Compatibility of Caffeine Clobetasol Propionate Dutasteride Nicotinamide and Progesterone in TrichoFoam™, a Natural Vehicle for Hair Foams.

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. TrichoFoam™ is a ready-to-use foaming vehicle developed for compounding pharmacies and formulated with gentle, non-irritating, and sensory-pleasant ingredients. OBJECTIVE: The purpose of this study was to assess topical foams' physicochemical and microbiological stabilities of formulations compounded with TrichoFoam™ as the ready-touse vehicle. METHODS: HPLC analyses were conducted in a bracketed study covering concentrations of 0.1% to 2.0% of caffeine, 0.01% to 0.1% of clobetasol propionate, 0.1% to 0.25% of dutasteride, 0.25% to 0.50% of nicotinamide, and 0.25% to 2.5% of progesterone compounded with TrichoFoam™. Antimicrobial Effectiveness Testing was conducted at the beginning and end of the studies. RESULTS: Most formulations presented a beyond-use date of at least 90-180 days, except for clobetasol propionate, which showed compatibility for 14 days, and dutasteride 0.25%, which showed a BUD of 30 days. CONCLUSION: This validates the stability of the active pharmaceutical ingredients from different pharmacological classes with TrichoFoam™, suggesting that this ready-to-use vehicle can be an excellent alternative for personalized alopecia treatment.

Clinical Safety Profile of TrichoConcept™, a Line of Cosmetic Vehicles for Personalized Treatment of Alopecia.

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. Alternative active ingredients with different mechanisms of action, as well as adequate vehicles, might increase patients' adherence leading to better clinical outcomes. The purpose of this study was to examine the irritation, skin sensitization, photoallergy, and phototoxicity potential of a line of ready-to-use vehicles for producing topical therapies for alopecia treatments, TrichoConcept™. Subjects were selected and randomly assigned to compare the patch test with the study products or to the control solution (sterile 0.9% NaCl solution). No clinical signs of irritation, sensitization, photoallergy or phototoxicity were reported. From the results of this study, it is suggested that the investigated products can be considered safe under the evaluated conditions, and the claims "dermatologically tested", "clinically tested", and "nonirritant" can be supported.

Utilising SNP Association Analysis as a Prospective Approach for Personalising Androgenetic Alopecia Treatment.

INTRODUCTION: Androgenetic alopecia (AGA) is a prevalent, multifactorial form of hair loss involving complex aetiological factors, such as altered androgen regulation and energy metabolism. Existing treatments offer limited success, thus highlighting the need for advanced, personalised therapeutic strategies. This study focuses on correlating the genetic mechanisms of AGA with molecular targets involved in the response to current treatment modalities. METHODS: An anonymised database including 26,607 patients was subjected to analysis. The dataset included information on patients' genotypes in 26 single nucleotide polymorphisms (SNPs), specifically, and diagnosed AGA grades, representing a broad range of ethnic backgrounds. RESULTS: In our sample, 64.6% of males and 35.4% of females were diagnosed with female pattern hair loss. This distribution aligns well with prior studies, thus validating the representativeness of our dataset. AGA grading was classified using the Hamilton-Norwood and Ludwig scales, although no association was found to the grade of the disease. SNP association analysis revealed eight SNPs, namely rs13283456 (PTGES2), rs523349 (SRD5A2), rs1800012 (COL1A1), rs4343 (ACE), rs10782665 (PTGFR), rs533116 (PTGDR2), rs12724719 (CRABP2) and rs545659 (PTGDR2), to be statistically significant with a p-value below 0.05. CONCLUSIONS: The study establishes a preliminary association between eight specific SNPs and AGA. These genetic markers offer insights into the variability of therapeutic responses, thus underlining the importance of personalised treatment approaches. Our findings show the potential for more targeted research to understand these SNPs' and further roles in AGA pathophysiology and in modulating treatment response.

Compatibility Assessment of Novel Orodispersible Film Vehicle for Personalized Medicine with Selected Active Pharmaceutical Ingredients.

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 OrPhylloTM, 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. ODFs were compounded and, subsequently, the samples were assayed using HPLC at initial (t = 0), 7 days (t = 7), 14 days (t = 14), 30 days (t = 30), 60 days (t = 60), 90 days (t = 90), 120 days (t = 120), 150 days (t = 150), and 180 days (t = 180) after compounding. Given the percentage of recovery of the APIs within the films, the beyond-use date of the final products (API + vehicle) was at least 90 days for vitamin D3, 150 days for bromopride and 5-HTP, and 180 days for coenzyme Q10, tadalafil, vitamin B12, resveratrol, and melatonin, when stored at room temperature. The average disintegration time was 46.22 s. This suggests that the OrPhylloTM vehicle is suitable for compounding ODFs with APIs from different pharmacological classes, with good compatibility and fast disintegration.

Compatibility of Commonly Used Active Pharmaceutical Ingredients in a Ready-to-Use Oral Suspending Vehicle.

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 (10.0/2.5 mg/mL), levothyroxine sodium (T4, 25 µg/mL), lomustine (4.0 and 10.0 mg/mL), methyldopa (25 mg/mL) and procarbazine (10.0 mg/mL) were formulated in SyrSpend® SF PH4 and the stability was monitored for up to 90 days, except for amoxicillin trihydrate, which was evaluated for 30 days only. The APIs' stability was determined by measuring percent recovery using stability-indicating high-performance liquid chromatography (HPLC or UHPLC) or titration (amoxicillin trihydrate only). The stability of amoxicillin trihydrate, clozapine, indomethacin and levodopa/carbidopa were studied at both refrigerated (2-8 °C) and room temperature (20-25 °C). Lomustine, procarbazine, and methyldopa were studied at refrigerated temperature only. Our data demonstrated promising stability for the compounded suspensions containing various APIs, investigated in SyrSpend® SF PH4, as all APIs exhibited stability throughout the study duration and met content uniformity criteria. These findings lead to the conclusion that the tested compounded oral suspensions present a viable approach for creating personalized, age-appropriate formulations. The capacity to ensure dose consistency and stability using APIs from diverse pharmacological classes renders them suitable choices for both pediatric and geriatric patients.

Effectiveness of a New Ultraviolet C Disinfection System to Inactivate Airborne Coronavirus in Different Environmental Conditions.

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. The main mechanism involved in ultraviolet C light inactivation of microorganisms such as viruses, bacteria, protozoa, fungi, yeasts, and others is mainly due to its capacity to promote dimerization of pyrimidine, disturbing the microorganism's DNA (and RNA) replication and transcription, therefore leading to cell death. The aim of this study was to validate the efficacy of a new ultraviolet C light disinfection system to deactivate viruses such as coronavirus in different environmental conditions. The device was effective in the neutralization of airborne particles containing coronavirus genus samples, presenting >99.99% of inactivation rate in an aerosolization test, simulating the real conditions in which this virus is most transmitted in different environments.

Evaluation of the Physical-chemical Characteristics and Biopharmaceutical Performance of Dilu-Cap: A Complete Line of Excipients for Hard-shell Capsules.

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. The line is composed of six excipients: 1) Dilucap SLD, for soluble active pharmaceutical ingredients Class I and III from the Biopharmaceutical Classification System - it promotes disintegration without a negative impact on dissolution; 2) Dilucap PSD, for poorly soluble active pharmaceutical ingredients Class II and IV - it favors the disintegration and dissolution of the active pharmaceutical ingredients; 3) Dilucap SR, for active pharmaceutical ingredients requiring modified/ slow release - it reduces the disintegration and release rate of the active pharmaceutical ingredients, promoting its slow release, and, also, prevents plasma peaks responsible for adverse effects; 4) DiluCap Hygro, for hygroscopic or deliquescent active pharmaceutical ingredients - it reduces hygroscopicity, deliquescence, and eutectic mixture formation; 5) DiluCap Antioxi, for active pharmaceutical ingredients susceptible to oxidation - it provides chemical stabilization due to antioxidant ingredients and reduces water activity and chemical degradation; 6) DiluCap OD, for orodispersible active pharmaceutical ingredients that can be compounded as sprinkle capsules or sublingual capsules - it favors transmucosal permeation. The testing conducted for the DiluCap line of excipients showed that all products have suitable flow properties (angle of repose and Carr's compressibility index), hygroscopicity, biopharmaceutical performance (dissolution profiles), and stability. This corroborates the allegations that DiluCap provides a science based line of excipients to the compounding pharmacies with proven functionality that saves time (reduces the preprocessing and the number of items in stock) and guarantees efficacy and safety of hard-shell oral capsules formulations.

MiodesinTM Positively Modulates the Immune Response in Endometrial and Vaginal Cells.

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 MiodesinTM (10 µg/mL = IC80; 200 µg/mL = IC50), a natural compound constituted by Uncaria tomentosa, Endopleura uchi, and astaxanthin, could exert anti-inflammatory and anti-proliferative effects against Lipopolysaccharides (LPS) stimulation in endometrial and Candida albicans vaginal cell lines. VK2 E6/E7 (vaginal) and KLE (epithelial) cell lines were stimulated with Candida albicans (1 × 107 to 5 × 107/mL) and LPS (1 µg/mL), respectively. MiodesinTM inhibited mRNA expression for Nuclear factor kappa B (NF-κB), ciclo-oxigenase 1 (COX-1), and phospholipase A2 (PLA2), beyond the C-C motif chemokine ligand 2 (CCL2), CCL3, and CCL5 in VK2 E6/E7 cells (p < 0.05). In addition, the inhibitory effects of both doses of MiodesinTM (10 µg/mL and 200 µg/mL) resulted in reduced secretion of interleukin-1ß (IL-1ß), IL-6, IL-8, tumor necrosis factor α (TNF-α) (24 h, 48 h, and 72 h) and CCL2, CCL3, and CLL5 (p < 0.05) by VK2 E6/E7 cells. In the same way, COX-1 MiodesinTM inhibited LPS-induced hyperactivation of KLE cells, as demonstrated by reduced secretion of IL-1ß, IL-6, IL-8, TNF-α (24 h, 48 h, and 72 h) and CCL2, CCL3, and CLL5 (p < 0.05). Furthermore, MiodesinTM also inhibited mRNA expression and secretion of matrix metalloproteinase-2 (MMP-2), MMP-9, and vascular endothelial growth factor (VEGF), which are key regulators of invasion of endometrial cells. Thus, the study concludes that MiodesinTM presents beneficial effects in the context of endometriosis, positively affecting the inflammatory and proliferative response.

Transfer factors peptides (Imuno TF®) modulate the lung inflammation and airway remodeling in allergic asthma.

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. Therefore, the equilibrium between cytokines as well as transcription factors associated to Th2, Th1, and Treg cells is compromised in allergic asthma. Imuno TF® is a food supplement with ability to interfere in immune system pathways. It has been previously demonstrated that Imuno TF® upregulated Th1 cell response whilst downregulated Th2 cell response in human lymphocytes. Objective: For this reason, we hypothesized that the Imuno TF effect could be restore the balance between Th1/Th2 CD4 T cells response in murine allergic asthma. Methods: Initially, animals were sensitized with OVA via i.p. and challenged with OVA i.n. on days 14, 15 and 16. Treatment with Imuno TF once a day was performed via orogastric from day 17 to day 20. Mice were euthanized on day 21. Results: The Imuno TF reduced eosinophilia, mucus production, and airway remodeling (collagen deposition) in asthma mice. Imuno TF influenced cellular signaling associated to allergic asthma once downregulated STAT6 expression as well as decreased IL-4, IL-5, and IL-13 in lung and serum. In addition, Imuno TF restored T-bet and Foxp3 expression as well as increased IL-12, IFN-É£, and IL-10. Conclusion: Ultimately, Imuno TF mitigated the allergic asthma due to the restoration of balance between the responses of Th1/Th2 as well as Treg cells, and their respective transcription factors the T-bet/STAT6 and Foxp3.

Assessment of a Novel Vitamin D3 Formulation with Nanostructured Lipid Carriers for Transdermal Delivery.

OBJECTIVE: Develop and assess a transdermal emulsion loaded with nanostructured lipid carriers for vitamin D3 supplementation. METHODS: Vitamin D3 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. RESULTS: Spherical nanoparticles were developed with a particle size of 192.5 nm, a polydispersity index of 0.13, a zeta potential of -29.0 mV, and an entrapment efficiency of 99.75%. They were stable (particle size and distribution) for 15 days when stored in a refrigerator, and for 30 days at room temperature and 32°C. The nanoparticles decreased the drug cytotoxicity against fibroblasts, as shown by IC50 (nanoparticle: 32.48 µg mL-1 vitamin D3: 16.73 µg mL-1). The emulsion loaded with nanoparticles minimized the degradation of vitamin D3 when compared with the nanoparticle dispersion. Additionally, the emulsion provided the skin permeation of vitamin D3 following the recommended daily allowance. CONCLUSION: To the best of our knowledge, this is the first study to use nanostructured lipid carriers for transdermal delivery of vitamin D. The developed formulation is a promising strategy to overcome the vitamin D3 variable oral bioavailability. It also represents a comfortable route of administration; thus it could be beneficial for patients and clinicians. However, further studies are needed to allow the permeation of larger amounts of vitamin D3, and the combination of these nanoparticles with microneedles would be interesting.

Compatibility of Gestrinone, Nimesulide, and Piroxicam in Pentravan for Transdermal and Transmucosal Application.

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. Pentravan, specially developed for compounding pharmacies, has been extensively studied. To date, most studies have focused on endocrinology (e.g., sexual hormones), anti-aging strategies, and gynecology (endometriosis and related conditions). In this work, we have determined the compatibility of Pentravan and three active pharmaceutical ingredients: gestrinone, a steroidal substance for vaginal use (endometriosis), and nimesulide and piroxicam, two nonsteroidal anti-inflammatory drugs used both for topical and vaginal application. This article shows an excellent beyond-use date of 180 days when stored at room temperature, which renders it suitable for daily practice.

Compatibility of Estradiol, Estriol, Estrone, Progesterone, and Testosterone Single Formulation in Fitalite, Versatile, or HRT Supreme Cream Base.

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. Finally, HRT Supreme Cream Base is a paraben-free, dye-free, fragrance-free O/W emulsion base, formulated with a complex of botanical oils to soothe and provide moisture to dry and sensitive skin. In the current study, we evaluated the beyond-use date of formulations containing estradiol, estriol, estrone, progesterone, and testosterone in combination, compounded with these three vehicles. Validated, stability-indicating high-performance liquid chromatography methods were used throughout a 180-day period. A beyond-use date of 180 days was observed for all vehicles stored both at refrigerated and at room temperature. The combination of five ingredients represents a worst-case scenario since there are more possibilities of cross reactions. Therefore, we expect the same or greater stability as individual ingredients are removed from the tested formulation. The extended beyond-use dates provide convenience for both the compounding pharmacist and the patient.

Characterization and Safety Profile of Transfer Factors Peptides, a Nutritional Supplement for Immune System Regulation.

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 (LD50). The obtained analysis indicated the product is a complex set of oligo- and polypeptides constituted of 163 different peptides which can potentially act on multiple mechanisms on the immune system pathways. The chemical composition showed low fat and low sugar content, saturated fatty acids-free, and the presence of 10 vitamins and 11 minerals. No mutagenic effect was observed, and the LD50 was 5000 mg kg-1 body weight. This accounts for a safe product to be used by the oral route, with potential benefits for the immune system.

Ensuring Homogeneity in Powder Mixtures for Pharmaceuticals and Dietary Supplements: Evaluation of a 3-Axis Mixing Equipment.

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. Three different formulations were compounded with the device and a total of 540 individual assays were performed by HPLC or ICP-MS to validate its use, in addition to a direct comparison among it and two alternative mixing methods. The 3-axis mixer device was able to provide homogeneous mixtures and finished capsules with adequate content uniformity with a broad range of conditions of use (mixing times from 2 to 8 min, and speed of rotation from 10 to 100 rpm). In addition, the device was superior to classical mixing methods (such as the use of manually shaken plastic bags) and at least equivalent to well-established ones (Y-shaped mixer). Finally, we proposed a cleaning procedure that was also adequate to prevent cross-contamination among products compounded with the same device.

Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested.

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. In contrast, analyses with the ready-to-use oral liquid vehicle SyrSpend SF in 104 different formulations with 89 unique active pharmaceutical ingredients showed results that all 6.414 samples analyzed were within specification. It can, therefore, be argued that SyrSpend SF could be a better way to assure content uniformity compared to manually compounded, small-batch extemporaneous capsules.

Efficacy of an Automated Robotic Cleaning Device for Compounding Pharmacies.

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. Automated robotic cleaning devices are currently available and designed for domestic use only. To fill this gap, a laboratory automated robotic cleaning device (RVC1, FagronLab, The Netherlands) was specially developed to clean and sanitize laboratories of compounding pharmacies and other production facilities of primary healthcare establishments. The objective of this study was to evaluate the efficacy of an automated robotic cleaning device (robotic vacuum cleaner) for compounding pharmacies and other production facilities of primary healthcare establishments. A set of 6 experiments was conducted to evaluate the efficacy of the cleaning procedure using the automated robotic cleaning device. All experiments were conducted at the end of a regular daily routine in the laboratory to simulate a genuine cleaning procedure. Tests were performed both with no forced contamination (to imitate the regular use of the device) and with forced contamination (to mimic unexpected, non-regular contamination, such as in the case of accidents). Total aerobic microbial count and the total combined yeasts and molds count were determined, as well as pathogens identification and the concentration of thiamine hydrochloride and progesterone active pharmaceutical ingredients (deliberately spread on the floor surface for the tests). In real-conditions, both two-step and single-step were adequate to clean the areas and reduce microbiological contamination to non-detected levels, and only the cleaning cycle without the mopping accessory was also suitable (in the two-step cleaning). The same can be seen for the forced-contamination condition, except for the use of the cleaning cycle without the mopping. In terms of chemical contamination, both high and low water-soluble active pharmaceutical ingredients were reduced (completely and 932-fold, respectively) in the single-step cleaning. The RVC1 automated robotic cleaning device showed the necessary microbiological and chemical efficacy to be used in the cleaning routine of compounding pharmacies, both in a singlestep cleaning (brushing, ultraviolet light, and mopping simultaneously) or in a double-step cleaning (brushing and ultraviolet light first, mopping second). It is then recommended to always use the mopping accessory and the ultraviolet light on. The RVC1 can be a valuable add-on method to standardize cleaning.

Postulated Adjuvant Therapeutic Strategies for COVID-19.

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. Agents were identified based on their known pharmacologic mechanism of action in viral and/or nonviral fields and are postulated to interact with one or more of the seven known mechanisms associated with the SARS-CoV-2 virus: (i) regulation of the immune system; (ii) virus entrance in the cell; (iii) virus replication; (iv) hyperinflammation; (v) oxidative stress; (vi) thrombosis; and (vii) endotheliitis. Selected agents were immune transfer factor (oligo- and polypeptides from porcine spleen, ultrafiltered at <10 kDa; Imuno TF®), anti-inflammatory natural blend (Uncaria tomentosa, Endopleura uchi and Haematoccocus pluvialis; Miodesin®), zinc, selenium, ascorbic acid, cholecalciferol, ferulic acid, spirulina, N-acetylcysteine, glucosamine sulfate potassium hydrochloride, trans-resveratrol, and maltodextrin-stabilized orthosilicic acid (SiliciuMax®). This review gives the scientific background on the hypothesis that these therapeutic agents can act in synergy in the prevention and improvement of COVID-19-associated symptoms.

Stability of Azathioprine, Clonidine Hydrochloride, Clopidogrel Bisulfate, Ethambutol Hydrochloride, Griseofulvin, Hydralazine Hydrochloride, Nitrofurantoin, and Thioguanine Oral Suspensions Compounded with SyrSpend SF pH4.

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) 2.5 mg/mL. Suspensions were compounded at the concentrations listed above and stored at controlled room and refrigerated temperatures. Stability was assessed by measuring the percentage recovery at 0 day (baseline), and at 7 days, 14 days, 30 days, 60 days, and 90 days. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography, via a stability-indicating method. The following oral suspensions compounded using SyrSpend SF PH4 as the vehicle showed a beyond-use date of 90 days when stored both at room or refrigerated temperatures: clonidine hydrochloride 0.1 mg/mL, ethambutol hydrochloride 50 mg/mL and 100 mg/mL, griseofulvin 25 mg/mL, nitrofurantoin 10 mg/mL, and thioguanine 2.5 mg/mL, all compounded from the active pharmaceutical ingredients in powder form. Suspensions compounded using the active pharmaceutical ingredients from tablets presented a lower beyond-use date: 30 days for ethambutol hydrochloride 50 mg/mL and hydralazine hydrochloride 4 mg/mL, stored at both temperatures, and for clopidogrel bisulfate 5 mg/mL when stored only at refrigerated temperature. Azathioprine suspensions showed a beyond-use date of 14 days when compounded using active pharmaceutical ingredients in powder form at both temperatures. This suggests that SyrSpend SF PH4 is suitable for compounding active pharmaceutical ingredients from different pharmacological classes.

Towards the Importance of a Roller Mill in Compounding Practice: An Experimental Approach.

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. Dynamic light scattering and scanning electron microscopy techniques of benzoyl peroxide 5% (gel) and testosterone 1% (cream) showed a significant reduction on particle diameter. Content uniformity testing of creams containing progesterone 5%, estradiol 0.1%, and estriol 0.4% showed better homogeneity when using the roller mill. Finally, the proposed cleaning procedure decreased the presence of the compounded preparation to a "none-detection" level after the procedure. This suggests that the roller mill used does, in fact, play a role in the final aspect and quality of pharmaceutical semisolid dosage forms.

Transdermal Delivery of Metformin Hydrochloride from a Semisolid Vehicle.

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. The experiments were conducted as percutaneous absorption assay in Franz Diffusion Cells, coupled with freshly excised human skin and analyzed by high-performance liquid chromatography. Both methods were based on validated methods of both the United States Pharmacopeial Convention, Inc. and the International Conference on Harmonization. A 46.7% permeation percentage was found, with a drug flux of 3.91 µg cm-2 h-1 and a lag time of 0.51 h, following pseudo first-order absorption kinetics. These results showed that transdermal metformin hydrochloride can be an option for patients searching for diverse clinical effects.