Investigation Of Dissolution Performance And Physical Characterization On Development Of Solid Dispersion Dosage Form

Solid dispersion (SD) formulation has attracted much attention due to its potential in enhancing dissolution performance of poorly soluble active pharmaceutical ingredients (API). However, an overview of the dissolution performance of SDs implies inconsistent degree of dissolution improvement of poorly soluble APIs in SD. Therefore, the main objective of this study is to determine the criteria of a good carrier system and drug candidate for enhanced dissolution performance of a solid dispersion system for a poorly soluble drug and dosage form consideration particularly the impact of compaction. To achieve these objectives, several SD systems were prepared in this study by spray drying and quenche

An investigation into the factors governing the degree of dissolution enhancement of solid dispersion for poorly soluble drugs

Solid dispersion (SD) formulation has attracted muchattention due to its potential in enhancing dissolutionperformances of poorly soluble active pharmaceutical ingredients(API). Recently, a review on dissolution performances of SDsclassifies the improvement into 3 categories, where 82 % of thestudies showed improved bioavailability, 8 % showed reducedbioavailability and 10 % revealed similar bioavailability ascompared to pure APIs. This indicates the inconsistent degrees ofdissolution improvement of poorly soluble APIs in SD. Althougha few factors related to the choice of carriers have been suggestedto contribute to the dissolution improvement, however, theunderlying factor determining the discrepancy in the degree ofdissolution improvement remains in vague. It is hypothesizedthat the API contributes to the degree of dissolutionimprovement of SD. Hence, the factor of amorphous solubilityadvantage of API which leads to the different degrees ofdissolution enhancement of SD is investigated in this research.Polyvinylpyrrolidone vinyl acetate (PVPVA)-based SD isprepared with three poorly soluble APIs. Physicochemicalproperties of SD were characterized using infrared spectroscopy,differential scanning calorimetry (DSC) and X-ray powderdiffraction. The dissolution efficiency of each SD was calculatedand compared to physical mixture and pure API. Theoreticalamorphous solubility advantage for each API was calculatedusing the thermal properties obtained from DSC. The calculatedvalues were found to be correlating well with the dissolutionenhancement of the respective SDs. Hence, this theoreticalapproach can be utilized as an initial screening tool of APIcandidates in SD formulation during early pharmaceuticaldevelopment

Exploring the quality of life of cosmetic users: A cross-sectional analysis from eight Arab countries in the Middle East

Background The use of cosmetic products is growing in dominance in the Arab population, making it essential to measure its effects on users. The production of cosmetics has been largely driven by consumerism and a bid to keep abreast with the latest trends in the beauty industry with less attention on how the users' quality of life (QoL) is affected. Aims This study aims to investigate the effect of cosmetic products on users' quality of life in eight Arab countries. Methods A cross-sectional study was carried out using an online data collection approach. A validated and specialist instrument tool called BeautyQoL, which consists of five domains and a total of 52 questions, was distributed to a sample of 2219 cosmetic users. Descriptive and inferential statistical analysis was done using SPSS® version 26.0. Results The mean age of participants was 34 ± 11.25 years, and more women were represented in the sample (71%) than men. The majority of respondents had oily skin type (39.6%) and tan skin tone (30.4%). QoL through cosmetic use is computed with a mean score of 51 out of 100. The users' mean score satisfaction from cosmetic use is centred on attractiveness (56.1), followed by self-confidence (51.8). Cosmetics have a statistically significant effect on participants who are young adults, women, single, and employed with high income. As the respondents' skin tone deepens from very fair to dark, the mean score for each domain significantly increases, whereas when skin type changes from very oily to dry, the mean score for each domain decreases. Conclusion The effect of cosmetics on the users' QoL is limited, contrary to the narrative commonly portrayed in cosmetics' advertisements. Therefore, the use of cosmetics among the Arab population should be from an informed perspective of their specific needs instead of conforming to the viral trends pedaled by influencers and bloggers on social media, which might be irrelevant for them.Open access publishing facilitated by Monash University, as part of the Wiley - Monash University agreement via the Council of Australian University Librarians. [Correction added on 5 July 2022, after first online publication: CAUL funding statement has been added.]Scopu

Prognostic model to predict postoperative acute kidney injury in patients undergoing major gastrointestinal surgery based on a national prospective observational cohort study.

Background: Acute illness, existing co-morbidities and surgical stress response can all contribute to postoperative acute kidney injury (AKI) in patients undergoing major gastrointestinal surgery. The aim of this study was prospectively to develop a pragmatic prognostic model to stratify patients according to risk of developing AKI after major gastrointestinal surgery. Methods: This prospective multicentre cohort study included consecutive adults undergoing elective or emergency gastrointestinal resection, liver resection or stoma reversal in 2-week blocks over a continuous 3-month period. The primary outcome was the rate of AKI within 7 days of surgery. Bootstrap stability was used to select clinically plausible risk factors into the model. Internal model validation was carried out by bootstrap validation. Results: A total of 4544 patients were included across 173 centres in the UK and Ireland. The overall rate of AKI was 14·2 per cent (646 of 4544) and the 30-day mortality rate was 1·8 per cent (84 of 4544). Stage 1 AKI was significantly associated with 30-day mortality (unadjusted odds ratio 7·61, 95 per cent c.i. 4·49 to 12·90; P < 0·001), with increasing odds of death with each AKI stage. Six variables were selected for inclusion in the prognostic model: age, sex, ASA grade, preoperative estimated glomerular filtration rate, planned open surgery and preoperative use of either an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. Internal validation demonstrated good model discrimination (c-statistic 0·65). Discussion: Following major gastrointestinal surgery, AKI occurred in one in seven patients. This preoperative prognostic model identified patients at high risk of postoperative AKI. Validation in an independent data set is required to ensure generalizability

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Effect of Antiplatelet Therapy on Survival and Organ Support–Free Days in Critically Ill Patients With COVID-19

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