AN OVERVIEW OF ANALYTICAL METHOD VALIDATION

In line with the developments in the pharmaceutical field, the product range is constantly being renewed and diversified. New analytical techniques need to be developed and validated for new pharmaceutical products. The validation of an improved method is an internationally recognized scientific requirement, as these validation practices are also indicative of the competence of the analytical laboratory. The method development is a process that ensures the applicability and reliability of the data. The result is a more comprehensive understanding of the standard test methods and a further insight into the connection between test methodology and product quality. It is important to validate an advanced method. Because if the method can not be reproduced, the method is meaningless. Validation is  a continuous balance among costs, risks and technical possibilities.                         Peer Review History: Received 5 February 2020;   Revised 22 February; Accepted 1 March, Available online 15 March 2020 Academic Editor: Dr. Asia Selman Abdullah, Al-Razi university, Department of Pharmacy, Yemen, [email protected] 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: 6.0/10 Average Peer review marks at publication stage: 7.5/10 Reviewer(s) detail: Kian Navaee, Shahre Daru Pharmaceutical Co., Iran, [email protected] Dr. Mohammad Shaheen Khan, University Malaysia Sabah, Malaysia, [email protected] Similar Articles: ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF OMEPRAZOLE AND ASPIRIN USING REVERSE PHASE HPLC METHOD IN BULK AND DOSAGE FORM VALIDATION OF HPLC AND UV VISIBLE METHODS FOR FEW SELECTED BLOOD PRESSURE LOWERING DRUGS AND THEIR FORMULATION

USAGE OF 3D PRINTER TECHNOLOGY IN MEDICAL AND PHARMACEUTICAL FIELDS: A REVIEW

Along with the developing technology, 3D printers have found broad applications in medical and pharmaceutical fields. Precise digital control over layer by layerprinting given by 3D printers allows drugs, cosmetics and medical devices like prostheses to be personalized for treatment. Additionaly, the physical structure of 3D printed productsand theirvisualization is effective on surgical planning, educational and research applications alleviating the endeavior of surgeons,students and scientists, respectively. Since FDA’s first 3D printed drug approval in 2015, the research for new approaches has been growing although the manufacturers need regularity certainty. However this technology exists for a long time and  it is of public interest now due to the approval of 3-D printed tablet and other medical devices and also with the advent of USFDA’s guidance on  technical considerations specific to devices using additive manufacturing which encompasses 3-dimensional (3D) printing has triggered many thoughts about this technology which needs to be considered for successful delivery of intended product.  As for 3D organ printing, it remains the great expectation albeit some attempts. This review is aimed at giving brief explanations about 3D printing achievements and applications in medical and pharmaceutical fields.                 Peer Review History: Received 4 June 2019;   Revised 11 July; Accepted 16 July, Available online 17 July 2019 Academic Editor: Rola Jadallah, Arab American University, Palestine, [email protected] 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 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: 5.5/10 Average Peer review marks at publication stage: 7.5/10 Reviewer(s) detail: Prof. Dr. Amani S. Awaad, Prince Sattam Bin Abdulaziz University, Al-Kharj. KSA., [email protected] Dr. George Zhu, Tehran University of Medical Sciences, Tehran, Iran, [email protected]

A RECENT OVERVIEW OF LOCALLY ADMINISTERED TOPICAL OTIC DOSAGE FORMS

Ear diseases can significantly affect the life quality of patient, so the need for effective treatment encourages the development of new active substances and new dosage forms. Otic dosage forms may be solutions, suspensions, or emulsions of drops or spray for washing the ear or for administration to the ear canal. They may be ear-wash preparations in the form of solution or emulsion, or medicated semi-solid or solid preparations in the form of gel, cream, ointment, powders, sticks or buffers. These preparations can contain one or much more active ingredients in a suitable vehicle and additionally may contain different excipients for isotonisation, pH adjustment, viscosity or solubility enhancement, buffering, preservation, etc. These excipients should not alter the pharmacological effect of active substances and should not be toxic or irritating. Ear preparations can be packaged in single or multiple doses. It is anticipated that otic dosage forms will be improved and the importance of locally applied, safe and highly controlled drug delivery systems will increase in the future.                    Peer Review History: Received 4 August 2019;   Revised 21 August; Accepted 9 September, Available online 15 September 2019 Academic Editor: Dr. Ali Abdullah Al-yahawi, Al-Razi university, Department of Pharmacy, Yemen, [email protected] 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 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: 5/10 Average Peer review marks at publication stage: 8/10 Reviewer(s) detail: Dr. Iman Muhammad Higazy, National Research Center, Egypt, [email protected] Dr. George Zhu, Tehran University of Medical Sciences, Tehran, Iran, [email protected] Similar Articles: DEVELOPMENT AND ESTIMATION OF ANTI-INFLAMMATORY ACTIVITY OF TOPICAL ETORICOXIB EMULGEL BY CARRAGEENAN INDUCED PAW OEDEMA METHO

Preparıng a new bıosensor for glucose determınatıon by ımmobılızatıon of glucose oxıdase ın polyanılıne-polyvınylsulphonate fılm

Bu çalısmada, glukoz tayini için yeni bir amperometrik biyosensör gelistirildi. Bu amaçla, platin levha üzerinde anilinin polivinilsülfonat, potasyum ferrisiyanür ve metilen mavili ortamda elektropolimerlesmesi ile polianilin-polivinilsülfonat-ferrisiyanür ve polianilin-polivinilsülfonatmetilen mavisi filmleri hazırlandı ve özellikleri birbirleriyle karsılastırıldı. Polianilin-polivinilsülfonat-ferrisiyanür filminin optimum çalısma sartları belirlendi. Glukoz oksidaz enzimi, polianilin-polivinilsülfonatferrisiyanür film içine hapsetme yöntemiyle immobilize edildi. Glukoz tayini, hazırlanan enzim elektrodun yüzeyinde gerçeklesen enzimatik tepkime sonucu olusan hidrojen peroksitin ve ferrisiyanür medyatörünün indirgenmis halinin 0,30 V'da yükseltgenmesine dayanarak yapıldı. Biyosensörün glukoz tayini için çalısma aralığı tayin edildi. Glukoz biyosensörünün cevabına pH'nın ve sıcaklığın etkisi arastırıldı. Biyosensörün tekrar kullanılabilirliği ve raf ömrü tayin edildi. Biyolojik ortamlarda olabilecek girisimlerin biyosensör cevabı üzerine etkileri incelendi.In this study, new amperometric biosensor for determination of glucose was developed. Polyaniline-polyvinylsulphonate-ferricyanide (PANIPVS- FC) and polyaniline-polyvinylsulphonate-methylene blue (PANIPVS- MB) films have been prepared on the platinum electrode by the electropolymerization of aniline was carried out in the presence of PVS, FC and MB. Optimum conditions of PANI-PVS-FC film was determined. Glucose oxidase enzyme has been immobilized in PANI-PVS-FC film via the entrapment method. Glucose detection is based on the oxidation of hydrogen peroxide and reduced form of ferricyanide at 0,3 V produced by the enzymatic reaction on the enzyme electrode surface. The linear working range of biosensor for glucose was determined. The effects of pH and temperature on the response of the glucose biosensor were investigated. Reusability and storage stability were determined of the biosensor. Interference effects were investigated on the amperometric response of the biosensor

An Investıgatıve Study Of The Bıocompatıbılıty, Surface And Corrosıon Propertıes Of Tıtanıum Alloys Modıfıed Wıth A Novel Bıonanocomposıte

Tıbbi alanda yaygın olarak kullanılan Ti-6Al-4V alaşımının korozyon ve biyolojik özelliklerini geliştirmek amacıyla, yeni bir nano biyokompozit olan kitosan (CS) /hidroksiapatit (HA) /zirkonyum oksit (ZA) üçlü kaplaması ile bu alaşımın yüzey modifikasyonu gerçekleştirildi. İlk aşamada, HA ve ZA nanotanecikleri ıslak çöktürme yöntemiyle sentezlendi. Sentezlenen bu nanotanecikler, CS ile birlikte, elektroforetik biriktirme yöntemiyle Ti-6Al-4V alaşımı üzerine kaplanarak CS/HA/ZA nano biyokompoziti elde edildi. Elektroforetik biriktirme yöntemi uygulanırken; bileşenlerin derişimleri, uygulanan potansiyel, kaplama süresi, ortam pH'ı gibi parametrelerin kaplamaya olan etkileri incelendi. Sentezlenen nanotaneciklerin ve elde edilen kaplamaların karakterizasyonu, Taramalı elektron mikroskobu (SEM), X-ışını difraktometresi (XRD) ve Fourier dönüşümlü kızılötesi spektrometresi (FTIR) ile yapıldı. Nano biyokompozitin kalınlığı, yüzey pürüzlülüğü ve temas açısı sırasıyla optik mikroskop, yüzey profilometresi ve temas açısı ölçme sistemi ile ölçüldü. Hidrofilik özellikteki, yaklaşık 150-200 μm kalınlığa ve 3,33 μm yüzey pürüzlülüğüne (Ra) sahip nano biyokompozitin, substrat yüzeyine tutunma kuvveti, üniversal test cihazıyla 2,11 MPa olarak bulundu. Tutunma kuvveti, kaplama süspansiyonundaki ZA derişimiyle doğru orantılı bir şekilde artmıştır. Nano indentasyon yöntemiyle yapılan ölçümler sonucunda; nano biyokompozitin, 32,9 MPa sertliğe ve 3,8 GPa Young modülüne sahip olduğu anlaşıldı. İkinci aşamada, nano biyokompozit ile kaplı Ti-6Al-4V alaşımının korozyon davranışı; kaplanmamış, CS ve CS/HA kaplı Ti-6Al-4V alaşımların korozyon davranışlarıyla karşılaştırma yapılarak; açık devre potansiyeli (OCP), potansiyodinamik polarizasyon ve elektrokimyasal empedans spektroskopisi (EIS) ölçümleriyle incelendi. Bu ölçümler sonucunda korozyon dirençleri sıralaması büyükten küçüğe doğru CS/HA/ZA > CS/HA > CS > kaplanmamış olarak bulundu. Atomik absorpsiyon spektrometresi sonuçlarına göre; 60 günlük sürede yapay biyolojik sıvı (SBF)'ya en az titanyum, nano biyokompozit ile kaplı Ti-6Al-4V alaşımından sızdı. MTT testi ile yapılan biyolojik değerlendirmeye göre ise, nano biyokompozit ile kaplı Ti-6Al-4V alaşımı, diğer kaplanmamış ve kaplı alaşımlardan daha iyi bir biyouyumluluk sergiledi.In this study, the surface modification of Ti-6Al-4V alloy used in the medical field was carried out with a new nano biocomposite, chitosan (CS) /hydroxyapatite (HA) /zirconia (ZA) triple coating, to improve its the corrosion and biological properties. In the first step, HA and ZA nanoparticles were synthesized by the wet precipitation method. These synthesized nanoparticles were coated on Ti-6Al-4V alloy by electrophoretic deposition together with chitosan to obtain CS/HA/ZA nanocomposite. When the electrophoretic deposition method is applied, the effects of coating parameters such as concentrations of components, applied potential, coating duration and ambient pH were investigated. The characterization of the synthesized nanoparticles and resulting coatings was performed by scanning electron microscopy (SEM) equipped with energy dispersive X-ray spectrometry, X-ray diffractometry (XRD) and Fourier transform infrared spectrometry (FTIR). The thickness, surface roughness and contact angle of the nanocomposite were measured by optical microscope, surface profilometer and contact angle measurement system, respectively. The hydrophilic nanobiocomposite which has the thickness of about 150-200 μm and the roughness (Ra) value of 3.33 μm adheres to Ti-6Al-4V surface with the strength of 2.11 MPa measured by universal testing machine. It is found that the adhesion strength increases with increasing ZA concentration in the deposition medium. As a result of the measurements made by the nanoindentation method, the nano biocomposite has the hardness of 32.9 MPa and the Young modulus of 3.8 GPa. In the second step, the corrosion behavior of Ti-6Al-4V alloy coated with CS/HA/ZA nanocomposite was investigated by open-circuit potential (OCP), potentiodynamic polarization and electrochemical impedance spectroscopy (EIS) measurements by comparing it to that of bare, CS and CS/HA coated ones. The order of corrosion resistance was found as: CS/HA/ZA > CS/HA > CS > bare. According to the results of atomic absorption spectrometry, the minimum amount of titanium that released to the simulated biological fluid (SBF) at the end of 60 days was from the nanobiocomposite coated Ti-6Al-4V alloy and MTT cytotoxicity test showed that it has the best biocompatibility among the other bare and coated alloys