[Research strategy for homogenization feeding of Chinese patent medicines].

Chinese patent medicine constitutes a vital segment of the traditional Chinese medicine(TCM) industry and stands as a significant emblem of TCM modernization. At present, the quality stability between batches of Chinese patent medicine preparations has become a pivotal factor directly restricting the high-quality development of the TCM industry. Consequently, addressing the homogeneity of Chinese patent medicines, this paper proposes a research scheme of homogenization feeding. It systematically elaborates on the object and pretreatment of homogenization, operational procedures of homogenization feeding, selection of homogenization evaluation indices, homogenization feeding algorithm, and homogenization feeding process. With the key quality control indicators as the homogenization target, the homogenization feeding process and its quality analysis were discussed. Finally, a demonstration strategy for homogenization feeding of Chinese patent medicine was formed, providing the scientific basis for advancing the research of quality consistency across batches of Chinese patent medicine preparations.

Development and Validation of an HPLC Method for Simultaneous Determination of Capsaicinoids and Camphor in Over-the-Counter Medication for Topical Use.

A reverse-phase high-performance liquid chromatography method was developed to determine and quantify capsaicin (trans-8-methyl-N-vanillyl-6- nonenamid), dihydrocapsaicin (8-methyl-N-vanillylnonanamide), and camphor (trimethylbicyclo[2.2.1]heptan-2-one). It is applicable in analyses of over-the-counter (OTC) medications for topical use and raw materials such as chili pepper oleoresin. Chromatographic separation was carried out on a C18 column using an isocratic flow of the mobile phase containing acetonitrile and ultrapure water in a ratio of 2:3, with pH adjusted to 3.2 using glacial acetic acid, and a flow rate of 1.5 mL/min. The concentration of the eluting compounds was monitored by a diode-array detector at a wavelength of 281 nm. The method was evaluated for several validation parameters, including selectivity, accuracy (confidence intervals < 0.05%), repeatability, and intermediate precision. The limit of detection (LOD) was determined to be 0.070 µg/mL for capsaicin, 0.211 µg/mL for dihydrocapsaicin, and 0.060 µg/mL for camphor. The limit of quantification (LOQ) was determined to be 0.212 µg/mL for capsaicin, 0.640 µg/mL for dihydrocapsaicin, and 0.320 µg/mL for camphor. Linearity was set in the range of 2.5-200 µg/mL for capsaicin and dihydrocapsaicin and 25-2000 µg/mL for camphor. The suggested analytical method can be used for quality control of formulated pharmaceutical products containing capsaicinoids, camphor, and propolis.

Discovery of minor quality evaluation marker compounds for Chinese patent medicine products using a two-leveled metabolomics strategy.

Chinese patent medicines (CPMs) are popularly used in clinical practice. Though the composition is complex, the quality of CPM is usually evaluated by the contents of a few main compounds. In this study, a two-leveled metabolomics strategy was proposed to discover minor marker compounds for different CPM products. Zhenqi Fuzheng (ZQFZ) granule was studied an example, where 15 batches from 3 producers were analyzed. The samples were separated using UHPLC on an Acquity UPLC® HSS T3 column, and then detected using Q-Orbitrap-MS. In the first level, 1475 common peaks were extracted and 95 compounds were identified using diagnostic ions and a homemade database. In the second level, the data were subjected to a two-way hierarchical clustering analysis and screened by variable importance value. In total 14 marker compounds were discovered which were responsible for the grouping of different ZQFZ products. Echinacoside (22), oleoside (13), loganic acid (5), salidroside (7), ligustrosidic acid (42), 6α-hydroxygeniposide (28), and oleoside 11-methyl ester (15) could be used to reflect the quality difference for ZQFZ granule products. The proposed strategy could also contribute to the discovery of quality control markers for other CPMs.

Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging.

Agglomeration of active pharmaceutical ingredients (API) in tablets can lead to decreased bioavailability in some enabling formulations. In a previous study, we determined that crystalline APIs can be detected as agglomeration in tablets formulated with amorphous acetaminophen tablets. Multiple method advancements are presented to better resolve agglomeration caused by crystallinity in standard tablets. In this study, we also evaluate three "budget" over-the-counter headache medications (subsequently labeled as brands A, B, and C) for agglomeration of the three APIs in the formulation: Acetaminophen, aspirin, and caffeine. Electrospray laser desorption ionization mass spectrometry imaging (ELDI-MSI) was used to diagnose agglomeration in the tablets by creating molecular images and observing the spatial distributions of the APIs. Brand A had virtually no agglomeration or clustering of the active ingredients. Brand B had extensive clustering of aspirin and caffeine, but acetaminophen was observed in near equal abundance across the tablet. Brand C also had extensive clustering of aspirin and caffeine, and minor clustering of acetaminophen. These results show that agglomeration with active ingredients in over-the-counter tablets can be simultaneously detected using ELDI-MS imaging.

Pharmacological Aspects of Over-the-Counter Opioid Drugs Misuse.

Several over-the-counter (OTC) drugs are known to be misused. Among them are opioids such as codeine, dihydrocodeine, and loperamide. This work elucidates their pharmacology, interactions, safety profiles, and how pharmacology is being manipulated to misuse these common medications, with the aim to expand on the subject outlined by the authors focusing on abuse prevention and prevalence rates. The reviewed literature was identified in several online databases through searches conducted with phrases created by combining the international non-proprietary names of the drugs with terms related to drug misuse. The results show that OTC opioids are misused as an alternative for illicit narcotics, or prescription-only opioids. The potency of codeine and loperamide is strongly dependent on the individual enzymatic activity of CYP2D6 and CYP3A4, as well as P-glycoprotein function. Codeine can also be utilized as a substrate for clandestine syntheses of more potent drugs of abuse, namely desomorphine ("Krokodil"), and morphine. The dangerous methods used to prepare these substances can result in poisoning from toxic chemicals and impurities originating from the synthesis procedure. OTC opioids are generally safe when consumed in accordance with medical guidelines. However, the intake of supratherapeutic amounts of these substances may reveal surprising traits of common medications.

Assessment of Pharmacologic Ingredients in Common Over-the-Counter Sinonasal Medications.

Importance: Sinonasal remedies are the most frequently purchased category of over-the-counter (OTC) drugs in the United States. A variety of options for relief are available under proprietary names, although the actual number of available options may not be readily appreciated by the consumer or the clinician. Objective: To determine the prevalence of specific ingredients in OTC sinonasal products. Design, Setting, and Participants: This cross-sectional study took physical inventory of brand-name and generic OTC drugs marketed as sinus, cold, allergy, or nasal remedies. Retail pharmacies in New Orleans, Louisiana, commercial websites, and the Drugs, Herbs and Supplements section of MedlinePlus and drugs.com were searched. Data were collected and analyzed from July 1 to 31, 2018. Main Outcomes and Measures: Frequency of active ingredients in OTC formulations. Results: Five pharmacies were visited to identify 18 brands, for which the commercial websites were then searched. The 14 most common brands represented 211 unique products. Only 8 unique nonanalgesic ingredients were identified among these products, with many products sold under the same brand name and with the same active ingredient. Phenylephrine hydrochloride, dextromethorphan hydrobromide, pseudoephedrine hydrochloride, guaifenesin, chlorpheniramine maleate, brompheniramine maleate, diphenhydramine hydrochloride, and doxylamine succinate were the common active ingredients, with all available OTC sinonasal remedies consisting of 1 or more of these ingredients. The frequency of occurrence of each ingredient ranged from 10 to 261 different products. Combinations of 2, 3, or 4 active ingredients occurred frequently in OTC sinonasal products. Conclusions and Relevance: These findings suggest that proliferation of brand extension products under a common name is pervasive. Clinicians should be aware of the large array of redundant OTC formulations and lack of specificity when discussing brand-name sinonasal remedies with their patients.

Efficacy of Nonprescription Moisturizers for Atopic Dermatitis: An Updated Review of Clinical Evidence.

Twice-daily moisturization is recommended by international guidelines as the bedrock of the management of atopic dermatitis (AD). Moisturizers should be selected based on proven clinical effectiveness in improving the skin barrier and improving the symptoms of AD. We searched the PubMed database for clinical trials assessing daily moisturization for the treatment of AD published between 2006 and 2019. Studies had to assess the efficacy of commercially available moisturizers using objective measures of corneometry, transepidermal water loss, or incidence of flare as endpoints, and treatments had to be currently available to patients. Clinical studies showed that moisturization (typically twice daily) significantly improved the skin barrier in adults and children with AD. Longer-term flare studies showed that daily moisturization reduced the incidence of flares and extended the time between flares. Proactive moisturization of infants at high risk of developing AD may reduce its manifestation. Therapeutic moisturizers for AD are specifically formulated with ingredients that target symptoms of AD, such as itch, inflammation, or compromised skin barrier. The US FDA requires that any moisturizer available in the USA and claiming to treat AD must contain colloidal oatmeal. Healthcare providers can maximize compliance and outcomes by educating patients on the benefits of liberally applying a therapeutic moisturizer twice daily to support the skin barrier and help reduce the incidence of flares. Specific recommendations should be for clinically tested moisturizers evaluated using objective, validated skin assessments.

Certified food dyes in over the counter medicines and supplements marketed for children and pregnant women.

Food, Drug, & Cosmetic (FD&C) dyes are synthetic color additives used in food, prescription drugs and over-the-counter medicines (OTCs). Consumption of FD&C dyes has been associated with neurobehavioral behavior in some children. The amount of dye used in commercial products is proprietary, making it difficult to assess dietary intake and determine exposure in children. To date, no studies have examined FD&C dyes in OTCs or vitamins in the United States. To address this, FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2 levels were measured in prenatal vitamin tablets, children's chewable and gummy vitamins, pain reliever tablets and syrups, and cough/cold/allergy tablets and syrups. Dyes were isolated using solid phase extraction (SPE) and quantified by high performance liquid chromatography (HPLC). Dye levels varied between products with highest levels in pain reliever and cough/cold/allergy syrups. Significant variability was observed within some brands. Degradation of Red No. 40, Blue No. 1, and Yellow No. 6 was observed in the vitamin gummies. Intake of FD&C Red No. 40 is two times the US FDA ADI (accepted daily intake) for some children's pain reliever syrups and almost three times the US FDA ADI for some cough/cold/allergy syrups.

Evaluation of commercially available meth-deterrent pseudoephedrine hydrochloride products.

Pseudoephedrine (PSE) extracted from its dosage forms can be used as the starting material to prepare methamphetamine by drug abusers. Recently, some pseudoephedrine drug products marketed under the over the counter (OTC) monograph have been promoted as 'meth-deterrent'. The goal of this investigation was to evaluate the extraction and dissolution of these product against controls of non-meth-deterrent products of pseudoephedrine. Immediate release (IR) PSE OTC Product-C, Product-D and Product-E with meth-deterrent claim on their packaging were selected for this study. Accordingly, OTC IR PSE tablet Product-A and OTC extended release (ER) PSE tablet Product-B, with no meth-deterrent claims, were used as controls. The extraction studies were performed on intact tablets or capsules and on manipulated products employing water, ethanol and 0.l N HCl as solvents. The extraction studies were also performed in water at elevated temperatures by heating the water in an oven and in a microwave. The dissolution studies were performed in water and 0.1 N HCl. The amount of PSE extracted from Product-C was found similar to the amount extracted from the non-meth-deterrent control Product-A. The amount of PSE extracted from Product-D and Product-E was found lower than the amount extracted from control Product-A under the conditions studied. Product-A, Product-B, and Product-C met their respective dissolution acceptance criteria. The IR Products D and E released less than 50% drug in 12 h and did not meet either IR or ER PSE tablet USP dissolution acceptance criteria. In summary, the extraction of Product-C was found to be high (approximately 85% in 30 min) and was similar in extraction to the control Product-A. The extraction of Product-D and Product-E was found less than the extraction of control Product-A. Also, Product-D and Product-E did not exhibit complete drug release. This study showed that PSE can be extracted from Product D and Product E.

Effects of medicines used to treat gastrointestinal diseases on the pharmacokinetics of coadministered drugs: a PEARRL Review.

OBJECTIVES: Drugs used to treat gastrointestinal diseases (GI drugs) are widely used either as prescription or over-the-counter (OTC) medications and belong to both the 10 most prescribed and 10 most sold OTC medications worldwide. The objective of this review article is to discuss the most frequent interactions between GI and other drugs, including identification of the mechanisms behind these interactions, where possible. KEY FINDINGS: Current clinical practice shows that in many cases, these drugs are administered concomitantly with other drug products. Due to their metabolic properties and mechanisms of action, the drugs used to treat gastrointestinal diseases can change the pharmacokinetics of some coadministered drugs. In certain cases, these interactions can lead to failure of treatment or to the occurrence of serious adverse events. The mechanism of interaction depends highly on drug properties and differs among therapeutic categories. Understanding these interactions is essential to providing recommendations for optimal drug therapy. SUMMARY: Interactions with GI drugs are numerous and can be highly significant clinically in some cases. While alterations in bioavailability due to changes in solubility, dissolution rate, GI transit and metabolic interactions can be (for the most part) easily identified, interactions that are mediated through other mechanisms, such as permeability or microbiota, are less well-understood. Future work should focus on characterising these aspects.

Triclosan in over the counter medicines of South China.

Triclosan (TCS) is an endocrine disruptor which may affect endocrine function, antibiotic resistance, and thyroid hormone homeostasis. As a broad-spectrum antimicrobial agent used in medical and personal care products, TCS was frequently detected in human urine, indicating widespread human exposure to this chemical. Over-the-counter medicines (OTCs) may be a potential source of human exposure to TCS. In this study, 84 OTCs were collected from Guangzhou, South China, including medicines intended for both children and adults. We determined the concentration of TCS in OTCs and the estimated daily intakes (EDIs) of TCS by evaluating OTCs for different age groups of the Chinese population. Our results indicated over half of the evaluated medicines contained TCS and the highest concentration reached 7.825 ng/g, with a median value of 0.017 ng/g. TCS was frequently found in adult medicines (detected in 85% of samples), and the concentrations were significantly higher than those in children's medicines. TCS in OTCs may come from packaging materials, cultivated soils, or production process (Chinese patent medicines). The EDIs of TCS (estimated with 95th concentration in OTC medicines) were 0.305, 0.191, 0.287, 0.331, and 0.135 and 0.110 ng/kg-bw/day for infants, toddlers, children, teenagers, and adult females and males, respectively. Compared to other potential sources, human exposure to TCS from OTCs was limited in China-much less than TCS exposure through personal care products or indoor dust.

Criteria for the selection of switch OTC drugs based on patient benefits, efficacy, and safety [II]: Comparing the physicochemical and pharmaceutical properties of brand-name and switch OTC terbinafine hydrochloride cream.

The physicochemical properties (pH, yield value, and squeeze force) of a drug for dermatomycosis, a terbinafine hydrochloride-containing cream (a brand-name product), and 12 over-the-counter drugs (OTCs) were measured and compared to ascertain the characteristics of each product. The pH of the brand-name product, Lamisil, was 4.1, and that of the OTC products ranged from 4.2 to 7.6; Lamisil Plus (7.6) had a significantly higher pH. Moreover, the yield value for Lamisil, as an index of cream ductility, was 128 dyn/cm2, and that for the OTC products ranged from 110 to 887 dyn/cm2. In particular, the OTC products Damalin (887 dyn/cm2), Barriact (512 dyn/cm2), and Exiv Deep (663 dyn/cm2) had a significantly higher yield value. In addition, the squeeze force was measured by attaching a HapLog® to the thumb and second finger. The squeeze force for Lamisil was 12.9 N, and that for the OTC products ranged from 1.8 to 14.6 N. The OTC product Bilumon (1.8 N) had a significantly lower squeeze force. These results indicated that there were marked differences in the pharmaceutical properties of brand-name and OTC products. External preparations are characterized by their feel during use. Based on the current results, the pharmaceutical characteristics of drugs resulted in differences in their feel during use, suggesting that products appropriate for individual patients can be recommended.

Characterization of differential patient profiles and therapeutic responses of pharmacy customers for four ambroxol formulations.

BACKGROUND: Ambroxol relieves cough symptoms based on its secretagogue, anti-inflammatory, anti-oxidant, anti-bacterial, anti-viral, immunomodulatory and local anesthetic effects. The present study was designed to explore differential patient profiles and efficacy against acute respiratory symptoms of four formulations registered as over-the-counter medicines. METHODS: Nine hundred sixty-five pharmacy customers purchasing one of four branded ambroxol formulations (extended release capsules, adult syrup, pediatric syrup and soft pastilles) filled a questionnaire including a patient-adapted version of the Bronchitis Severity Scale, several questions on degree of impairment by acute cough, time to onset of symptom relief and duration of treatment. Data on pediatric syrup users were entered by their parents. Based on the exploratory character of the study, no hypothesis-testing statistical analysis was applied. RESULTS: Users of the pediatric syrup and the pastilles reported somewhat less severe baseline symptoms. The patient-adapted Bronchitis Severity Scale proved feasible as a self-administered tool. Among BSS items, ambroxol formulations improved chest pain while coughing to the largest and sputum to smallest degree (- 75% vs. -40%). Reported efficacy was comparable among formulations with minor differences in favor of the pediatric syrup. Time to onset of symptom relief was less than 60 min in more than 90% of patients and occurred prior to known systemic tmax. Time to onset was the parameter with the greatest differences between formulations, being reported fastest with pastilles and pediatric syrup and, as expected, slowest with extended release capsules. All ambroxol formulations were well tolerated. CONCLUSIONS: We conclude that over-the-counter formulations of ambroxol exhibit comparable user profiles and efficacy. Differences in speed of onset of symptom relief may involve not only those in systemic pharmacokinetics but also local anesthetic effects of immediate release formulations. Differences between pediatric and adult syrup may in part reflect reporting bias.

[Evaluation of Dissolution Profiles of Famotidine from OTC Drugs].

　In recent years, self-medication has started to receive more attention in Japan owing to increasing medical costs and health awareness among people. One of the main roles of pharmacists in self-medication is to provide appropriate information regarding OTC drugs. However, pharmacists promoting the proper use of OTC drugs have little information on their formulation properties. In this study, we performed dissolution tests on both OTC drugs and ethical drug (ED) containing famotidine, and evaluated the differences in their dissolution profiles. Marked differences in dissolution profiles of OTC drugs were observed in test solutions at pH 1.2, 4.0, and 6.8 and in water. To evaluate the differences quantitatively, we calculated the lag time and dissolution rate constant from the dissolution profiles. Significant differences in lag times and dissolution rate constants between some OTC drugs and ED were observed. We also used similarity factor (f2), to quantify the similarity between dissolution profiles of OTC drugs and ED. f2 values less than 42 were observed in some OTC drugs, suggesting that these differences might influence absorption in vivo resulting in differences in their onset time and efficacy. The findings of this study will provide useful information for the promotion of proper use of OTC drugs.

Assessing the bioequivalence of over-the-counter esomeprazole banded capsules and multiple-unit pellet system tablets
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OBJECTIVE: To demonstrate bioequivalence between two esomeprazole formulations under fasted and fed conditions. MATERIALS: Esomeprazole 20 mg multiunit pellet system (test; MUPS) tablets and over-the-counter esomeprazole 20 mg banded capsules (reference). MATERIALS AND METHODS: This open-label, randomized, 6-period crossover study assigned healthy males and females to receive single doses of each study drug under fasted or fed conditions. The primary pharmacokinetic endpoints were esomeprazole area under the concentration-time curve from time zero to infinity (AUCinf) and maximum observed concentration (Cmax). For endpoints with high within-subject standard deviations of the reference product (Swr ≥ 0.294), a reference scaled average bioequivalence (RSAB) approach was used. For endpoints not highly variable (Swr < 0.294), an unscaled approach was used. In the RSAB, bioequivalence was defined as the 95% criteria bound (CB) ≤ 0 and geometric mean ratios (GMRs) within 0.80, 1.25. For the unscaled approach, bioequivalence was defined as 90% confidence intervals (CIs) of the GMR being within 80%, 125%. RESULTS: 60 subjects were randomized, and 46 subjects (76.7%) completed all study periods. For esomeprazole AUCinf, the variability of the reference product was low (Swr = 0.202), so the unscaled approach was used. The GMR (90% CI) was 0.948 (0.890 - 1.010), indicating bioequivalence. For the comparison of esomeprazole Cmax, the variability of the reference product was high (Swr = 0.304), so the RSAB approach was used. The GMR (95% CB) was 1.009 (-0.050), indicating bioequivalence. CONCLUSION: Esomeprazole 20 mg MUPS tablets and banded capsules were found to be bioequivalent based on the AUCinf and Cmax in the fasted state.
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Differing disintegration and dissolution rates, pharmacokinetic profiles and gastrointestinal tolerability of over the counter ibuprofen formulations.

OBJECTIVES: Formulations of over the counter (OTC) NSAIDs differ substantially, but information is lacking on whether this alters their gastrointestinal profiles. To assess disintegration and dissolution rates and pharmacokinetics of four preparations of OTC ibuprofen and relate these with spontaneously reported gastrointestinal adverse events. METHODS: Disintegration and dissolution rates of ibuprofen tablets as (a) acid, (b) sodium salt, (c) lysine salt, and (d) as a liquid gelatine capsule were assessed. Pharmacokinetic data gastrointestinal and spontaneously reported adverse events arising from global sales were obtained from files from Reckitt Benckiser. KEY FINDINGS: Disintegration at low pH was progressively shorter for the preparations from a-to-d with formation of correspondingly smaller ibuprofen crystals, while dissolution was consistently poor. Dissolution at a neutral pH was least rapid for the liquid gelatine capsule. Pharmacokinetic data showed a shorter tmax and a higher Cmax for preparations b-d as compared with ibuprofen acid. Spontaneously reported abdominal symptoms were rare with the liquid gelatine preparation. CONCLUSIONS: The formulations of OTC ibuprofen differ in their disintegration and dissolution properties, pharmacokinetic profiles and apparent gastrointestinal tolerability. Spontaneously reported abdominal symptoms were five times lower with the liquid gelatine capsule as compared with ibuprofen acid despite a 30% increase in Cmax .

Adverse Event Trends Associated with OTC Analgesic and Antipyretic Drug: Data Mining of the Japanese Adverse Drug Event Report Database.

OTC drugs play an important role in self-medication. OTC analgesic and antipyretic drugs are widely used in Japan. The present study aimed to survey the components of OTC drug package inserts for analgesic and antipyretic drugs and to evaluate the adverse event profiles using the Japanese Adverse Drug Event Report database (JADER). The JADER contains 430587 reports from between April 2004 and November 2016; a total of 750 reports of adverse events resulted from the use of OTC analgesic and antipyretic drugs. The safety signals were detected by the reporting odds ratio (ROR). The ROR values for "Skin & subcutaneous tissue disorders", "Immune system disorders", and "Hepatobiliary disorders" stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 7.58 (6.56-8.76), 4.25 (3.51-5.14), and 2.35 (1.93-2.85), respectively. OTC analgesic and antipyretic drugs containing allylisopropylacetylurea (AIAU) exhibited a significantly high reporting ratio of "Skin & subcutaneous tissue disorders" compared with the drugs without AIAU. No difference in the reported incidence of "Hepatobiliary disorders" was found between the drugs with or without acetaminophen. Our results suggested that it was important to monitor patients who use OTC analgesic and antipyretic drug containing AIAU; in particular, careful attention should be paid to skin and subcutaneous tissue disorders.

Direct preparation of a graphene oxide modified monolith in a glass syringe as a solid-phase extraction cartridge for the extraction of quaternary ammonium alkaloids from Chinese patent medicine.

Packed cartridges have been widely used in solid-phase extraction. However, there are still some drawbacks, such as they are blocked easily and the method is time-consuming. In view of the advantages of monoliths, a monolithic extraction material has been directly synthesized in a glass syringe without any gap between the monolith and syringe inner wall. The monolithic syringe was modified with graphene oxide by loading graphene oxide dispersion onto it. The content of graphene oxide and the surface topography of the monolith have been evaluated by elemental analysis and scanning electron microscopy, respectively, which confirmed the successful modification. This prepared graphene oxide-modified monolithic syringe was directly used as a traditional solid-phase extraction cartridge. As expected, it shows good permeability and excellent capability for the extraction of quaternary ammonium alkaloids. The sample loading velocity (1-6 mL/min) does not affect the recovery. Under the optimal conditions, good linearities (R = 0.9992-0.9998) were obtained for five quaternary ammonium alkaloids, and the limits of detection and quantification were 0.5-1 and 1-2 µg/L, respectively. The proposed method was successfully applied for the analysis of quaternary ammonium alkaloids in Chinese patent medicine.

A 1% Colloidal Oatmeal Cream Alone is Effective in Reducing Symptoms of Mild to Moderate Atopic Dermatitis: Results from Two Clinical Studies.

BACKGROUND: The epidermal barrier in patients with atopic dermatitis (AD) is deficient in ceramides and cathelicidins. Such epidermal defects may be a trigger for AD, thereby encouraging research toward development of skin-barrier-targeted preventive strategies.

METHODS: Two single-center, single-arm clinical trials were conducted (study 1, age greater than equal to 8 years and study 2, greater than equal to 10 years) in patients with mild to moderate AD to evaluate the effects of an over-the-counter 1% colloidal oatmeal cream administered for 14 days. Study 1 assessed the Eczema Area and Severity Index (EASI) and Investigator's Global Atopic Dermatitis Assessment (IGADA) on day 3, and itch severity using a Visual Analogue Scale (VAS) immediately after application as primary efficacy endpoints. In study 2, the primary efficacy endpoint was change from baseline in patients' assessment of itch. Both studies assessed safety through adverse event (AE) recording.

RESULTS: Study 1: 29 patients were enrolled (mean age [range], 27.07 [8 -67]). Comparing to baseline, EASI, IGADA, and itch were improved after the application, and improvements were maintained until day 14. Improvements of greater than/equal to 20% over baseline were noted in 53.6% and 25.0% patients at day 3 for EASI and IGADA scores, respectively, and in 37.9% patients for itch score immediately after the product application. On day 14, these percentages were 82.8%, 62.1%, and 85.7%, respectively.

STUDY 2: 30 patients were enrolled (mean age [range], 32.9 [10-80]). Itch severity and EASI score were significantly improved after product application and improvements were maintained until day 14. Transepidermal water loss values were significantly reduced and skin hydration was significantly increased at all assessment time points. No adverse events (AEs) were reported in study 2 and 2 AEs were reported by 1 patient in study 1.

CONCLUSIONS: The colloidal oatmeal cream was well tolerated and clinically effective in patients with mild to moderate AD.

J Drugs Dermatol. 2017;16(7):671-676.