril monostearat tvori hidrofobni matriks i usporava oslobađanje lijeka. Koristeći različite kombinacije promotora erozije postignuto je kontrolirano oslobađanje antibiotika. Oslobađanje iz implantata dobivenih metodom kompresije sporije je od implantata dobivenih metodom lijevanja

FABRICATION AND EVALUATION OF HERBAL OINTMENT FORMULATIONS OF MORINGA OLEIFERA FOR TOPICAL DELIVERY

Objective: Traditional medicine is an important source of potentially useful new compounds for the development of chemotherapeutic agents. Moringa oleifera Lam. is a multipurpose and exceptionally nutritious vegetable tree with a variety of potential uses. It is distributed in many countries of the tropics and subtropics. Ointments are semisolid systems which behave as viscoelastic materials when shear stress is applied. They contain medicaments and are intended to be applied externally to the body or to the mucous membrane. Methods: In present study the Morenga oleifera leaves extract was used to formulate four different ointment formulations with different bases like cetostearyl alcohol, hard paraffin, and liquid paraffin. Formulations were evaluated for different parameters such as general appearance, spreadability, pH, extrudability, centrifugation,   irritancy, loss on drying, stability study etc. Results: All formulations were found to be free of grittiness, homogeneous, without phase separation with green colour with a smooth homogeneous texture and glossy appearance. Viscosity of the ointment formulations was in the range of 32.21±0.51 to 35.3±0.4. Formulations were found to be stable at different temperature. Conclusion: On the basis of results it can be concluded that ointment preparations with extract of Morenga oleifera leaves indicated the suitability of method for the production of ointments. Peer Review History: Received 13 June 2018;   Revised 27 August; Accepted 1 September, Available online 15 September 2018 UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. Received file:        Reviewer's Comments: Average Peer review marks at initial stage: 3.5/10 Average Peer review marks at publication stage: 7.5/10 Reviewer(s) detail: Dr. Jennifer Audu-Peter, University of Jos, Nigeria, [email protected] Dr. Emmanuel O. Olorunsola, Department of Pharmaceutics & Pharmaceutical Technology, University of Uyo, Nigeria, [email protected] Similar Articles: A RECENT OVERVIEW OF LOCALLY ADMINISTERED TOPICAL OTIC DOSAGE FORM

Evaluation of 3-(3-chloro-phenyl)-5-(4-pyridyl)-4,5-dihydroisoxazole as a Novel Anti-Inflammatory Drug Candidate

BACKGROUND: 3-(3-chloro-phenyl)-5-(4-pyridyl)-4,5-dihydroisoxazole (DIC) is a five-membered heterocyclic compound containing a N-O bond. The anti-inflammatory effects of this compound were studied both in vitro and in vivo. PRINCIPAL FINDINGS: DIC effectively decreased TNF-α and IL-6 release from LPS-stimulated macrophages in a dose dependent manner. DIC diminished the levels of COX-2 with subsequent inhibition of PGE(2) production. DIC also compromised HMGB1 translocation from the nucleus to the cytoplasm. Moreover, DIC prevented the nuclear translocation of NF-κB and inhibited the MAPK pathway. In vivo, DIC inhibited migration of neutrophils to the peritoneal cavity of mice. CONCLUSIONS: This study presents the potential utilization of a synthetic compound, as a lead for the development of novel anti-inflammatory drugs

The COVID-19 pandemic and its global effects on dental practice : An International survey

Objectives: A multicentre survey was designed to evaluate the impact of COVID-19 outbreak on dental practice worldwide, estimate the COVID-19 related symptoms/signs, work attitudes and behaviour and the routine use of protective measures and Personal Protective Equipment (PPE). Methods: A global survey using a standardized questionnaire with research groups from 36 countries was designed. The questionnaire was developed and pretested during April 2020 and contained three domains: 1) Personal data; 2) COVID-19 positive rate and symptoms/signs presumably related to the coronavirus; 3) Working conditions and PPE adopted after the outbreak. Countries' data were grouped by the Country Positive Rate (CPR) during the survey period and by Gross-National-Income per capita. An ordinal multinomial logistic regression model was carried out with COVID-19 self-reported rate referred by dental professionals as dependent variable to assess the association with questionnaire items. Results: A total of 52,491 questionnaires were returned with a male/female ratio of 0.63. Out of the total respondents, 7,859 dental professionals (15%) reported symptoms/signs compatible with COVID-19. More than half of the sample (n = 27,818; 53%) stated to use FFP2/N95 masks, while 21,558 (41.07%) used eye protection. In the bivariate analysis, CPR and N95/FFP2 were significantly associated (OR = 1.80 95% =5.20 95% 95% CI = 1.60/2.82 and OR CI = 1.44/18.80, respectively), while Gross-National-Income was not statistically associated with CPR (OR = 1.09 CI = 0.97/1.60). The same significant associations were observed in the multivariate analysis. Conclusions: Oral health service provision has not been significantly affected by COVID-19, although access to routine dental care was reduced due to country-specific temporary lockdown periods. While the dental profession has been identified at high-risk, the reported rates of COVID-19 for dental professionals were not significantly different to those reported for the general population in each country. These findings may help to better plan oral health care for future pandemic events

Association of cord blood methylation fractions at imprinted insulin-like growth factor 2 (IGF2), plasma IGF2, and birth weight

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The COVID-19 pandemic and its global effects on dental practice. An international survey

Objectives A multicentre survey was designed to evaluate the impact of COVID-19 outbreak on dental practice worldwide, estimate the COVID-19 related symptoms/signs, work attitudes and behaviour and the routine use of protective measures and personal protective equipment (PPE). Methods A global survey using a standardized questionnaire with research groups from 36 countries was designed. The questionnaire was developed and pretested during April 2020 and contained three domains: 1) personal data; 2) COVID-19 positive rate and symptoms/signs presumably related to the coronavirus; 3) working conditions and PPE adopted after the outbreak. Countries’ data were grouped by the country positive rate (CPR) during the survey period and by Gross-National-Income per capita. An ordinal multinomial logistic regression model was carried out with COVID-19 self-reported rate referred by dental professionals as dependent variable to assess the association with questionnaire items. Results A total of 52,491 questionnaires were returned with a male/female ratio of 0.63. Out of the total respondents, 7,859 dental professionals (15%) reported symptoms/signs compatible with COVID-19. More than half of the sample (n=27,818; 53%) stated to use FFP2/N95 masks, while 21,558 (41.07%) used eye protection. In the bivariate analysis, CPR and N95/FFP2 were significantly associated (OR=1.80 95%CI=1.60/2.82 and OR=5.20 95%CI=1.44/18.80, respectively), while Gross-National-Income was not statistically associated with CPR (OR=1.09 95%CI=0.97/1.60). The same significant associations were observed in the multivariate analysis. Conclusions Oral health service provision has not been significantly affected by COVID-19, although access to routine dental care was reduced due to country-specific temporary lockdown periods. While the dental profession has been identified at high-risk, the reported rates of COVID-19 for dental professionals were not significantly different to those reported for the general population in each country. These findings may help to better plan oral health care for future pandemic events