US Pharmacopeia Research Articles

Initial evaluation of USP apparatus 4 for measuring dissolution profile of man-made vitreous fibers

We report the successful evaluation of a US Pharmacopeia Apparatus 4 (USP-4) system in measuring the dissolution profiles of man-made vitreous fibers (MMVF)11Man-made vitreous fibers (MMVF) is the terminology commonly used in the European Union to refer to mineral wool fibers, it is also the terminology used in the classification entries for these materials in Regulation (EC) No 1272/2008 classification, labelling and packaging of substances and mixtures as the term synthetic vitreous fibers (SVF) is also used in literature and other jurisdictions to refer to mineral wool fibers.. Glass and stone wool fibers with different (high- and low-) solubility profiles were tested in closed-loop configuration using a sodium/potassium phosphate buffer solution or an acetate buffer, respectively. Results confirm a need to operate in diluted conditions to avoid silicon saturation in the simulant solution and suppression of fiber dissolution. A clear fiber-to-fiber differentiation with good cell-to-cell reproducibility was achieved. These findings support the continued development of a USP-4 protocol for MMVF in vitro acellular testing.

Variability of Commercial Saw Palmetto–Based Supplements for the Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms

ABSTRACT Purpose: Some men with mild-to-moderate benign prostatic hyperplasia/lower urinary tract symptoms use saw palmetto supplements to proactively manage their symptoms as an alternative to watchful waiting and/or to avoid prescription medication side effects. This study assessed the potency and authenticity of commercially available saw palmetto–based supplements in the United States. Materials and Methods: Twenty-eight saw palmetto berry powders, powdered extracts, berry blends, lipid extracts, and multiactive products (lycopene, pumpkin oil, etc) were purchased from major online retailers and retail stores. Total fatty acid content (% weight/weight) and individual fatty acid profile of each product were determined using validated gas chromatography-fatty acid methyl ester methodology and compared with the US Pharmacopeia monograph standards for lipidosterolic extracts of Serenoa repens. Results: Total fatty acid content ranged from 0.796% for a berry powder product to 89.923% for a lipid extract product. None of the berry powders or powdered extracts, 6 of 9 lipid extracts, and 1 multiactive product met criteria for ≥80% total fatty acid content. Only 1 of the 28 products met the US Pharmacopeia criteria for a standardized lipidosterolic extract, defined as total fatty acid content ≥80% and a fatty acid profile indicative of authentic S. repens based on the ratios of the lauric acid concentration to 9 other individual fatty acid concentrations. Conclusions: There is substantial heterogeneity in fatty acid content and profile in saw palmetto supplements. Lipidosterolic extracts of saw palmetto berries standardized to ≥80% fatty acids are most likely to meet established criteria for quality and identity.

Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance

ObjectivesTuberculosis (TB) remains a major global public health problem, especially with the recent emergence of multidrug-resistant TB and extensively drug-resistant TB. There has been little consideration of the extent of...

Quality of amoxicillin/clavulanic acid oral formulations for intended veterinary use in the UK, Malaysia, Serbia and Thailand.

Amoxicillin/clavulanate is the most commonly used oral antimicrobial drug in companion animals. The objective of the study was to detect types and frequency of deficits in the quality of veterinary oral formulations of amoxicillin/clavulanate in various countries. In a prospective study with purposive sampling, amoxicillin/clavulanate tablet formulations for canine use were collected in four countries (wholesalers or veterinary practice) and shipped to a central bioanalytical laboratory. Twenty-four samples were collected from the UK (nine), Malaysia (nine), Serbia (four) and Thailand (two), yielding 18 different formulations (10 veterinary). Packaging inspection, tablet disintegration and content assay were conducted (validated high-performance liquid chromatography with ultra-violet detection); content was acceptable when within the 90% to 120% pre-specified range (US Pharmacopeia). Secondary packaging was present for 13 of 24 samples and primary packaging integrity was verified for all but one sample. Amoxicillin trihydrate/potassium clavulanate label ratio was 4:1, except for three formulations (2:1). Tablet dose strength ranged from 250 to 625 mg. All formulations contained both analytes. For amoxicillin, two of 24 samples were out of specification with 72.8% (Malaysia) and 82.3% (Thailand) of labelled content. For clavulanate, four of 24 samples were out of specification with 46.9% (Serbia), 79.0% (UK), 84.3% (Serbia) and 86.5% (Thailand) of labelled content. One formulation (Thailand) failed for both analytes. Antimicrobial formulations of substandard quality have negative consequences for efficacy in patients and potentially promote antimicrobial resistance. There was evidence of substandard formulations in all countries, not only for amoxicillin but especially for clavulanate; this could compromise equitable access to acceptable quality essential veterinary medicines worldwide.

Development and Validation of HPLC Method For the Detection of Fusidic Acid Loaded in Non-ionic and Cationic Nanoemulsion-Based Gels

Fusidic acid (FA) is a well-known pharmaceutical antibiotic used to treat dermal infections. This experiment aimed for developing a standardized HPLC protocol to determine the accurate concentration of fusidic acid in both non-ionic and cationic nano-emulsion based gels. For this purpose, a simple, precise, accurate approach was developed. A column with reversed-phase C18 (250 mm x 4.6 mm ID x 5 m) was utilized for the separation process. The main constituents of the HPLC mobile phase were composed of water: acetonitrile (1: 4); adjusted at pH 3.3. The flow rate was 1.0 mL/minute. The optimized wavelength was selected at 235 nm. This approach achieved strong linearity for alcoholic solutions of FA when loaded at a serial concentration ranging from 12.5 to 400 µg/ml. Furthermore, the approach showed good stability and achieved full recovery and an effective separation for FA from the abovementioned formulation. Besides, the protocol validation revealed good robustness at a temperature range of 23 to 27, pH 3.0 to 3.5, detection wavelength 230 to 240 nm, flow rate 0.8 and 1.2 and mobile phase contents of (78:22 to 82:18 acetonitrile/ water). The limit of Detection was obtained 1.33 µg/ml and limit of Quantification was 4.04 µg/ml for FA that uploaded through mentioned formulations. All the validation parameters were within the acceptance criteria, as per ICH , US Pharmacopeia requirements. Overall, an affordable and reproducible method could be achieved for the detection and quantification of fusidic acid within the nano-emulsion based gels formulas.

Spectroscopy and Spectroscopic Analytical Techniques in the United States Pharmacopeia–National Formulary (USP–NF)

The U.S. Pharmacopeia (USP) is a non-profit scientific organization whose mission is to improve global public health through public standards and related programs that ensure the quality, safety and benefits of medicines and foods. Vibrational spectroscopy is an analytical tool that is used in the United States Pharmacopeia and National Formulary (USP–NF) and has been since the 1950s. We explain the organization of the documentation within the USP–NF and how vibrational spectroscopy plays an important role in this regulatory document collection.

Dissolution Testing and Content Uniformity Analysis for Metformin Tablets Using Vildagliptin as an Internal Standard

Poor-quality medicines, brand or generic, do not meet acceptable standards. Further studies must explore the status of generic medicines in Qatar and the region, especially during the GCC crisis. The research goal is to assess whether the multi-sourced antidiabetic medication, Metformin Hydrochloride (MH) tablets marketed in Qatar and other selected worldwide locations fulfill the compendial quality control parameters and in vitro bioequivalence/interchangeability requirements. Could we safely replace branded Glucophage® with generic MH without compromising the patient’s interest? This laboratory experimental study assessed the quality control parameters and in vitro bioequivalence/interchangeability requirements of sixteen marketed products of MH tablets from 11 countries in addition to 33 MH products from Qatar’s market based on the US Pharmacopeia (USP 34) guideline recommendations. Content analysis test showed that the minimum amount was 96.9% in product S10 from the International samples and 97.1% for both Neomet (Q-N.m-1) and Glucophage (Q-G.Ph-2) from Qatar’s samples, while the maximum amount was 103.3% in product S4 (Formit 500) from the international market and 101.8% in product Q-Di-4, which is Dimet -500 from Qatar’s market. The rapid increase in the percentage of the drug release is noticed in products (S2-S6-S8-S9-S10-S12-S13-s15-S16–(Q-N.m-1)-(Q-Di-1)-(Q-Di-3)-(Q-D.ph-1)-(Q-D.ph-3)-(Q-M.ph-1)-(Q-M.ph-2)-(Q-G.m-3)) as they achieved the acceptance limit at the first time point (15 min). However, the products that showed the slowest release are (S4-S11-S14-(Q-D.Ph-3)). But, eventually, at 45 min, all the products passed the dissolution test. similarity factor results revealed that the Glucophage (S15) and (Q- G.Ph-5) were found to be the most similar products to the innovator brand Glucophage® (France) with the highest similarity factors (f2= 91.1%) and (f2 = 90.0%) respectively. This research has confirmed that not all the generics are exchangeable with the reference product Glucophage®.

Physical Compatibility of Y-site Pediatric Drug Administration: A Call for Question of US Pharmacopeia Standards.

To evaluate the physical intravenous Y-site compatibility of 29 combinations of medications at commonly used pediatric concentrations using both existing and novel techniques. Medication combinations included were selected by a varied group of pediatric inpatient pharmacists, and then assessed by 3 independent reviewers for existing literature. For each combination, 2 different medications were mixed together in a 1:1 ratio and incubated at room temperature for 4 hours to simulate Y-site administration. Each sample was then analyzed using the US Pharmacopeia (USP) <788> recommended analytical technique of light obscuration (LO) in addition to novel flow imaging (FI) microscopy and backgrounded membrane imaging (BMI). Physical compatibility was determined using USP chapter <788> large volume particle count limits for all techniques. A total of 29 different medication combinations were studied. Five combinations met criteria for compatibility by all 3 techniques. The remaining 24 combinations reached the threshold to be considered incompatible by at least 1 of the 3 techniques. Light obscuration, BMI, and FI identified 14%, 59%, and 76% of combinations as incompatible, respectively. All samples deemed incompatible by LO were also incompatible by at least 1 of the other 2 techniques. Flow imaging and BMI results agreed in 69% of samples tested. Most combinations tested were found to be incompatible by at least 1 of the 3 instruments used. Light obscuration appears to have reduced accuracy for identifying particulate resulting in physical medication incompatibility when compared with the novel techniques of FI and BMI.

Monitoring Cannabinoids and the Safety of the Trace Element Profile of Light Cannabis sativa L. from Different Varieties and Geographical Origin.

Non-intoxicating Cannabis sativa L. (i.e., hemp) is increasingly used for industrial, cosmetic and food applications. Despite the fact that the EU has not yet established a regulatory framework on hazardous compounds (i.e., toxic inorganic elements), the monitoring of cannabis products is of paramount importance to safeguard consumers, also in view of the species propensity to accumulate toxic metals from the environment. The aim of this work was to assess the compliance with Law n. 242/2016 and the safety of hemp inflorescences from different varieties and Italian regions by monitoring the main cannabinoids and trace elements. All samples complied with the Italian law due to a THC content &lt;0.6% counterbalanced by high CBD levels. However, inflorescences grown in Apulia and Lombardy, and from Finola and Tiborzallasi varieties accumulated higher Cu, Co, Cr, Ni and Pb contents than products from other producing areas (i.e., Sicily and Latium) and varieties (i.e., Antal, Futura75, Kompolti and Carmagnola), being moreover above the limits set by the US Pharmacopeia. A principal component analysis confirmed that trace elements, including toxic metals, were mainly affected by the geographical origin more than the botanical variety. Overall, this study highlights the need to continuously monitor hemp products and establish the earliest related regulatory frameworks.

ASHP's second cold chain forum tackles excursion management challenges and optimization.

ASHP’s Executive Forum on Cold Chain Management met virtually October 11 to share insights on how best to receive, store, and move medications in accordance with regulatory expectations and product integrity requirements—and what to do when things go wrong. “Short-term temperature excursions do occur and will occur when you store a product and in transfer through the supply chain,” acknowledged Desmond Hunt, principal scientific liaison for the U.S. Pharmacopeia (USP) in Rockville, MD. “We’re hoping, as an industry, that we go from temperature excursion panic to temperature excursion management, knowing that these things are going to occur and planning for those worst-case events.” Hunt was the first speaker at the session “Health-Systems Design to Optimize Cold Chain Management.” The event was organized by the ASHP Innovation Center and supported by a grant from Cold Chain Technologies. The executive forum previously convened April 19, 2022, to define the current state of cold chain management and how it affects health systems. A third session is scheduled for spring 2023 and will focus on future directions of cold chain management in health systems.

GSOR9 Presentation Time: 9:40 AM: 3D-Printed Ovoids with Rotational Needle Guides for Patient-Specific Hybrid Applicator Gynecologic Brachytherapy

<h3>Purpose</h3> To develop ovoid caps having a rotational guide to assist in needle insertion to predetermined locations for preferential dose deposition. <h3>Method</h3> The custom ovoids were designed to be compatible with a titanium FSD tandem and ovoid applicator set and plastic needles (Varian, Palo Alto, CA). The rotational needle guides are designed in three parts as illustrated in Figure 1. For each ovoid, there are three needle guides on both sides of the colpostat tandems: anterior, middle, and posterior pairs. The anterior and middle needle guides are designed perpendicular to the colpostat tandem while the posterior needle guides are angled 30-degrees posteriorly. The opening for the colpostat tandem is contained within the anterior section. The posterior section of the ovoid is attached to the anterior section with a titanium screw. The middle ring is free to rotate at predetermined angles in a plane perpendicular to the tandem direction. Titanium set screws fix each component to the colpostat tandems. The custom ovoid design is fabricated with a FormLabs Form 3B 3D printer (FormLabs, Somerville, MA) using a USP (U.S. Pharmacopeia) Class VI biocompatible certified Bio-Clear resin. Printed ovoid caps are sterilized for use using a 121-degree Celsius Gravity cycle for 30 minutes. The original stainless-steel mandrins used to stiffen the needles during implantation were replaced with 16 gauges wire to provide sufficient insertion support while providing more flexibility in negotiating the needle guide angles. <h3>Result</h3> The 3D-printed ovoids were used for a patient presenting with stage IIB cervical cancer receiving 2750 cGy in five fractions of brachytherapy. Two needles were placed within the medial posterior and medial middle guides of the patient right ovoid. The middle guide was rotated 10 degrees towards the patient right (Figure 2B). The acrylic-based 3D-printed resin material has HU values closer to surrounding tissues compared to the high-density polyethylene ovoids of the standard T&O set. <h3>Discussion</h3> Hybrid gynecologic applicators are beneficial in achieving dose distributions beyond the traditional "pear-shape" but can still be limited by the applicator design. Rotational needle guides within the ovoids provides added freedom in designing a patient-specific implant to reduce dose to adjacent organs at risk.

Health advisory: melatonin use in children.

Free AccessLetters to the EditorHealth advisory: melatonin use in children Muhammad Adeel Rishi, MD, Seema Khosla, MD, Shannon S. Sullivan, MD, for the Public Safety and the Public Awareness Advisory Committees of the American Academy of Sleep Medicine Muhammad Adeel Rishi, MD Address correspondence to: Muhammad Adeel Rishi, MD, Indiana University School of Medicine, 340 W. 10th St, Indianapolis, IN 46077; Email: E-mail Address: [email protected] Indiana University School of Medicine, Indianapolis, Indiana; Search for more papers by this author , Seema Khosla, MD North Dakota Center for Sleep, Fargo, North Dakota; Search for more papers by this author , Shannon S. Sullivan, MD Division of Pulmonary, Asthma, and Sleep Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California Search for more papers by this author , for the Public Safety and the Public Awareness Advisory Committees of the American Academy of Sleep Medicine Search for more papers by this author Published Online:February 1, 2023https://doi.org/10.5664/jcsm.10332SectionsPDF ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutINTRODUCTIONAmong US adults and children, melatonin supplement consumption significantly increased from 1999 to 2020.1,2 The growing use of melatonin in children has occurred despite incomplete safety and efficacy data, reports demonstrating inconsistent dose labeling, and an increase in accidental pediatric melatonin ingestions.2,3While the perception may be that melatonin is natural and therefore safe, a recent analysis published in Morbidity and Mortality Weekly Report indicates that the annual pediatric ingestions of melatonin have risen from 8,000 in 2012 to more than 52,000 in 2021, and 15% of children with overdoses were hospitalized.2Adding to the misperception of safety, melatonin is marketed as a dietary supplement, with reduced regulatory oversight compared with pharmaceuticals.4 Variation in melatonin content is reported to be −83% to +478% of labeled content,5 with the most variability found in chewable tablets, such as those in pediatric formulations. Additionally, these supplements may be candy-like and colorful, appealing to children in particular. Melatonin is also relatively inexpensive and widely available, from grocery stores to warehouse stores where it may be sold in large quantities.With this background, the Public Safety Committee and Public Awareness Advisory Committee of the American Academy of Sleep Medicine developed a health advisory addressing the use of melatonin in children.6 The Academy advises that melatonin should be handled as any other medication and kept out of reach of children, and importantly, before starting melatonin or any supplement for their children, that parents discuss this with a pediatric health care professional to assess whether behavioral strategies may be more appropriate. Finally, if melatonin is used, a practical suggestion is to look for products with the US Pharmacopeia verified (USP verified) mark, which indicates that product was produced in a facility following Good Manufacturing Practice (GMP) standards.As the use and misuse of melatonin increases, it is important to emphasize that nonpharmacologic management techniques have been well studied and are considered safe and effective for pediatric insomnia.7 We also call for ongoing public and provider education about the appropriate role for melatonin use, and we encourage health care providers to engage with their patients about usage of melatonin.DISCLOSURE STATEMENTAll authors have seen and approved this manuscript. The authors report no conflicts of interest.REFERENCES1. Li J, Somers VK, Xu H, Lopez-Jimenez F, Covassin N. Trends in use of melatonin supplements among US adults, 1999–2018. JAMA. 2022;327(5):483–485 . CrossrefGoogle Scholar2. Lelak K, Vohra V, Neuman MI, Toce MS, Sethuraman U. Pediatric melatonin ingestions—United States, 2012–2021. MMWR Morb Mortal Wkly Rep. 2022;71(22):725–729 . CrossrefGoogle Scholar3. Lelak KA, Vohra V, Neuman MI, Farooqi A, Toce MS, Sethuraman U. COVID-19 and pediatric ingestions. Pediatrics. 2021;148(1):e2021051001 . CrossrefGoogle Scholar4. Grigg-Damberger MM, Ianakieva D. Poor quality control of over-the-counter melatonin: what they say is often not what you get. J Clin Sleep Med. 2017;13(2):163–165 . LinkGoogle Scholar5. Erland LA, Saxena PK. Melatonin natural health products and supplements: presence of serotonin and significant variability of melatonin content. J Clin Sleep Med. 2017;13(2):275–281 . LinkGoogle Scholar6. American Academy of Sleep Medicine. Health Advisory: Melatonin Use in Children and Adolescents. Adopted September 9, 2022. https://aasm.org/advocacy/position-statements/melatonin-use-in-children-and-adolescents-health-advisory/. Accessed September 20, 2022. Google Scholar7. Mindell JA, Emslie G, Blumer J, et al.. Pharmacologic management of insomnia in children and adolescents: consensus statement. Pediatrics. 2006;117(6):e1223–e1232 . CrossrefGoogle Scholar Previous article Next article FiguresReferencesRelatedDetails Volume 19 • Issue 2 • February 1, 2023ISSN (print): 1550-9389ISSN (online): 1550-9397Frequency: Monthly Metrics History Submitted for publicationSeptember 22, 2022Submitted in final revised formSeptember 30, 2022Accepted for publicationOctober 3, 2022Published onlineFebruary 1, 2023 Information© 2023 American Academy of Sleep MedicinePDF download

A review on the plant resources of important medicinal licorice

Ethnopharmacological relevanceGlycyrrizae Radix et Rhizoma has various effects, including tonifying the spleen and qi, clearing heat and toxic substances, eliminating phlegm, relieving cough and pain, and harmonizing the effects of other medicines. It is widely used in the pharmaceutical and food industries. Aims of the studyThis review systematically collates the identification of Glycyrrhiza Linn. species with medicinal value and their distributions. The morphological and genetic characteristics, distribution, quantity of reserves in China, suitable environment, and area of suitable habitat of important medicinal species were reviewed. The effects of the natural environment and cultivation management (water and nutrients) on the growth and quality of licorice were reviewed. The aim is to make people have a systematic understanding of the status of medicinal plant resources of the G. Linn., and understand the natural and human factors that affect its quality, so as to provide help for the collection of resources of the important medicinal licorice and the human control of its quality in the future. Materials and methodsWe conducted extensive searches of the primary literature, master's and doctoral theses, and pharmacopeias of many countries using PubMed, Geenmedical, CNKI, Web of Science, SCI-hub and other databases. The keywords used in searches included “classification of Glycyrrhiza,” “medicinal Glycyrrhiza,” “distribution of Glycyrrhiza,” and “suitable environment for Glycyrrhiza” The results of research conducted by our research group on the morphological and genetic characteristics, natural distribution, and effects of artificial regulation on the growth and quality of licorice were summarized. ResultsThere are approximately 29 species of G. Linn. worldwide, including 15 species with medicinal value. These species occur on all continents except Antarctica across 41 countries. Only one licorice is recorded in Indian pharmacopoia,two species are recorded in US and Japanese pharmacopoeias,and three species are recorded in most national pharmacopoeias: G. glabra Linn., G. uralensis Fisch. and G. inflata Batalin. These three medicinal licorice species are mainly distributed in Eurasia, especially Central Asia. The main morphological differences between these three medicinal licorice species are in the leaves, inflorescences, pods, and seeds, and they can be distinguished by ITS and psbA-trnH sequences. The reserves of wild licorice in China have decreased annually to 1.04 million(t) in 2010. The cultivation area of G. uralensis Fisch in China is currently approximately 26,900 hm2. Soil conditions have a substantial effect on the yield and quality of G. uralensis Fisch, especially water and nutrients. Appropriate irrigation and fertilization measures can enhance the quality of G. uralensis Fisch. ConclusionsG. Linn. species and their natural distributions were summarized. The morphology, genetic characteristics, suitable environment, and area of suitable habitat of three medicinal licorice species collected in major countries were described. The main environmental conditions and cultivation measures affecting their growth and medicinal quality were determined. This article provides a comprehensive review on G. Linn. medicinal plant resources to enhance the future use of these resources.

In Vitro and In Silico Investigations on Drug Delivery in the Mouth-Throat Models with Handihaler®.

This work aimed to evaluate the relative inhalation parameters that affect the deposition of inhaled aerosols, including mouth-throat morphology, airflow rate, and initial condition of emitted particles. In vitro experiments were conducted using the US Pharmacopeia (USP) throat and a realistic mouth-throat (RMT) with Handihaler®. Then, in silico study of the gas-solid flow was performed by computational fluid dynamics and discrete phase method. Results indicated that aerosol deposition in RMT was higher compared to that in USP throat at an airflow rate of 30 L/min, with 33.16 ± 7.84% and 21.11 ± 7.1% lung deposition in USP throat and RMT models, respectively, which showed a better correlation with in vivo data from the literature. Increasing airflow rate resulted in better drug aerosolization, while the fine particle dose trend ascended before declining, with the peak value obtained at a flow rate of 40 L/min. Overall, the effect of geometrical variation was more significant. Additionally, in silico results demonstrated clearly that the initial conditions of the emitted particles from inhalers affected the subsequent deposition. Larger momentum possessed by the central aerosol jet entering the mouth directly led to stronger impaction, which resulted in the deposition in the front region of mouth-throat models. This study is beneficial to develop an in silico method to understand the underlying mechanisms of in vivo mouth-throat deposition.

Extraction and Characterization of Pharmaceutical Grade Microcrystalline Cellulose From Bambara Nut (Voandzeia Subterranean (L) Thousars) Husk

Microcrystalline cellulose is a vital ingredient in the food, pharmaceutical, and cosmetics industries. In this study, Bambara nutshell microcrystalline cellulose (BNS-MCC) was prepared by acid hydrolysis modification of Bambara nutshell alpha-cellulose pulp. The sample was subjected to sodium hydroxide pulping (2.0% and 17.5% NaOH respectively) and a multistage pulping treatment using 3.5% nitric acid. The analysis results showed that the pulping method was effective for substantial removal of lignin with a 14.416% yield of alpha-cellulose pulp. The organoleptic and physicochemical properties of BNS-MCC were examined. The prepared BNS-MCC powder was examined using a Scanning Electron Microscope (SEM), Fourier Transform Infrared spectroscopy (FTIR), and X-ray Diffractometer (XRD). The sample’s powder flow properties (true density, Hausner index, Carr’s index, angle of repose,powder porosity, loss on drying, and moisture sorption capacity) were (1.216g/mL, 1.34, 25.75%, 39.80o, 64.7%, and 46.81%). The results of the analysis of the BNS-MCC compared well with commercial grades and conformed to US Pharmacopeia (USP) and British Pharmacopeia specifications. This result shows that Bambara nutshells have potential application for pharmaceutical grade cellulose production used in direct compression tableting.

Application of the "Method Operable Design Region" (MODR) approach for the development of a UHPLC method for the assay and purity determination of risperidone in risperidone drug substance and other formulations.

To understand the role of analytics in drug development, regulatory bodies also started using the approach of Quality by Design (QbD) during analytical method developments. The present study deals with the development of the "Method Operable Design Region" for assay and purity determination of risperidone in risperidone drug substance and formulations usingy UHPLC. Five different column chemistries, five different pH buffers, oven temperatures from 25 to 45°C, and different organic modifier composition, column lengths and flow rates were studied and statistically evaluated using Fusion QbD software. The final method parameters were selected by performing multivariable changes in a single run and evaluated using the Monte Carlo simulation approach. The uniqueness of this method is that it is mass compatible, a total of 10 peaks are separated within a short run time of 12.0min and it uses a "Platforming approach", which means the use of a single method for testing the drug substance, different strengths of a drug product and different formulations. The same method can be also used for the determination of the preservative (benzoic acid) in risperidone 1mg/ml oral solution. The use of the QbD approach is aligned with the US Pharmacopeia <1220>, BP supplementary chapter 2022 and the International Conference on Harmonization Q14 guidelines for life cycle management of analytical methods.

Physicochemical properties, acute and subchronic toxicity of nano-hydroxyapatite obtained from Lates calcarifer fish bone

As the main component of bones and teeth, hydroxyapatite (HAp) is considered a vital biomaterial in many fields. Meanwhile, fishbone by-products were used as abundant and cheap sources of natural HAp. The preparation of nano-HAp from fish bones not only contributes to increasing the value of by-products but also minimizes negative impacts on the environment. In this study, nano-HAp was successfully obtained from Lates calcarifer fish bone by the thermal calcination method. Analysis of SEM, TEM showed that the HAp nanopowders possessed an average size of 39.42 nm. The Ca/P molar ratio of 1.845 indicated that the nano-HAp powders were B-type biological hydroxyapatites, which has been confirmed by FTIR spectrum. In addition, the content of heavy metals including As, Pb, Hg, Cd and the microbial contamination are within safety limits of regulatory requirements of Vietnam regulation and US Pharmacopeia for food and dietary supplement standard. The other elements such as Fe, K, Mg, Na, Se, Zn are also present in nano-HAp. The investigation of acute toxicity shows that nano-HAp did not exhibit toxicity in Swiss mice at the highest dose of 6000 mg/kg body weight. The results of subchronic oral toxicity testing indicated that nano-HAP did not affect the behavior, body weight and hematological parameters of rabbits at doses of 50 and 100 mg/kg body weight for 28 days. The liver function indices (AST, ALT, GGT) and kidney function index (creatinine) are within normal limits. These properties suggest that nano-HAp from Lates calcarifer fish bones can be used as material in food and medicine fields.

United States Pharmacopeia guidance for compounding of allergenic extracts for allergen immunotherapy.

Patient-specific allergen-specific subcutaneous immunotherapy (SCIT) has been used as a disease modifying treatment for type 1 IgE mediated allergy to inhalants for > 100 years. Traditionally, the extracts used for a treatment set have been "mixed" under the supervision of allergists in their clinics. Until 2008, there were no specific requirements for mixing procedures. Allergenic extracts are classified as biologics by the U.S. Food and Drug Administration (FDA) and are subject to the biologics license application requirements. One of the conditions is that it must be prepared in accordance with U.S. Pharmacopeia (USP) Chapter <797>, which was first published in 2008. What allergists have always considered "mixing" of allergen extracts is considered "compounding" by the FDA and other state and federal regulatory agencies. A revision of USP Chapter <797> was proposed after a series of "never events," including deaths, from compounded products. No reports of infections from SCIT have ever been reported. "Allergy" (ACAAI, AAAAI, AAOA, and other stakeholders) worked cooperatively with the USP Compounding Expert Committee to develop Section 21. "Compounding Allergenic Extracts" of what is expected to be accepted as the next version of USP Chapter <797> in mid 2022.

Compatibility and stability of non-ionic iodinated contrast media in peritoneal dialysis solution and safe practice considerations for CT peritoneography.

Computerised tomographic (CT) peritoneography is performed on peritoneal dialysis (PD) patients to identify peritoneal boundary defects, dialysate maldistributions and loculated fluid collections. Iodinated contrast media are added to dialysate and infused through the dialysis catheter, and CT images are obtained. Chemical compatibility of contrast media with dialysis solutions has not been studied. In some institutions, pharmacists charged with oversight of compounded sterile preparations have placed a moratorium on the use of contrast media-dialysate mixtures until compatibility data become available. This study was undertaken to examine the compatibility of non-ionic iodinated contrast agents added to PD solution for the performance of CT peritoneography. 100 mL of three non-ionic iodinated contrast agents, iopamidol 370 mgI/mL, iohexol 300 mgI/mL and iodixanol 320 mgI/mL, were mixed with 2 L 1.5% dextrose PD solution and stored at 2-8°C, 25°C and 40°C. Observations at predefined intervals were made over 5 days for visual appearance, turbidity, pH, drug concentration and chemical degradation. Iopamidol, iohexol and iodixanol were stable for 5 days under study conditions. The contrast-dialysate mixture remained clear and colourless, no turbidity changes observed, pH and drug concentrations were stable and no increase in existing impurities or new impurities were detected. The addition of commonly used non-ionic iodinated contrast agents to 1.5% dextrose dialysis solution is chemically stable, meeting the criteria set forth in the standards and guidelines of the US Pharmacopeia and the Institute of Safe Medication Practices. A protocol for performing CT peritoneography is recommended herein to facilitate patient safety and diagnostic reliability of the imaging study.

ASA's Advocacy on USP &amp;lt;797&amp;gt;: The Campaign to End the 1-Hour Rule

Quality & Regulatory| May 2022 ASA's Advocacy on USP <797>: The Campaign to End the 1-Hour Rule Matthew Goldan; Matthew Goldan Search for other works by this author on: This Site PubMed Google Scholar Elizabeth Rebello, R.Ph, MD, FASA, CPPS Elizabeth Rebello, R.Ph, MD, FASA, CPPS Search for other works by this author on: This Site PubMed Google Scholar ASA Monitor May 2022, Vol. 86, 38. https://doi.org/10.1097/01.ASM.0000830864.68453.1c Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn MailTo Cite Icon Cite Get Permissions Search Site Citation Matthew Goldan, Elizabeth Rebello; ASA's Advocacy on USP <797>: The Campaign to End the 1-Hour Rule. ASA Monitor 2022; 86:38 doi: https://doi.org/10.1097/01.ASM.0000830864.68453.1c Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentAll PublicationsASA Monitor Search Advanced Search Topics: advocacy, united states pharmacopeia For over a decade, anesthesiologists and other qualified anesthesia professionals have made their voices heard against the “one-hour rule,” a restrictive standard imposed by U.S. Pharmacopeia (USP) stating that all immediate-use sterile products must be administered within one hour after the start of preparation. Over the course of this period, anesthesiologists faced confusion and disruption to their workflows, and ASA was at the forefront of this issue in support of its members, building coalitions and submitting a number of comment letters advocating for the repeal of the one-hour rule. With positive breakthroughs in the latest draft of USP's guidance, ASA is working to finally bring this issue to a clear resolution and ensure the rules around compounded sterile preparations enable qualified anesthesia professionals to provide the highest quality of care for their patients. The one-hour rule was included in the 2008 revisions of USP Chapter <797>, a standard for sterile... You do not currently have access to this content.