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International Journal of Pharmaceutics May 2017The investigation of semisolid ophthalmic ointments is challenging due to their complex physicochemical properties and the unique anatomy of the human eye. Using Lotemax...
The investigation of semisolid ophthalmic ointments is challenging due to their complex physicochemical properties and the unique anatomy of the human eye. Using Lotemax as a model ophthalmic ointment, three different manufacturing processes and two excipient sources (Fisher (OWP) and Fougera (NWP)) were used to prepare loteprednol etabonate ointments that were qualitatively and quantitatively the same across the manufactured formulations. Physicochemical properties including drug content and uniformity, particle size and distribution, as well as rheological parameters (onset point, crossover modulus, storage modulus and Power law consistency index) were investigated. In addition, USP apparatus 2 with enhancer cells was utilized to study the in vitro drug release characteristics of the ophthalmic ointments. Both manufacturing processes and excipient sources had a significant influence on the physicochemical attributes and the in vitro drug release profiles of the prepared ointments. Ointments prepared via the hot melt processes exhibited higher rheological parameters and lower drug release rates compared to ointments prepared without hot melting. Ointments prepared with OWP demonstrated higher rheological parameters and lower in vitro drug release rates compared to ointments prepared with NWP. A strong correlation between the rheological parameters and in vitro drug release rate was shown using logarithmic linear regression. This correlation may be useful in predicting in vitro drug release from measured physicochemical properties, and identifying the critical quality attributes during the development of ointment formulations.
Topics: Administration, Ophthalmic; Drug Liberation; Loteprednol Etabonate; Ointments; Particle Size; Rheology; Solubility
PubMed: 28344172
DOI: 10.1016/j.ijpharm.2017.03.039 -
Journal of Ethnopharmacology Feb 2017Research in the field of wound healing is very recent. The concept of wound healing is changing from day to day. Ayurveda is the richest source of plant drugs for...
BACKGROUND AND AIMS
Research in the field of wound healing is very recent. The concept of wound healing is changing from day to day. Ayurveda is the richest source of plant drugs for management of wounds and Cynodon dactylon L. is one such. The plant is used as hemostatic and wound healing agent from ethnopharmacological point of view. Aim of the present study is scientific validation of the plant for wound healing activity in detail.
MATERIALS AND METHODS
Aqueous extract of the plant was prepared and phytochemical constituents were detected by HPLC analysis. Acute and dermatological toxicity study of the extract was performed. Pharmacological testing of 15% ointment (w/w) of the extract with respect to placebo control and standard comparator framycetin were done on full thickness punch wound in Wister rats and effects were evaluated based on parameters like wound contraction size (mm), tensile strength (g); tissue DNA, RNA, protein, hydroxyproline and histological examination. The ointment was applied on selected clinical cases of chronic and complicated wounds and efficacy was evaluated on basis of scoring on granulation, epithelialization, vascularity as well as routine hematological investigations.
RESULTS
Significant results (p<0.05) were observed both in pharmacological and clinical studies.
CONCLUSION
The present research with aqueous extract of Cynodon dactylon explores its potential wound healing activity in animal model and subsequent feasibility in human subjects. Phenolic acids and flavonoids present in c. dactylon supports its wound healing property for its anti-oxidative activity that are responsible for collagenesis.
Topics: Animals; Cynodon; Dermatologic Agents; Female; Male; Mice; Ointments; Phytotherapy; Plant Extracts; Rats; Rats, Wistar; Skin; Tensile Strength; Wound Healing
PubMed: 27457694
DOI: 10.1016/j.jep.2016.07.065 -
Pharmaceutical Research Jan 2020We describe the preparation of injectable polymeric paste (IPP) formulations for local and sustained release of drugs. Furthermore, we include the characterization and...
PURPOSE
We describe the preparation of injectable polymeric paste (IPP) formulations for local and sustained release of drugs. Furthermore, we include the characterization and possible applications of such pastes. Particular attention is paid to characteristics relevant to the successful clinical formulation development, such as viscosity, injectability, degradation, drug release, sterilization, stability performance and pharmacokinetics.
METHODS
Paste injectability was characterized using measured viscosity and the Hagen-Poiseuille equation to determine injection forces. Drug degradation, release and formulation stability experiments were performed in vitro and drug levels were quantified using HPLC-UV methods. Pharmacokinetic evaluation of sustained-release lidocaine IPPs used five groups of six rats receiving increasing doses subcutaneously. An anti-cancer formulation was evaluated in a subcutaneous tumor xenograft mouse model.
RESULTS
The viscosity and injectability of IPPs could be controlled by changing the polymeric composition. IPPs demonstrated good long-term stability and tunable drug-release with low systemic exposure in vivo in rats. Preliminary data in a subcutaneous tumor model points to a sustained anticancer effect.
CONCLUSIONS
These IPPs are tunable platforms for local and sustained delivery of drugs and have potential for further clinical development to treat a number of diseases.
Topics: Anilides; Animals; Antineoplastic Agents; Docetaxel; Drug Carriers; Drug Compounding; Drug Liberation; Drug Stability; Humans; Injections; Lidocaine; Male; Mice; Mice, Nude; Neoplasms, Experimental; Nitriles; Ointments; Polylactic Acid-Polyglycolic Acid Copolymer; Prostatic Neoplasms; Rats; Tosyl Compounds; Viscosity
PubMed: 31965346
DOI: 10.1007/s11095-019-2730-4 -
Lancet (London, England) Nov 2020
Topics: Humans; Nitriles; Ointments; Pyrazoles; Pyrimidines; Vitiligo
PubMed: 33248492
DOI: 10.1016/S0140-6736(20)32469-7 -
The Journal of Contemporary Dental... Nov 2017Evaluate in situ the effect of nanohydroxyapatite paste (nano-HAP) before bleaching with hydrogen peroxide 35% (HP35%) by ion chromatography (IC) Knoop hardness number...
AIM
Evaluate in situ the effect of nanohydroxyapatite paste (nano-HAP) before bleaching with hydrogen peroxide 35% (HP35%) by ion chromatography (IC) Knoop hardness number (KHN) and tristimulus colorimetry (TC).
MATERIALS AND METHODS
A total of 60 fragments were obtained from third molars included (3 mm × 3 mm × 3 mm) and the specimens were divided into three groups (n = 20): Gas chromatography (CG) (negative control group) = no bleaching; HP35% (positive control group) = HP35% whitening (whiteness HP35%); nano-HAP = application for 10 minutes before bleaching treatment + HP35%. The specimens were fixed to the volunteers' molars. The KHN and TC were measured before and after bleaching. For IC, the dentin layer was removed, leaving the enamel that was crushed, and autoclaved for chemical quantification (calcium, fluorine, and phosphorus). The results of KHN and TC were analyzed statistically by analysis of variance (ANOVA) followed by Tukey test (p < 0.05).
RESULTS
The HP35% group showed reduction of the Ca, F, and P ions. The initial and final KHN mean of the CG and nano-HAP did not differ statistically; however, the group of HP35% did differ statistically. The mean ΔE of the HP35% and nano-HAP groups did not differ statistically from each other. However, they differed from the CG.
CONCLUSION
The nano-HAP paste preserved the KHN, promoted the lower loss of Ca and P ions and an increase of F ions when compared with the CG, but did not influence the effectiveness of the bleaching treatment.
CLINICAL SIGNIFICANCE
Nano-HA is a biomaterial that has shown positive results in the prevention of deleterious effects on the enamel by the action of the office bleaching treatment.
Topics: Adult; Biocompatible Materials; Dental Enamel; Durapatite; Female; Humans; Male; Nanoparticles; Ointments; Tooth Bleaching Agents; Young Adult
PubMed: 29109310
DOI: 10.5005/jp-journals-10024-2164 -
Journal of Oral Rehabilitation Oct 2014Aim of this study was to quantitatively evaluate the adaptation of the denture base to the mucosa using a non-setting pressure-indicating paste and to examine the...
Aim of this study was to quantitatively evaluate the adaptation of the denture base to the mucosa using a non-setting pressure-indicating paste and to examine the relationship between quality of fit and the need for denture relining. A total of 123 dentures from 70 partially edentulous patients were studied. Examination paste extruded from the tip of the 18-G needle was applied to those denture surfaces contacting the alveolar crest. The denture was manually positioned with all clasps engaged on abutment teeth, and adaptation was assessed through paste distribution. Multiple logistic regression was used to analyse variables associated with diagnosing the need for a denture reline, producing odds ratios and 95% confidence intervals. The spread width was inversely proportional to the gap between the denture and mucosa. Regression analysis revealed statistically significant associations between the need for a denture reline and both the paste spread width and the duration of denture use. According to ROC curve analysis of the 'reline' and 'non-reline' groups, the need for a denture reline was indicated at a paste spread width of 2·0 mm or less. At this 2·0-mm threshold, the sensitivity was 85·1% and the specificity was 75·0%. The fit of removable denture bases was quantitatively evaluated by measuring the spread width of non-setting pressure-indicating paste extruded onto denture fit surfaces. The results suggest that the paste spread width is a useful parameter for discriminating the need for a denture reline.
Topics: Denture, Partial, Removable; Female; Humans; Jaw, Edentulous, Partially; Logistic Models; Male; Ointments; Sensitivity and Specificity; Treatment Outcome
PubMed: 24894573
DOI: 10.1111/joor.12200 -
The Cochrane Database of Systematic... Jan 2020It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg ulcers is directed towards correcting poor arterial blood supply, for example by correcting arterial blockages (either surgically or pharmaceutically). If the blood supply has been restored, these arterial ulcers can heal following principles of good wound-care. Dressings and topical agents make up a part of good wound-care for arterial ulcers, but there are many products available, and it is unclear what impact these have on ulcer healing. This is the third update of a review first published in 2003.
OBJECTIVES
To determine whether topical agents and wound dressings affect healing in arterial ulcers. To compare healing rates and patient-centred outcomes between wound dressings and topical agents.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 28 January 2019.
SELECTION CRITERIA
Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) evaluating dressings and topical agents in the treatment of arterial leg ulcers were eligible for inclusion. We included participants with arterial leg ulcers irrespective of method of diagnosis. Trials that included participants with mixed arterio-venous disease and diabetes were eligible for inclusion if they presented results separately for the different groups. All wound dressings and topical agents were eligible for inclusion in this review. We excluded trials which did not report on at least one of the primary outcomes (time to healing, proportion completely healed, or change in ulcer area).
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted information on the participants' characteristics, the interventions, and outcomes using a standardised data extraction form. Review authors resolved any disagreements through discussion. We presented the data narratively due to differences in the included trials. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, used twice a day by 40 participants with arterial leg ulcers, for eight weeks or until healing, whichever was sooner. One compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life.
AUTHORS' CONCLUSIONS
There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.
Topics: Administration, Topical; Arteries; Bandages, Hydrocolloid; Humans; Leg Ulcer; Occlusive Dressings; Ointments; Randomized Controlled Trials as Topic; Varicose Ulcer; Wound Healing
PubMed: 31978262
DOI: 10.1002/14651858.CD001836.pub4 -
Journal of Ethnopharmacology Oct 2022Psoriasis, despite modern therapeutic options, is incurable and recurrent. In Unani (Greco-Arab) medicine, many medications and formulations have been prescribed by... (Randomized Controlled Trial)
Randomized Controlled Trial
ETHNOPHARMACOLOGICAL RELEVANCE
Psoriasis, despite modern therapeutic options, is incurable and recurrent. In Unani (Greco-Arab) medicine, many medications and formulations have been prescribed by eminent scholars for conditions clinically similar to psoriasis, though empirical evidence is sparse. Hence, the experimental formulations ItrīfalShāhtra and MarhamḤina were chosen to be compared to the standard therapies PUVAsol and petrolatum for their safety and efficacy.
MATERIALS AND METHODS
This open-label, randomized control clinical trial was conducted on 66 male and female participants with chronic plaque psoriasis, ranging in age from 18 to 65 years. In each group, 33 participants were block randomized to either receive Unani formulations or control drugs for 12 weeks. The Unani group received oral Itrīfal Shāhtra (a semisolid paste) and topical MarhamḤina (an ointment) twice daily, and the control group received oral 8-methoxypsoralen and topical petroleum jelly for local application. Participants of both groups were advised to get daily sunlight exposure for 5-15 min. The primary outcome measure was the change in psoriasis area and severity index (PASI) assessed at each visit. Secondary outcome measures were patient global assessment on a 100 mm VAS applied at baseline and after 12 weeks of treatment and change in subjective parameters including erythema, induration, scaling, and itching, assessed on a 5-point scale at every visit. Hemogram, LFTs, RFTs, CXR, ECG, urine, and stool tests were all assessed at baseline and after treatment for the safety of the drugs.
RESULTS
The per-protocol analysis was done on 25 participants in each group. The mean ± SD of the psoriasis area severity index (PASI) significantly decreased from 27.88 ± 12.01 and 23.61 ± 9.79 at baseline to 5.01 ± 4.59 and 9.85 ± 7.16 after completion of the trial therapies in both Unani and control groups, respectively. Also, the test formulations outperformed the control drugs on clinically significant endpoints, PASI 50 and PASI 75, with all 25 participants achieving PASI 50 and 76% achieving PASI 75.
CONCLUSION
The trial formulations, ItrīfalShāhtra and MarhamḤina may be superior to control drugs PUVAsol and petrolatum in terms of safety, efficacy, and tolerability in the treatment of chronic plaque psoriasis. Thus, the Unani formulations may further be evaluated in a well-designed multicentric superiority trial with an adequate sample size.
Topics: Adolescent; Adult; Aged; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Petrolatum; Psoriasis; Severity of Illness Index; Treatment Outcome; Young Adult
PubMed: 35724745
DOI: 10.1016/j.jep.2022.115456 -
Updates in Surgery Dec 2017Myoxinol is a complex of oligopeptides obtained from the seeds of Hibiscus esculentus used in cosmetic as natural alternative to botulin toxin. The aim of the study was... (Clinical Trial)
Clinical Trial
Myoxinol is a complex of oligopeptides obtained from the seeds of Hibiscus esculentus used in cosmetic as natural alternative to botulin toxin. The aim of the study was to evaluate the safety and effectiveness of local myoxinol for the treatment of acute anal fissure. All the consecutive patients with acute fissure treated from January to June 2014 underwent 30 days of topical treatment (twice/day) with a mioxinol based ointment. Pain, symptomatic relief, fissure healing and re-epithelization, 1-year recurrence rate, subjective satisfaction and need for further treatments were evaluated. During the study period 157 patients were eligible for data analysis (91 males: 58%; mean age 38 years: range 17-83). Median anal pain score was 7.1 pre-treatment and 1.7 and 0.9 after 30 days and 12 months from treatment, respectively (p: 0.0001). After the treatment period complete healing was achieved in 103 patients (65.5%), relevant improvement in 31 (20%) and no improvement in 21 patients (13.5%). Overall efficacy rate was 85.5%. A significant difference was reported considering patients with pre-treatment VAS between 1-5 and 6-10 (p: 0.004). Twenty-nine patients (18.5%) required further treatments. Hydrolyzed Hibiscus esculentus extract was proven to be an effective and well-tolerated topical treatment for acute fissure, with a high healing rate, a significant reduction of pain and a low 1-year recurrence rate.
Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Female; Fissure in Ano; Hibiscus; Humans; Male; Middle Aged; Ointments; Phytotherapy; Plant Extracts; Prospective Studies; Seeds; Young Adult
PubMed: 28434175
DOI: 10.1007/s13304-017-0450-z -
The American Journal of Gastroenterology Nov 2020
Topics: Adolescent; Anemia; Diagnosis, Differential; Gastrointestinal Hemorrhage; Granuloma; Humans; Male; Ointments; Rectal Neoplasms
PubMed: 33156089
DOI: 10.14309/ajg.0000000000000776