scholarly journals BIOWAIVER STUDY OF IMMEDIATE RELEASE GLIMEPIRIDE TABLETS

2021 ◽  
pp. 187-192
Author(s):  
SIHAM ABDOUN ◽  
DALIA GABER ◽  
RAGHAD ALWAHABI ◽  
NASHWA ALQUSSIR ◽  
NEHAL ALMUTAIRI ◽  
...  
Keyword(s):  
Quality Standards ◽  
Immediate Release ◽  
Efficacy And Safety ◽  
Originator Brand ◽  
Therapeutic Equivalency ◽  
Dissolution Apparatus ◽  
Generic Products ◽  
Similarity And Difference ◽  
Tablet Dosage

Objective: Demonstrating therapeutic equivalency regarding the efficacy and safety among originator products and generics is a key step in permitting the marketing of generic products. The study aimed to evaluate the bioequivalence of five different generic brands of Glimepiride tablets under biowaiver conditions. Methods: The quality of the tablet products, including uniformity of weight, friability, and disintegration test, was assessed using the United State Pharmacopeia (USP) general monograph for the tablet dosage form. The content of glimepiride in the tablets was measured using UV spectrophotometer at the wavelength 229 nm. The release of Glimepiride from the tested and originator tablet products was evaluated using the dissolution profiles conducted in HCI buffer pH 1.2, and phosphate buffer pH 6.4 and 7.8 by USP dissolution apparatus II. The bioequivalence of test products was assessed using the similarity and difference factors.  Results:The tested products complied to USP requirements for quality standards; all the products show rapid disintegration, D1 show higher time (Three minutes) while D3 show lower time (28 seconds). The content of test products was (104.68, 93.75, 97.21, 97.03, and 102.10) for D1, D2, D3, D4, and D5 , respectively, compare to 103.70 for OB. Dissolution profiles revealed that the highest similarity to the originator was showed in pH 6.4; f2 ranged (74.5-68.4) for all the tested products and low similarity in pH 7.8; f2 ranged (45.2-64.7). Conclusion: The study showed that the generic products has noticeable similarity with the originator brand and it can be interchangeable.

EQUIVALENCE STUDY OF IMMEDIATE RELEASE TABLETS OF BETA BLOCKER DRUG

2020 ◽  
pp. 53-59
Author(s):  
DALIA GABER ◽  
SIHAM ABDOUN ◽  
HAMZAH MASWADEH ◽  
EBTIHAL ALNASSR ◽  
MARAM AL SALAMAH
Keyword(s):  
Dissolution Kinetics ◽  
Immediate Release ◽  
Therapeutic Equivalence ◽  
Physiochemical Properties ◽  
Regulatory Bodies ◽  
Dissolution Apparatus ◽  
Generic Products ◽  
Similarity And Difference ◽  
Kinetics Of ◽  
Higuchi Model

Objective: The therapeutic equivalence of generic brands is a great challenge for manufacturers. This study aimed to evaluate the bioequivalence of four different generic brands of atenolol tablets under biowaiver conditions. Methods: Physiochemical properties of the tablet products namely uniformity of weight, hardness, disintegration, and drug content were assessed. The dissolution profiles of atenolol tablets were conducted in pH 1.2, 4.5, 6.8 and 7.6 buffers using USP dissolution apparatus II. Similarity and difference factors were calculated. Finally, four kinetic models have been offered to describe the release characteristics of atenolol under experiment conditions. Results: All tablets showed accepted physiochemical characters. Dissolution profiles revealed that G2 showed the highest similarity to innovator (f2 91.86) in pH 7.6. Dissolution kinetics of G2 at the same pH could be best described as Higuchi model of release.  Conclusion: The study showed that excipients and manufacturing practices play an important role in marketing biowaiver generic products meet the international regulatory bodies criteria.

Studi fortifikasi hidrolisat protein udang rebon (mysis relicta) pada mie sagu

2020 ◽  
Vol 6 (1) ◽  
pp. 039
Author(s):  
Trie Omitha Purba ◽  
Suparmi Suparmi ◽  
Dahlia Dahlia
Keyword(s):  
Experimental Method ◽  
Proximate Composition ◽  
Protein Hydrolysate ◽  
Quality Standards ◽  
Processing Technology ◽  
Fish Processing ◽  
Mysis Relicta ◽  
Marine Chemistry ◽  
Randomized Design

The study aimed to determine the effect of rebon shirmp (mysis relicta) protein hydrolisate fortification to the sago noodles and to observe the characteristics of the sago noodles produced. The research was carried on in February – April 2019 in the  Laboratory of Fish Processing Technology, Integrated Laboratories, and the Fisheries and Marine Chemistry Laboratories at the Universitas Riau. The method used was the experimental method, designedas a non-factorial complete randomized design. The treatment conducted was addingof rebon shrimp protein hydrolysate at 4 level concentrations (0%, 5%, 10% dan 15%). The variables assessed were the quality of organoleptic (appearance, texture, odor, flavor) and the proximate composition. The results showed that the proteinhydrolysate of rebon shrimp at concentration of 15% was the best treatment and in accordance to the quality standards of dried noodles (SNI 01-2974-1996), indicated bythe highest organoleptic qualityof the dried noodles produced, including: the appearance that was brown, less attractive, whole, less neat; the texture that was dry and compact; the aroma that was quite fragrant, spesific rebon shrimp; and the taste that was quite tasty and shrimp flavored. The proximate composition ofthe best product was presented by the content of moisture, ash, fat, protein, and carbohydrate at 7.55%,1.02%, 0.17%, 16.76%, and 74.49%, respectively.Keywords: Hydrolysate protein, rebon shrimp, sago noodles

Management and Status of Japanese Public Waters

1991 ◽  
Vol 23 (1-3) ◽  
pp. 1-10 ◽  
Author(s):  
Takeshi Goda
Keyword(s):  
Water Quality ◽  
Coastal Waters ◽  
Industrial Wastewater ◽  
Quality Standards ◽  
Water Bodies ◽  
Industrial Wastewaters ◽  
Quality Of Water ◽  
Japanese Rivers ◽  
Per Capita

The management and status of public water bodies in Japan is discussed. The environmental quality standards which have been set and the levels of compliance with these standards are shown. The water quality of Japanese rivers, lakes, reservoirs, wetlands and coastal waters is described, and eutrophication problems are mentioned. The effects of changes in population density and levels of recycling of industrial wastewaters on the quality of water bodies are discussed. Almost 75% of industrial wastewater is now recycled. Per capita availability of freshwater in Japan is comparatively low, and the construction of 530 dams, in addition to the 2393 dams already in operation, is planned. Irrigation effluents from paddy fields are a major factor which influences river water quality in Japan. The improvement of water quality using various methods is discussed.

What Advantages Can Be Expected from the Acceptance of Variable Quality Standards for Sewage Treatment Effluents?

1988 ◽  
Vol 20 (4-5) ◽  
pp. 249-251
Author(s):  
Jacques Bernard
Keyword(s):  
Water Quality ◽  
Sewage Treatment ◽  
Quality Standards ◽  
Quality Level ◽  
Environment Protection ◽  
Economical Benefit ◽  
Quality Objective ◽  
Set Up ◽  
Variable Quality

The flow and the water quality of the rivers vary throughout the year. Very frequently the environment protection authorities set up a quality objective for the river water and this mini mum quality level is constant. So, it wou1d seem possible to accept variable quality standards for plant effluents. A first approach of the problem,by a small French task group,based on three actual cases leads to the provisory conclusion that such a regulation is suitable and presents economical benefit only in some very limit ed cases.

scholarly journals Physicochemical Characterization Cascade of Nanoadjuvant–Antigen Systems for Improving Vaccines

Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 544
Author(s):  
Giuditta Guerrini ◽  
Antonio Vivi ◽  
Sabrina Gioria ◽  
Jessica Ponti ◽  
Davide Magrì ◽  
...  
Keyword(s):  
Immune Response ◽  
Protein Structure ◽  
Physicochemical Properties ◽  
Physicochemical Characterization ◽  
Protein Antigen ◽  
Efficacy And Safety

Adjuvants have been used for decades to enhance the immune response to vaccines, in particular for the subunit-based adjuvants. Physicochemical properties of the adjuvant-protein antigen complexes, such as size, morphology, protein structure and binding, influence the overall efficacy and safety of the vaccine. Here we show how to perform an accurate physicochemical characterization of the nanoaluminum–ovalbumin complex. Using a combination of existing techniques, we developed a multi-staged characterization strategy based on measurements of increased complexity. This characterization cascade has the advantage of being very flexible and easily adaptable to any adjuvant-protein antigen combinations. It will contribute to control the quality of antigen–adjuvant complexes and immunological outcomes, ultimately leading to improved vaccines.

scholarly journals Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yaping Wang ◽  
Bin Liu ◽  
Xiuqiong Fu ◽  
Tiejun Tong ◽  
Zhiling Yu
Keyword(s):  
Relapse Rate ◽  
Large Scale ◽  
Primary Outcome ◽  
Response Rate ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Efficacy And Safety ◽  
History Of ◽  
Non Ulcer Dyspepsia

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].

Efficacy and safety of beta-blockers and prolonged bronchodilators in patients with heart failure with coronary artery disease and moderate to severe COPD

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Evdokimov ◽  
E Yushchuk ◽  
A Evdokimova ◽  
S Ivanova ◽  
I Sadulaeva
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Condition ◽  
Blood Pressure Monitoring ◽  
Beta Blockers ◽  
Control Group ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Severe Copd

Abstract Purpose To compare clinical efficacy and safety of various treatment regimens with the inclusion of beta-blockers, RAAS antagonists (ACE inhibitors or ARBs), prolonged bronchodilators (LABA, LAMA) in heart failure patients with CAD and COPD. Methods 385 patients (292 men and 93 women), aged 66.3±4.1 years, with CHF classes II to III (NYHA) combined with moderate to severe COPD (GOLD) and with LVEF less than 45% were randomized into nine groups: enalapril + LAMA (control group), nebivolol + enalapril + LAMA, nebivolol + losartan + LAMA, nebivolol + losartan + LABA, nebivolol + losartan + LAMA/LABA, carvedilol + enalapril + LAMA, carvedilol + losartan + LAMA, carvedilol + losartan + LABA, carvedilol + losartan + LAMA/LABA. Patients of all groups received complex CHF treatment comprising diuretics, nitrates, cardiac glycosides (if necessary). Clinical examination, TTE, 6-minute walk test (6MWT), 24-hour electrocardiogram and blood pressure monitoring, respiratory function test were assessed at baseline and after 6 months of treatment. The quality of life was evaluated by MYHFQ, SGRQ and mMRC scale. Results After 6 months of therapy the improvement of clinical condition and quality of life were marked in all groups. At the end of observation period there was a significant improvement of patients clinical condition, quality of life, reduction of mean CHF FC and dyspnea severity, increase of exercise tolerance, slowing of progression of CHF and COPD, improvement of the parameters of intracardiac hemodynamics, structural and functional parameters of the left and right heart (a decrease in the size of the atria, LV volumes and internal dimension at end-diastole and end-systole, cardiac index, LVMMI, an increase of LVEF, a significant decrease in systemic vascular resistance and the pulmonary hypertension grade, significant improvement in systolic and diastolic function of the ventricles, regression of pathological remodeling of the heart, reduction of heart rate, duration and frequency of myocardial ischemia episodes (including its “silent” form). The best results were obtained in groups using a beta-blocker (nebivolol or carvedilol), a RAAS antagonist, and a combination of long-acting bronchodilators (indacaterol and tiotropium) – group 5 and 9. It is worth noting that beta-blockers, LABA and LAMA were well tolerated in all observation groups and serious adverse events were absent. Conclusions The appointment of 3-generation beta-blockers to patients with CHF on the background of CAD and COPD can significantly increase the effectiveness of treatment and does not cause a deterioration in spirometry in patients with such cardiopulmonary pathology. In our opinion, the most important point in the appointment of beta blockers to patients with moderate to severe COPD is low start dose and slow titration of the dose at the beginning of the therapy. It is advisable to include in the complex therapy of such patients a combination of LABA and LAMA as a basic bronchodilator support. Funding Acknowledgement Type of funding source: None

scholarly journals Conceptualizing and Fostering the Quality of CES Through a Dutch National Network on CES (NEON)

HEC Forum ◽  
2021 ◽  
Author(s):  
Laura Hartman ◽  
Guy Widdershoven ◽  
Eva van Baarle ◽  
Froukje Weidema ◽  
Bert Molewijk
Keyword(s):  
Quality Standards ◽  
Evaluation Methodology ◽  
Clinical Ethics Support ◽  
National Network ◽  
Responsive Evaluation ◽  
Evaluation Approach ◽  
Ethics Support ◽  
Similarities And Differences ◽  
The Relationship

AbstractThe prevalence of Clinical ethics support (CES) services is increasing. Yet, questions about what quality of CES entails and how to foster the quality of CES remain. This paper describes the development of a national network (NEON), which aimed to conceptualize and foster the quality of CES in the Netherlands simultaneously. Our methodology was inspired by a responsive evaluation approach which shares some of our key theoretical presuppositions of CES. A responsive evaluation methodology engages stakeholders in developing quality standards of a certain practice, instead of evaluating a practice by predefined standards. In this paper, we describe the relationship between our theoretical viewpoint on CES and a responsive evaluation methodology. Then we describe the development of the network (NEON) and focus on three activities that exemplify our approach. In the discussion, we reflect on the similarities and differences between our approach and other international initiatives focusing on the quality of CES.

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