scholarly journals Laboratory automation —some perspectives on the challenges in the implementation of the technology in pharmaceutical development

1998 ◽  
Vol 20 (4) ◽  
pp. 111-115 ◽  
Author(s):  
Nigel North ◽  
Simon Smith
Keyword(s):  
Drug Product ◽  
Clinical Information ◽  
Pharmaceutical Products ◽  
Successful Implementation ◽  
Laboratory Automation ◽  
Stability Studies ◽  
Product Analysis ◽  
Pharmaceutical Development ◽  
The Stability ◽  
Product Team

The intensifying pressure on reducing the development time for new pharmaceutical products is resulting in an increasing need for laboratory automation. A key element for the successful implementation of robotics for drug product analysis is the establishment of a reliable process for interaction of the automation team with its various customers, for example development product team and manufacturing group. The reduction of cycle time for product development appears to be resulting in more stability studies to support NDA/MAA filings for several reasons. Key clinical information may not be available before initiation of the stability studies and simultaneous world-wide development may result in an increase in the number of product strength and pack options.

scholarly journals Stability Studies of Transition Metal Chelates of 5-Bromosalicylidene-4-methoxyaniline andSalicylidene-2,3-dimethylaniline as Ligands

2011 ◽  
Vol 8 (4) ◽  
pp. 1911-1915
Author(s):  
N. G. Nadkarni ◽  
K. V. Mangaonkar
Keyword(s):  
Ionic Strength ◽  
Transition Metal ◽  
Stability Constants ◽  
Metal Chelates ◽  
Ternary Complexes ◽  
Water Medium ◽  
Stability Studies ◽  
Binary And Ternary Complexes ◽  
Transition Metal Chelates ◽  
The Stability

Binary and ternary complexes of the type M-Y and M-X-Y [M = Mn(II), Ni(II), Cu(II) and Zn(II); X = 5-bromosalicylidene-4-methoxyaniline and Y = salicylidene-2,3-dimethylaniline] have been examined pH-metrically at 27±0.5°C and at constant ionic strength, μ = 0.1 M (KCl) in 75 : 25(v/v) 1,4-dioxne-water medium. The stability constants for binary (M-Y) and ternary (M-X-Y) systems were calculated.

scholarly journals Microbiota of anaerobic digesters in a full-scale wastewater treatment plant

2017 ◽  
Vol 43 (3) ◽  
pp. 53-60 ◽  
Author(s):  
Piotr Świątczak ◽  
Agnieszka Cydzik-Kwiatkowska ◽  
Paulina Rusanowska
Keyword(s):  
Microbial Community ◽  
Sewage Sludge ◽  
Methane Production ◽  
Treatment Plant ◽  
Full Scale ◽  
Successful Implementation ◽  
Anaerobic Digesters ◽  
Syntrophic Bacteria ◽  
The Stability ◽  
Microbial Groups

AbstractAnaerobic digestion is an important technology for the bio-based economy. The stability of the process is crucial for its successful implementation and depends on the structure and functional stability of the microbial community. In this study, the total microbial community was analyzed during mesophilic fermentation of sewage sludge in full-scale digesters.The digesters operated at 34–35°C, and a mixture of primary and excess sludge at a ratio of 2:1 was added to the digesters at 550 m3/d, for a sludge load of 0.054 m3/(m3·d). The amount and composition of biogas were determined. The microbial structure of the biomass from the digesters was investigated with use of next-generation sequencing.The percentage of methanogens in the biomass reached 21%, resulting in high quality biogas (over 61% methane content). The abundance of syntrophic bacteria was 4.47%, and stable methane production occurred at a Methanomicrobia to Synergistia ratio of 4.6:1.0. The two most numerous genera of methanogens (about 11% total) wereMethanosaetaandMethanolinea, indicating that, at the low substrate loading in the digester, the acetoclastic and hydrogenotrophic paths of methane production were equally important. The high abundance of the orderBacteroidetes, including the classCytophagia(11.6% of all sequences), indicated the high potential of the biomass for efficient degradation of lignocellulitic substances, and for degradation of protein and amino acids to acetate and ammonia.This study sheds light on the ecology of microbial groups that are involved in mesophilic fermentation in mature, stably-performing microbiota in full-scale reactors fed with sewage sludge under low substrate loading.

scholarly journals Performance of the 4Kscore Test in Plasma and Serum and Stability of the Component Analytes in Clinical Samples

2018 ◽  
Vol 3 (2) ◽  
pp. 185-199 ◽  
Author(s):  
Christina E Higgins ◽  
Patricia Neybold ◽  
Marcella B Holdridge ◽  
Catherine R Barnes ◽  
Yan Dong ◽  
...  
Keyword(s):  
Dynamic Range ◽  
Specific Antigen ◽  
Clinical Information ◽  
Target Population ◽  
Clinical Samples ◽  
Free Psa ◽  
Total Prostate Specific Antigen ◽  
Edta Plasma ◽  
The Stability ◽  
Intact Psa

Abstract Background The 4Kscore Test determines a personalized risk score for aggressive prostate cancer by combining the blood sample measurements of total prostate-specific antigen (tPSA), free PSA (fPSA), intact PSA (iPSA), and human kallikrein-related peptidase 2 (hK2) with patient clinical information to generate the patient risk's score; thus, accuracy and precision of the 4Kscore depend on the reliability of these measurements. Although tPSA and fPSA are measured on a Food and Drug Administration (FDA)-approved platform, the performance of the iPSA and hK2 assays in the clinical setting has not previously been reported. Methods Analytical performance was determined for the iPSA and hK2 assays in both serum and EDTA plasma, according to Clinical and Laboratory Standards Institute guidelines. Equivalence of the 4Kscore in both sample matrices was demonstrated in a 353-patient clinical cohort, and the stability of endogenous iPSA and hK2 for at least 3 days was demonstrated in a smaller subset. Results Intralaboratory and interlaboratory precision of the iPSA and hK2 assays in both matrices was comparable with that of FDA-approved tPSA and fPSA assays (<18% for iPSA; <8% for hK2). The picogram per milliliter sensitivity and wide dynamic range of the iPSA and hK2 assays allowed for accurate measurements in the target population. The 4Kscore generated in either matrix up to 3 days after collection is equivalent to that measured within 24 h of collection (Passing–Bablok slope 95% CI: plasma, 0.999–1.034; serum, 0.997–1.040). Conclusions The robust performance of component assays and reliable stability of the endogenous analytes in clinical samples proven here ensures an accurate 4Kscore Test result.

Stability of extemporaneously prepared rosuvastatin oral suspension

2017 ◽  
Vol 74 (19) ◽  
pp. 1579-1583 ◽  
Author(s):  
Abdel Naser Zaid ◽  
Rania Shtayah ◽  
Ayman Qadumi ◽  
Mashour Ghanem ◽  
Rawan Qedan ◽  
...  
Keyword(s):  
Relative Humidity ◽  
High Performance ◽  
Room Temperature ◽  
Microbial Contamination ◽  
Active Pharmaceutical Ingredient ◽  
Storage Conditions ◽  
Dissolution Profile ◽  
Stability Studies ◽  
Organoleptic Properties ◽  
The Stability

Abstract Purpose The stability of an extemporaneously prepared rosuvastatin suspension stored over 30 days under various storage conditions was evaluated. Methods Rosuvastatin suspension was extemporaneously prepared using commercial rosuvastatin tablets as the source of active pharmaceutical ingredient. The organoleptic properties, dissolution profile, and stability of the formulation were investigated. For the stability studies, samples of the suspension were stored under 2 storage conditions, room temperature (25 °C and 60% relative humidity) and accelerated stability chambers (40 °C and 75% relative humidity). Viscosity, pH, organoleptic properties, and microbial contamination were evaluated according to the approved specifications. High-performance liquid chromatography was used for the analysis and quantification of rosuvastatin in selected samples. Microbiological investigations were also conducted. Results The prepared suspension showed acceptable organoleptic properties. It showed complete release of rosuvastatin within 15 minutes. The pH of the suspension was 9.8, which remained unchanged during the stability studies. The microbiological investigations demonstrated that the preparation was free of any microbial contamination. In addition, the suspension showed stability within at least the period of use of a 100-mL rosuvastatin bottle. Conclusion Extemporaneously prepared rosuvastatin 20-mg/mL suspension was stable for 30 days when stored at room temperature.

scholarly journals FORMULATION, CHARACTERIZATION AND STABILITY STUDY OF FAST DISSOLVING THIN FILM CONTAINING ASTAXANTHIN NANOEMULSION USING HYDROXYPROPYLMETHYL CELLULOSE POLYMER

2021 ◽  
pp. 17-22
Author(s):  
LUSI NURDIANTI ◽  
IYAN SOPYAN ◽  
TAOFIK RUSDIANA
Keyword(s):  
Thin Film ◽  
Mechanical Characteristics ◽  
Storage Conditions ◽  
Stability Study ◽  
Matrix System ◽  
Stability Studies ◽  
Casting Method ◽  
Hydroxypropylmethyl Cellulose ◽  
The Stability ◽  
Physical And Mechanical Characteristics

Objective: The present study was conducted to formulate and characterize the thin film containing astaxanthin nanoemulsion (TF-ASN) using Hydroxypropylmethyl Cellulose (HPMC) polymer as a film matrix system. The stability studies in different storage conditions were also performed. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using self-nanoemulsifying method, followed by incorporation into the HPMC matrix system by solvent casting method to forming TF-ASN. Evaluation of TF-ASN was performed by physical and mechanical characterizations. Stability study was carried out in both of accelerated (temperature of 40±2 °C/75±5% RH) and non-accelerated (at ambient temperature) conditions. Assay of astaxanthin in individual TF-ASN was determined compared to pure astaxanthin. Results: TF-ASN had good physical and mechanical characteristics that suitable for intraoral administration. Conclusion: For the study of stability under different storage conditions, it was proven that nanoemulsion form was packed in a HPMC matrix could enhance the stability of the astaxanthin.

scholarly journals Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)

2018 ◽  
Vol 6 (2) ◽  
pp. 67-71 ◽  
Author(s):  
Ravish Patel ◽  
Amit Patel ◽  
Tejasvini Gohil
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Regulatory System ◽  
Drug Approval ◽  
Oral Dosage ◽  
Market Regulation ◽  
Product Analysis ◽  
Regulatory Requirement ◽  
Generic Drug Product ◽  
Asean Countries

Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.

scholarly journals Stability study of rock slope in fractured quartzite at right side of spillway, Middle Marsyangdi Hydroelectric Project, Nepal

2003 ◽  
Vol 28 ◽  
Author(s):  
Kaustubh Mani Nepal ◽  
Roger Olsson
Keyword(s):  
Rock Slope ◽  
Stability Study ◽  
Cut Slope ◽  
Stability Studies ◽  
Hydroelectric Project ◽  
The Stability ◽  
The Right ◽  
Cut Slopes

A 120 m long and 68 m high rock cut slope is designed at the right side of spillway of Middle Marsyangdi Hydroelectric Project. This paper describes the stability studies performed for the rock cut slopes in jointed quartzite for foundation of spillway.

Assembly of discrete and oligomeric structures of organotin double-decker silsesquioxanes: inherent stability studies

2021 ◽  
Author(s):  
Pushparaj Loganathan ◽  
Renjith S. Pillai ◽  
Velusamy Jeevananthan ◽  
Ezhumalai David ◽  
Nallasamy Palanisami ◽  
...  
Keyword(s):  
Crystal Lattice ◽  
Computational Study ◽  
Stability Studies ◽  
Double Decker ◽  
The Stability ◽  
Inherent Stability

Discrete and oligomeric organotin DDSQs have been synthesized and characterized, both experimentally and through computational study. The stability of these compounds remains intrigued with the organization of their structure in the crystal lattice.

Safety and Evidence of Off-Label Use of Approved Drugs at the National Cancer Center Hospital in Japan

2020 ◽  
pp. OP.20.00131
Author(s):  
Seiko Bun ◽  
Kan Yonemori ◽  
Hiroko Sunadoi ◽  
Rena Nishigaki ◽  
Emi Noguchi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Products ◽  
National Cancer Center Hospital ◽  
Phase Iii ◽  
Cancer Center ◽  
Off Label Use ◽  
Pharmaceutical Development ◽  
Off Label ◽  
Center Hospital ◽  
Label Use

PURPOSE: In Japan, for pharmaceutical products to be covered by public medical insurance, their efficacy and safety must first be confirmed in clinical trials. To our knowledge, this study is the first investigation into the off-label use of pharmaceutical products at a high-volume cancer treatment center in Japan. The objective of this study is to explore the framework necessary for future pharmaceutical development and regulatory approval in the field of oncology by surveying the frequency of and indications for off-label use of pharmaceutical products at the National Cancer Center Hospital in Tokyo, Japan. MATERIALS AND METHODS: The pharmaceutical products used off-label in daily practice from 2003 to 2015 at the National Cancer Center Hospital were retrospectively examined based on applications that had been submitted to an internal review committee requesting off-label use. RESULTS: A total of 1,390 applications were submitted during the study period. The most frequently used supporting documents were the results of phase II trials, followed by case series and phase III trials. The cancer most frequently treated with off-label drugs was sarcoma (15.1%), followed by urologic cancer (9.2%) and GI cancer (7.6%). CONCLUSION: As reported in previous studies, pharmaceutical products were generally used off-label for the treatment of rare cancers, for which large-scale clinical trials are difficult to conduct. Continued discussion of the types of frameworks that are needed to guide pharmaceutical development is necessary.

scholarly journals Design and evaluation of Pulsatile drug delivery of Losartan Potassium

2014 ◽  
Vol 12 (2) ◽  
pp. 119-123
Author(s):  
MS Ashwini ◽  
Mohammed Gulzar Ahmed
Keyword(s):  
In Vitro Release ◽  
Losartan Potassium ◽  
Stability Studies ◽  
In Vitro Drug Release ◽  
Drug Content ◽  
Weight Variation ◽  
Release Studies ◽  
The Stability ◽  
Vitro Release

The study was designed for the investigation of pulsatile device to achieve time or site specific release of Losartan potassium based on chronopharmaceutical considerations. The basic design involves the preparation of cross linked hard gelatin capsules by using formaldehyde, then the drug diluent mixture were prepared and loaded in, which was separated by using hydrogel plugs of different polymers of different viscosities. Prepared formulations were subjected to evaluation of various parameters like weight variation, percentage drug content, in vitro drug release and stability studies. Weight variation and percentage drug content results showed that they were within the limits of official standards. The in-vitro release studies revealed that the capsules plugged with polymer HPMC showed better pulsatile or sustained release property as compared to the other formulations. The stability studies were carried out for all the formulations and formulations F1 & F2 were found to be stable. Dhaka Univ. J. Pharm. Sci. 12(2): 119-123, 2013 (December) DOI: http://dx.doi.org/10.3329/dujps.v12i2.17610

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