Publications by authors named "Polonini H"

Objective: This study evaluates the physicochemical compatibility of six active pharmaceutical ingredients (APIs) - 17-a-estradiol, betamethasone, finasteride, melatonin, prednicarbate, and spironolactone - in TrichoFoam™, a foaming vehicle designed for personalized alopecia treatments.

Background: Alopecia, a condition impacting around 2% of the global population, can benefit from more effective and patient-friendly treatments. TrichoFoam™ represents a personalized medicine approach that utilizes a foam base to enhance the delivery and efficacy of topical treatments.

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Compounding pharmacies commonly use ready-to-use vehicles such as TrichoSolTM to produce hair solutions for alopecia. However, chemical and microbiological compatibility are paramount to be determined so those can be safely implemented as the vehicle of choice. This study aimed to assess the physical-chemical and microbiological stabilities of selected active pharmaceutical ingredients in TrichoSolTM.

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Article Synopsis
  • The study analyzes the stability and compatibility of active pharmaceutical ingredients in Cleoderm™, a cream aimed at treating various skin conditions like acne and dermatitis.
  • Advanced methods like high-performance liquid chromatography (HPLC) were used to ensure that the ingredients maintain their efficacy under stress.
  • Results showed that key ingredients remained stable over a designated shelf life of 180 days, confirming Cleoderm™ as a reliable option for customized dermatological therapies.
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Alopecia is a chronic dermatological disorder that affects patients worldwide, with a significant impact on quality of life, self-esteem, and psychological wellbeing. However, commercially available options for alopecia treatment are still limited. Considering that topical formulations have a long-term use therapeutic profile, the safety of their ingredients should be closely evaluated to avoid potentially irritant substances.

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Background: Alopecia is a chronic dermatological disorder affecting men and women worldwide. Given the high incidence and significant impact on patients' well-being, options for managing and treating alopecia are essential. Topical available options remain limited and oral products may result in adverse effects.

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Orodispersible films (ODFs) are solid pharmaceutical forms for rapid local or systemic release of active ingredients. They are formed by a water-soluble polymer film that hydrates rapidly, adhering and dissolving immediately when placed on the tongue or in the oral cavity. In this paper, we describe the compatibility and disintegration times of compounded ODFs using OrPhyllo, a new ready-to-use-vehicle, and APIs from different pharmacological classes, such as 5-hydroxytryptophan (5-HTP) 50 mg, bromopride 5 mg, coenzyme Q10 20 mg, melatonin 3 mg, resveratrol 5 mg, tadalafil 10 mg, vitamin B12 1 mg, or vitamin D3 2000 UI.

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The present study aimed to evaluate the stability of active pharmaceutical ingredients (APIs) from different pharmacological classes in a compounded oral suspending vehicle. Oral suspensions of amoxicillin trihydrate (50 mg/mL), clozapine (25 mg/mL), indomethacin (5.0 mg/mL), levodopa/carbidopa (10.

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Background: Allergic asthma is a chronic lung disease in which the lung inflammation and airway remodeling are orchestrated by both the inflammatory and the immune cells that creates a lung millieu that favors the perpetuation of clinical symptoms. The cell signaling in asthma involves the mast cells activation during initial contact with the allergen and, principally, the participation of eosinophils as well as Th2 cells which determine increased levels of IgE, exaggerated secretion of mucus and collagen, and bronchial hyperreactivity. Moreover, allergic asthma presents lower level of cytokines associated to the both Th1 and Treg cells response, and it implies in deficiency of anti-inflammatory response to counterregulate the exaggerated inflammation against allergen.

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Airborne infectious diseases have been a major worldwide concern for many years. The sudden and fast spread of the severe acute respiratory syndrome 2, causing the coronavirus disease 2019 in a pandemic form, has intensified the necessity of constant environmental disinfection. Among the possible technologies that can be used for air disinfection is the ultraviolet germicidal irradiation through the use of ultraviolet C light.

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The development of an efficient formulation for hardshell capsules needs to consider pharmaceutical and biopharmaceutical aspects to assist in the careful selection of excipients, which are essential ingredients for the formulation's good performance. They ensure correct bioavailability, solubility, stability, dose accuracy (weight variation and content uniformity), and organoleptic characteristics. Given this, DiluCap was developed as a line of excipients so that the pharmacist can compound every capsule formulation with ease and trust in its final characteristics.

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Endometriosis presents high prevalence and its physiopathology involves hyperactivation of endometrial and vaginal cells, especially by bacteria. The disease has no cure and therapies aiming to inhibit its development are highly desirable. Therefore, this study investigated whether Miodesin (10 µg/mL = IC; 200 µg/mL = IC), a natural compound constituted by , , and astaxanthin, could exert anti-inflammatory and anti-proliferative effects against Lipopolysaccharides (LPS) stimulation in endometrial and vaginal cell lines.

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Transdermal products are intended to be applied topically but to promote the biological effects systemically, while transmucosal products have the same final effect but are to be applied on mucosa (for example, vaginal mucosa). The extension and velocity in which absorption occurs vary depending on the vehicle used, the active pharmaceutical ingredient and a broad range of other factors related to the formulation, patient, and environmental characteristics. Ready-to-use vehicles, such as Pentravan, with proven penetration efficacy for various active pharmaceutical ingredients, are paramount.

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In this work, we focus on three ready-to-use vehicles: Fitalite, Versatile, and HRT Supreme Cream Base. Fitalite is a natural, light, hydrophilic gel-cream that contains vitamin E and oil bodies from plant sources (phytosomes), providing antioxidant and skinmoisturizing properties. Versatile is a vanishing oil-inwater cream base which retains its consistency with a broad range and high concentrations of active pharmaceutical ingredients, dermaceutical ingredients, and solvents.

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Objective: Develop and assess a transdermal emulsion loaded with nanostructured lipid carriers for vitamin D supplementation.

Methods: Vitamin D loaded nanostructured lipid carriers, produced via high shear homogenization and ultrasonication, were assessed for their particle size, distribution, morphology, zeta potential, entrapment efficiency, and cytotoxicity. They were incorporated into a transdermal vehicle, and the stability and ex vivo permeation were evaluated.

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Imuno TF is a nutritional supplement composed of isolated transfer factors (TF) from porcine spleen. It is composed of a specific mixture of molecules that impact functions of the biological systems and historically is linked to the immune system regulation. In this study, we demonstrate for the first time its proteomic analysis, nutritional composition, and safety profile in terms of mutagenic potential and acute oral dose (LD).

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The mixing process plays a pivotal role in the quality of pharmaceuticals and food/dietary supplements, as it can impact the homogeneity of the substances in their dosage form and affect characteristics such as dissolution and stability. Thus, the choice of the right mixing device is paramount for compounding pharmacies. In this paper, we evaluated the mixing efficacy of a new 3-axis mixer device and determined its optimal working conditions.

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Compounded medicinal products should be prepared using an appropriate quality-assurance system. Cleaning and disinfection, as part of this system, are important to avoid cross-contamination of the preparations, reduce the bioburden levels in products, and avoid hazardous drugs residues or toxic chemical exposure of the staff workers. However, manual cleaning is difficult to standardize.

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There is still an evident need for nonsterile compounded medications for pediatric and elderly patients in cases where patients require dose adjustments or have swallowing difficulties. Pharmacists generally have the choice between compounding capsules or oral liquids. In daily pharmacy practice, extemporaneous capsules are from time to time seen as a better alternative to oral liquid medication, although various published studies indicate that weight variation and/or uniformity of content can be significantly out of specification for compounded capsules.

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The number of COVID-19 patients is still growing exponentially worldwide due to the high transmissibility of the SARS-CoV-2 virus. Therapeutic agents currently under investigation are antiviral drugs, vaccines, and other adjuvants that could relieve symptoms or improve the healing process. In this review, twelve therapeutic agents that could play a role in prophylaxis or improvement of the COVID-19-associated symptoms (as add-on substances) are discussed.

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To allow for tailored dosing and overcome swallowing difficulties, compounded liquid medication is often required in pediatric patients. The objective of this study was to evaluate the stability of oral suspensions compounded with SyrSpend SF PH4 and the commonly used active pharmaceutical ingredients azathioprine (powder) 50 mg/mL, azathioprine (from tablets) 50 mg/mL, clonidine hydrochloride (powder) 0.1 mg/mL, clopidogrel bisulfate (from tablets) 5 mg/mL, ethambutol hydrochloride (powder) 50 mg/mL, ethambutol hydrochloride (from tablets) 50 mg/mL, ethambutol hydrochloride (powder) 100 mg/mL, griseofulvin (powder) 25 mg/mL, hydralazine hydrochloride (powder) 4 mg/mL, nitrofurantoin (powder) 10 mg/mL, and thioguanine (powder) 2.

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Objective: Organic silicon has been linked to positive effects on the skin rejuvenation, mainly by the oral route. Thus, the main objective of the present study was to assess whether monomethylsilanetriol (MMST, a source of organic silicon) can deliver silicon to the epidermis and dermis, when applied topically in a cream. Once the hypothesis was confirmed, the present study also evaluated whether the product was toxic to keratinocytes; additionally, its possible antioxidant activity was assessed.

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Objectives: To evaluate the microbiological and physicochemical compatibility of commonly used proton pump inhibitors (PPIs) esomeprazole, lansoprazole, omeprazole and pantoprazole compounded at a single concentration using SyrSpend SF Alka and stored at refrigerated temperatures (omeprazole was also stored at room temperature because it has the most widespread use).

Methods: Compatibility was assessed by measuring the per cent recovery at varying time points throughout a 90-day period. Quantification of the APIs was performed by a validated high performance liquid chromatography (HPLC-UV) method.

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There are a substantial amount of suppliers for roller mills in the market, but there is a lack of scientific evidence of a roller mill's capacity to improve particle size reduction/distribution or homogenization. In this concise paper, we evaluate the use a roller mill in the final steps of compounding semisolid dosage forms. We performed three simple tests to verify these claims: 1) particle size evaluation through dynamic light scattering and scanning electron microscopy techniques, 2) content uniformity through high-performance liquid chromatography technique, and 3) cross contamination through a cleaning validation method.

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The purpose of this study was to evaluate the transmucosal permeation of progesterone and testosterone using Pentravan as its vehicle for vaginal delivery. Progesterone deficiency is a hormone imbalance that could lead to luteal-phase deficiency, which is a common problem in assisted reproductive technologies. Testosterone has been explored for treating postmenopausal symptoms, such as vaginal atrophy.

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Metformin hydrochloride is a traditional, FDA-approved drug used as a first-line drug of choice to treat type 2 diabetes. Research has shown metformin hydrochloride effective in injuries, including age-related maladies. The purpose of this ex vivo study was to evaluate the use of a commercial transdermal vehicle as a semisolid, liposomal vanishing cream (Pentravan) to deliver metformin hydrochloride through the human skin.

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