Propylene glycol free 5% minoxidil lotion formulation: cosmetic acceptability, local tolerability, clinical efficacy and in-vitro skin absorption evaluations

Background and Trial Objectives: A new propylene glycol (PG)-free 5% minoxidil (Mnx) (PG-Free-Mnx) lotion has been recently commercialized. Clinical efficacy and local tolerability have been, so far, documented in a limited number of patients. The aim of this study was to evaluate the clinical efficacy, cosmetic acceptability, and local tolerability of 6-month application of this new PG-Free Mnx lotion in a real-life situation. Materials and Methods: The NOMINAL (NO-PG MINoxidil reAL life study) trial was performed in 22 out-patients Italian dermatology clinics. A total of 196 subjects of both sexes with a diagnosis of androgenic alopecia (AGA) and female androgenic alopecia (FAGA) were enrolled in the trial, after their written informed consent. PG-Free-Mnx lotion was applied 1 ml twice daily for 6 months. Clinical efficacy was evaluated in an open fashion in all the enrolled subjects with a 5-grade scale score (from-2: severe worsening, to +2: very good improvement in comparison with baseline condition). In a subgroup of subjects (n=60) an assessor-blinded clinical efficacy evaluation has been also performed using high definition standardized and coded scalp global pictures at baseline, and after 6 months by an assessor unaware of the temporal sequence using a 3-grade score (from 0: no improvement to 3: very high improvement). Cosmetic acceptability evaluation was assessed using a 7-item questionnaire using a 10-point scale score, with score 1 meaning not at all and score 10 meaning the worst possible condition. Cosmetic acceptability and clinical efficacy were evaluated after 12 and 24 weeks of treatment. Global tolerability, assessed at week 24, was evaluated with a 4-grade scale score (from -1: very low tolerability to +2: very good tolerability). Results: All but seven (3.6%) subjects concluded the study. Clinical efficacy scores (open evaluation) were 0.8±0.7 and 1.0±0.7 at week 12 and 24, respectively. Good or very good clinical response (score +1 or +2) at week 12 and week 24 was observed in 64% and 74% respectively of the subjects with a similar response in women (75%) and men (73%). Baseline severity of AGA/FAGA was inversely correlated with the clinical response with a better outcome in subjects with AGA type II in comparison with subjects with types III/IV AGA. The clinical efficacy was confirmed by the assessor-blinded evaluation of the subgroup of 60 subjects’ pictures at baseline (clinical score at baseline: 0.2±0.4 vs. 1.8±0.7 after 6 months; p=0.0001; absolute mean difference: 1.6; 95% CI: 1.1 to 2.0). Cosmetic acceptability score mean values were always <2 at each time-point evaluation, demonstrating good or very good acceptability. Global Tolerability score mean±SD value was 1.7±0.4 with 94% of the subjects reporting good or very good tolerability with no differences between men and women. No subjects reported severe or very severe (Tolerability score >7) burning, itching or redness sensations. Conclusions: This new PG-free lotion shows, in real-life conditions, a very good cosmetic acceptability and tolerability profile. Clinical efficacy, evaluated both in open and assessor-blinded fashions, was also documented, and it was in line with the available data of traditional Mnx formulations with propylene glycol.

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Faculty Opinions recommendation of Contradiction between in vitro and clinical outcome: intravenous followed by oral azithromycin therapy demonstrated clinical efficacy in macrolide-resistant pneumococcal pneumonia.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718257908.793498790 ◽

2014 ◽

Author(s):

Charles Feldman

Keyword(s):

Clinical Outcome ◽

Clinical Efficacy ◽

Pneumococcal Pneumonia ◽

Oral Azithromycin

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Review on the Clinical Pharmacology of Hydroxychloroquine Sulfate for the Treatment of COVID-19

Current Drug Metabolism ◽

10.2174/1389200221666200610172929 ◽

2020 ◽

Vol 21 (6) ◽

pp. 427-435 ◽

Cited By ~ 1

Author(s):

Cheng Cui ◽

Siqi Tu ◽

Valerie Sia Jie En ◽

Xiaobei Li ◽

Xueting Yao ◽

...

Keyword(s):

Drug Interactions ◽

Clinical Efficacy ◽

Relevant Literature ◽

The United States ◽

Efficacy And Safety ◽

Open Label ◽

Infected People ◽

Treatment Regimens ◽

Therapeutic Drugs

Background: As the number of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infected people is greatly increasing worldwide, the international medical situation becomes very serious. Potential therapeutic drugs, vaccine and stem cell replacement methods are emerging, so it is urgent to find specific therapeutic drugs and the best treatment regimens. After the publications on hydroxychloroquine (HCQ) with anti- SARS-COV-2 activity in vitro, a small, non-randomized, open-label clinical trial showed that HCQ treatment was significantly associated with reduced viral load in patients with coronavirus disease-19 (COVID-19). Meanwhile, a large prophylaxis study of HCQ sulfate for COVID-19 has been initiated in the United States. HCQ offered a promising efficacy in the treatment of COVID-19, but the optimal administration is still being explored. Methods: We used the keyword "hydroxychloroquine" to conduct a literature search in PubMed to collect relevant literature on the mechanism of action of HCQ, its clinical efficacy and safety, pharmacokinetic characteristics, precautions for clinical use and drug interactions to extract and organize information. Results: This paper reviews the mechanism, clinical efficacy and safety, pharmacokinetic characteristics, exposureresponse relationship and precautions and drug interactions of HCQ, and summarizes dosage recommendations for HCQ sulfate. Conclusion: It has been proved that HCQ, which has an established safety profile, is effective against SARS-CoV-2 with sufficient pre-clinical rationale and evidence. Data from high-quality clinical trials are urgently needed worldwide.

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Nanovesicles Loaded with Origanum onites and Satureja thymbra Essential Oils and Their Activity against Food-Borne Pathogens and Spoilage Microorganisms

Molecules ◽

10.3390/molecules26082124 ◽

2021 ◽

Vol 26 (8) ◽

pp. 2124

Author(s):

Giulia Vanti ◽

Ekaterina-Michaela Tomou ◽

Dejan Stojković ◽

Ana Ćirić ◽

Anna Rita Bilia ◽

...

Keyword(s):

Essential Oils ◽

Propylene Glycol ◽

Antimicrobial Properties ◽

Spherical Shape ◽

Food Borne Pathogens ◽

Food Borne ◽

Spoilage Microorganisms ◽

Satureja Thymbra ◽

Origanum Onites

Food poisoning is a common cause of illness and death in developing countries. Essential oils (EOs) could be effective and safe natural preservatives to prevent and control bacterial contamination of foods. However, their high sensitivity and strong flavor limit their application and biological effectiveness. The aim of this study was firstly the chemical analysis and the antimicrobial evaluation of the EOs of Origanum onites L. and Satureja thymbra L. obtained from Symi island (Greece), and, secondly, the formulation of propylene glycol-nanovesicles loaded with these EOs to improve their antimicrobial properties. The EOs were analyzed by GC-MS and their chemical contents are presented herein. Different nanovesicles were formulated with small average sizes, high homogeneity, and optimal ζ-potential. Microscopic observation confirmed their small and spherical shape. Antibacterial and antifungal activities of the formulated EOs were evaluated against food-borne pathogens and spoilage microorganisms compared to pure EOs. Propylene glycol-nanovesicles loaded with O. onites EO were found to be the most active formulation against all tested strains. Additionally, in vitro studies on the HaCaT cell line showed that nanovesicles encapsulated with EOs had no toxic effect. The present study revealed that both EOs can be used as alternative sanitizers and preservatives in the food industry, and that their formulation in nanovesicles can provide a suitable approach as food-grade delivery system.

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Effects of propylene glycol on in vitro ruminal fermentation, methanogenesis, and microbial community structure

Journal of Dairy Science ◽

10.3168/jds.2020-18974 ◽

2021 ◽

Author(s):

K. Wang ◽

X.M. Nan ◽

Y.G. Zhao ◽

J.J. Tong ◽

L.S. Jiang ◽

...

Keyword(s):

Community Structure ◽

Microbial Community ◽

Propylene Glycol ◽

Microbial Community Structure ◽

Ruminal Fermentation

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Telithromycin: The First of the Ketolides

Annals of Pharmacotherapy ◽

10.1345/aph.1a038 ◽

2002 ◽

Vol 36 (3) ◽

pp. 452-464 ◽

Cited By ~ 37

Author(s):

Christopher S Shain ◽

Guy W Amsden

Keyword(s):

Respiratory Tract ◽

Clinical Efficacy ◽

Respiratory Tract Infections ◽

Safety Issue ◽

Qtc Interval ◽

Phagocytic Cells ◽

Medline Search ◽

Atypical Pathogens ◽

Tract Infections

OBJECTIVE: To review the chemistry, spectrum of activity, pharmacology, clinical efficacy, and safety of telithromycin. DATA SOURCES: A MEDLINE search from 1966 to December 2000 was performed via OVID and PubMed using the following search terms: HMR 3647, HMR3647, Ketek, RU 66647, and telithromycin. An extensive review of retrieved literature, abstracts from international scientific conferences, and minutes from regulatory authority meetings was also performed. DATA EXTRACTION: Medicinal chemistry, in vitro, animal, and human trials were reviewed for information on the antimicrobial activity, clinical efficacy, pharmacology, and safety of telithromycin. DATA SYNTHESIS: Several chemical modifications to the macrolide structure have led to the development of telithromycin, the first ketolide antimicrobial that demonstrates improved activity against penicillin- and macrolide/azalide-resistant Streptococcus pneumoniae due to its unique binding to the ribosomal target site. Although telithromycin may be useful in the treatment of community-acquired respiratory tract infections due to its activity against common typical and atypical pathogens, questions concerning its reliable activity against Haemophilus influenzae need to be addressed. Telithromycin's pharmacokinetics permit once-daily dosing for abbreviated periods and good distribution into lung tissue and phagocytic cells. Clinical and bacteriologic cure rates have been similar to those of comparator agents in human efficacy trials; however, the incidence of adverse gastrointestinal events were generally higher with telithromycin patients. Like other macrolides and many newer fluoroquinolones, telithromycin's ability to prolong the QTc interval is a potential safety issue, especially in elderly patients with predisposing conditions or those who are concurrently receiving drugs that are substrates for CYP2D6 and 3A4. Liver function test elevations demonstrated during clinical trials, although not overtly severe, may warrant monitoring in some patients taking multiple hepatically metabolized/cleared agents. CONCLUSIONS: Telithromycin offers potential advantages over traditional macrolides/azalides for community-acquired respiratory tract infections caused by macrolide-resistant pathogens. Further studies are needed to elucidate its clinical efficacy against H. influenzae, potential drug interactions, and safety in various subpopulations.

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COMPARATIVE EVALUATION OF SELECTED POLYMERS AND PLASTICIZER ON TRANSDERMAL DRUG DELIVERY SYSTEM

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2018v10i1.21960 ◽

2018 ◽

Vol 10 (1) ◽

pp. 67

Author(s):

Bhawana Sethi ◽

Rupa Mazumder

Keyword(s):

Drug Delivery ◽

Drug Release ◽

Propylene Glycol ◽

Drug Delivery System ◽

Transdermal Drug Delivery ◽

Release Kinetics ◽

Content Uniformity ◽

Transdermal Drug Delivery System ◽

Transdermal Patches

Objective: The present work was aimed at preparation of transdermal patches by a solvent casting method using a varying concentration of polymers i.e. methocel (K15 and K100), ethocel (4 and 10), gelatin, chitosan, eudragit (RL and RS) grade using plasticizer (glycerin and propylene glycol).Methods: The ratio of drug to polymers and plasticizer was varied and the effect of formulation variables was studied. Prepared transdermal patches were evaluated for physicochemical properties, in-vitro permeation studies, content uniformity, primary skin irritation studies and FT-IR studies.Results: The formulated transdermal patch by using Methocel K 100 M showed good physical properties. The average weight of patches prepared using glycerin as a plasticizer were ranged from 42.33-67.00 mg and propylene glycol as a plasticizer were ranged from 40.67-67.67 mg. The percentage moisture absorption varies from 1.76 to 10.73 for patches formulated using glycerin and 2.28 to 7.97 for propylene glycol patches. The percentage moisture loss from patches prepared using glycerin was ranged from 2.75 to 11.54 and 2.87 to 12.02 from propylene glycol. The water vapour transmission rate from patches prepared using glycerin was ranged from 0.25 to 0.92 and 0.41 to 1.76. The formulated patch showed the acceptable quantity of medicament ranged from (100.20-101.05%). This result met the test content uniformity as per BP (85% to 115%). According to that, the drug was consistent throughout the patches. The formulation PGD is considered as the best formulation, since it shows a maximum in vitro drug release as 43.75 % at 24 h. The drug release kinetics studied showed that the majority of formulations was following zero order.Conclusion: In conclusion, controlled release transdermal drug delivery system patches of aliskiren can be prepared using polymer combinations, with a different plasticizer. The release rate of drug depends upon the polymer. However, release kinetics followed zero order.

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Florfenicol - pharmacodynamic, pharmacokinetics and clinical efficacy of oral formulations in domestic animals: A systematic review

Veterinarski glasnik ◽

10.2298/vetgl0506635s ◽

2005 ◽

Vol 59 (5-6) ◽

pp. 635-654 ◽

Cited By ~ 1

Author(s):

Leon Scuka

Keyword(s):

Systematic Review ◽

Clinical Efficacy ◽

Meta Analysis ◽

Clinical Signs ◽

Domestic Animals ◽

Oral Solution ◽

Favorable Effect ◽

Respiratory Pathogens ◽

Oral Formulations

Porcine respiratory disease complex (PRDC) is a major economic problem for swine producers world-wide. Pharmacodynamic, pharmacokinetics and clinical efficacy of florfenicol oral formulations in domestic animals were evaluated. For this purpose the systematic review and meta-analysis were done. In vitro efficacy of florfenicol showed that this drug is highly effective against most important respiratory pathogens. All these facts are shown in our survey. Three studies in pigs were relevant to include in the meta-analysis, which showed that results in the florfenicol group were better than in comparative control groups in all observed parameters: clinical signs, lung lesions and resolution of Actinobacillus pleuropneumoniae (P<0,001). A second meta-analysis with 7 studies showed that the usage of florfenicol reduces mortality in pig herds with PRDC (P<0.05). Other field trials in pigs using florfenicol oral forms where reviewed. After treatment with florfenicol oral solution there was a significant drop of mortality in both groups of pigs (P<0.01); eg. one using florfenicol oral solution in treating PRDC (n=85) and another mixed pneumoenteric infection (n=54). Analysis of data when using premix in pigs (n=118) also suggests that a medicated premix has a favorable anti-infectious effect on pigs, irrespective of the group of animals or the evolution stage of the disease. Finally, favorable effect of florfenicol in treating swine ileitis was also presented. Regarding their pharmacokinetics, in vitro and clinical efficacy of florfenicol oral forms, they should be considered as a powerful tool for combating complex infections that are frequently met in intensive animal production.

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