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2.
Acta Radiol ; 62(12): 1559-1566, 2021 Dec.
Article in English | MEDLINE | ID: mdl-33251810

ABSTRACT

BACKGROUND: Diseases of the bowel are not always displayed on conventional abdominal computed tomography (CT). The studied oral contrast agent aims to improve this. PURPOSE: To investigate whether the use of a novel oral contrast for abdominal CT enables the same diagnostic advantages as seen in magnetic resonance imaging (MRI). MATERIAL AND METHODS: Twenty-five consented volunteers drank up to 1400 mL of a stable, drinkable foam. Comments on acceptance and side effects were noted immediately and 24 h later. Foam palatability was documented through interviews, and distribution in the small bowel by Hounsfield units from the CT software. The CT results were compared with age- and sex-matched controls, pretreated according to routine. A non-enhanced abdominal CT protocol of lowest possible radiation dose was used. External referees evaluated all data obtained. RESULTS: Foam was considered odd to swallow, and fullness was reported by all volunteers after 950 mL. Five had difficulties in drinking the last 320 mL and two abstained from it. All adverse symptoms were mild. The distribution in the small bowel was on par with standard agents. Foam density revealed stability with intraluminal values of around -550 HU from stomach to terminal ileum, satisfying the requirement of a great bowel lumen-to-wall contrast. External reviewers re-evaluated all our data, and one predicted the foam to offer a potential for improved diagnostics. CONCLUSION: A CT true-negative bowel filling agent was formulated, with high acceptance, few side effects, and a potential to mimic T1-weighted MRI images.


Subject(s)
Contrast Media/administration & dosage , Food Additives/administration & dosage , Intestine, Small/diagnostic imaging , Tomography, X-Ray Computed/methods , Abdomen/diagnostic imaging , Administration, Oral , Aged , Albumins , Contrast Media/adverse effects , Contrast Media/chemistry , Eggs , Female , Flavoring Agents , Food Additives/adverse effects , Food Additives/chemistry , Healthy Volunteers , Humans , Ileum/diagnostic imaging , Male , Middle Aged , Pharmaceutic Aids/administration & dosage , Pharmaceutic Aids/adverse effects , Pharmaceutic Aids/chemistry , Phosphates , Polysaccharides, Bacterial , Potassium Compounds , Radiation Dosage , Stomach/diagnostic imaging , Water
3.
Pharm Res ; 37(12): 234, 2020 Oct 29.
Article in English | MEDLINE | ID: mdl-33123783

ABSTRACT

PURPOSE: A multitude of different versions of the same medication with different inactive ingredients are currently available. It has not been quantified how this has evolved historically. Furthermore, it is unknown whether healthcare professionals consider the inactive ingredient portion when prescribing medications to patients. METHODS: We used data mining to track the number of available formulations for the same medication over time and correlate the number of available versions in 2019 to the number of manufacturers, the years since first approval, and the number of prescriptions. A focused survey among healthcare professionals was conducted to query their consideration of the inactive ingredient portion of a medication when writing prescriptions. RESULTS: The number of available versions of a single medication have dramatically increased in the last 40 years. The number of available, different versions of medications are largely determined by the number of manufacturers producing this medication. Healthcare providers commonly do not consider the inactive ingredient portion when prescribing a medication. CONCLUSIONS: A multitude of available versions of the same medications provides a potentially under-recognized opportunity to prescribe the most suitable formulation to a patient as a step towards personalized medicine and mitigate potential adverse events from inactive ingredients.


Subject(s)
Clinical Competence/statistics & numerical data , Drug Compounding/history , Pharmaceutic Aids/adverse effects , Prescription Drugs/chemistry , Drug Prescriptions , History, 20th Century , History, 21st Century , Humans , Pharmaceutic Aids/chemistry , Pharmaceutic Aids/history , Prescription Drugs/adverse effects , Prescription Drugs/history , Surveys and Questionnaires/statistics & numerical data
4.
J Cutan Pathol ; 47(5): 470-474, 2020 May.
Article in English | MEDLINE | ID: mdl-31804714

ABSTRACT

Crospovidone is an insoluble pharmaceutical disintegrant that has been implicated in a rare foreign body reaction in injection drug users, classically associated with pulmonary angiothrombosis. We recently reported the first known cases of cutaneous crospovidone deposition. We herein report two additional cases with unique clinicopathologic manifestations, both in the setting of suspected injection drug abuse. Additionally, we provide a comprehensive overview of the distinct histomorphology and reproducible histochemistry of crospovidone.


Subject(s)
Foreign Bodies/chemically induced , Pharmaceutic Aids/adverse effects , Povidone/adverse effects , Skin/pathology , Adult , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/adverse effects , Buprenorphine/administration & dosage , Buprenorphine/adverse effects , Female , Foreign Bodies/diagnosis , Humans , Injections, Subcutaneous , Male , Substance-Related Disorders/complications , Substance-Related Disorders/diagnosis
6.
J. investig. allergol. clin. immunol ; 30(2): 86-100, 2020. tab
Article in English | IBECS | ID: ibc-195472

ABSTRACT

The European Medicines Agency defines excipients as the constituents of a pharmaceutical form apart from the active substance. Immediate hypersensitivity reactions (IHRs) caused by excipients contained in the formulation of medications have been described. However, there are no data on the prevalence of IHRs due to drug excipients. Clinical manifestations of allergy to excipients can range from skin disorders to life-threatening systemic reactions. The aim of this study was to review the literature on allergy to pharmaceutical excipients and to record the IHRs described with various types of medications, specifically reactions due to the excipients contained in their formulations. The cases reported were sorted alphabetically by type of medication and excipient in order to obtain a list of the excipients most frequently involved for each type of medication


La Agencia Europea de Medicamentos define los excipientes como los componentes de una forma farmacéutica diferenciados del principio activo. Se han descrito reacciones de hipersensibilidad inmediata causadas por los excipientes contenidos en la formulación de medicamentos. Sin embargo, no hay datos sobre la prevalencia de dichas reacciones. Las manifestaciones clínicas de la alergia a los excipientes pueden ir desde trastornos de la piel hasta reacciones sistémicas que ponen en peligro la vida. El objetivo de este estudio fue realizar una revisión de la literatura sobre la alergia a los excipientes farmacéuticos y recopilar las reacciones inmediatas descritas con diferentes tipos de medicamento, debido solo a excipientes contenidos en sus formulaciones. Los casos se clasificaron alfabéticamente por tipo de medicamento y excipiente, con el fin de obtener una lista de los excipientes más frecuentemente implicados con cada tipo de medicamento


Subject(s)
Humans , Hypersensitivity, Immediate/chemically induced , Drug Hypersensitivity , Pharmaceutic Aids/adverse effects
7.
J. investig. allergol. clin. immunol ; 30(6): 400-408, 2020. tab
Article in English | IBECS | ID: ibc-202592

ABSTRACT

The European Medicines Agency (EMA) defines excipients as the constituents of a pharmaceutical form apart from the active substance. Delayed hypersensitivity reactions (DHRs) caused by excipients contained in the formulation of medications have been described. However, there are no data on the prevalence of DHRs due to drug excipients. Clinical manifestations of allergy to excipients can range from skin disorders to life-threatening systemic reactions. The aim of this study was to perform a literature review on allergy to pharmaceutical excipients and to record the DHRs described with various types of medications, specifically due to the excipients contained in their formulations. The cases reported were sorted alphabetically by type of medication and excipient, in order to obtain a list of the excipients most frequently involved for each type of medication


La Agencia Europea de Medicamentos define los excipientes como los componentes de una forma farmacéutica diferenciados del principio activo. Se han descrito reacciones de hipersensibilidad retardada causadas por los excipientes contenidos en la formulación de medicamentos. Sin embargo, no hay datos sobre la prevalencia de dichas reacciones. Las manifestaciones clínicas de la alergia a los excipientes pueden ir desde trastornos de la piel hasta reacciones sistémicas que ponen en peligro la vida. El objetivo de este estudio fue realizar una revisión de la literatura sobre la alergia a los excipientes farmacéuticos y recopilar las reacciones de hipersensibilidad retardada descritas con diferentes tipos de medicamento, debido solo a excipientes contenidos en sus formulaciones. Los casos se clasificaron alfabéticamente por tipo de medicamento y excipiente, con el fin de obtener una lista de los excipientes más frecuentemente implicados con cada tipo de medicamento


Subject(s)
Humans , Drug Hypersensitivity/etiology , Hypersensitivity, Delayed/etiology , Pharmaceutic Aids/adverse effects , Pharmaceutical Vehicles/adverse effects
8.
Am J Dermatopathol ; 41(8): e84-e86, 2019 Aug.
Article in English | MEDLINE | ID: mdl-31335429

ABSTRACT

Crospovidone, a polymer of poly N-vinyl-2-pyrrolidone, is an inert insoluble disintegrant found in pharmaceutical tablets. This material has been encountered in the lungs of intravenous drug users and embolized with other components such as talc and microcrystalline cellulose. More recently, crospovidone has also been described in the gastrointestinal tract. We present 2 cases of cutaneous crospovidone deposition resulting from subcutaneous injection of crushed tablets, commonly known as "skin popping." Clinical presentation includes painful, inflamed papules, nodules, or ulcers with overlying eschar. Crospovidone has a distinct and reproducible histochemical staining profile. Histologic recognition of this material is important because it can guide clinicians in their diagnosis and management decisions.


Subject(s)
Analgesics, Opioid/adverse effects , Foreign Bodies/etiology , Opioid-Related Disorders/complications , Pharmaceutic Aids/adverse effects , Povidone/adverse effects , Skin/chemistry , Substance Abuse, Intravenous/complications , Adult , Analgesics, Opioid/analysis , Drug Compounding , Female , Foreign Bodies/pathology , Humans , Injections, Subcutaneous , Pharmaceutic Aids/analysis , Povidone/analysis , Skin/pathology , Tablets
18.
Eur Arch Paediatr Dent ; 13(5): 261-5, 2012 Oct.
Article in English | MEDLINE | ID: mdl-23043884

ABSTRACT

AIM: This study aimed to investigate the in vitro effects of three paediatric liquid oral medicines on bovine dental enamel subsurfaces under pH cycling conditions. METHODS: Bovine enamel blocks were evaluated for surface hardness at baseline for sample selection. 52 intact bovine enamel blocks (16mm(2)) were randomly divided into four groups (n=13) according to the immersion treatments: G1: antibiotic (Klaricid®), G2: antihistamine (Claritin®), G3: antihistamine (Dimetapp®) and G4: control (de-ionised water). The blocks were submitted to pH cycling treatments twice a day for 12 days. The medicines were evaluated for pH, viscosity, and concentration of calcium, phosphate and fluoride. After the treatment period, cross-sectional microhardness (CSMH) measurements of the enamel blocks were taken and the data, expressed in Knoop hardness number (kg/mm(2)) was used to calculate the ΔS. STATISTICS: ANOVA followed by the Tukey test were used for statistical analyses (p<0.05). RESULTS: The antibiotic Klaricid® showed the highest concentration of fluoride, calcium and phosphate. Considering pH and viscosity, the following pattern was observed according to the treatment group: G4>G1>G2>G3 and G1>G2>G3>G4 respectively. Regarding the demineralisation pattern, the following results were observed: G4>G3>G2>G1. Compared to the control, the antibiotic and both the antihistamines provoked less demineralisation of the enamel blocks (p<0.05). CONCLUSIONS: Antibiotic G1 (Klaricid®) presented an in vitro protective effect against acid attacks probably due to its mineral content and viscosity.


Subject(s)
Dental Enamel/drug effects , Pharmaceutic Aids/adverse effects , Anatomy, Cross-Sectional , Animals , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/chemistry , Brompheniramine/adverse effects , Brompheniramine/chemistry , Calcium/analysis , Cattle , Clarithromycin/adverse effects , Clarithromycin/chemistry , Dental Enamel Solubility/drug effects , Drug Combinations , Fluorides/analysis , Hardness , Histamine H1 Antagonists, Non-Sedating/adverse effects , Histamine H1 Antagonists, Non-Sedating/chemistry , Hydrogen-Ion Concentration , Loratadine/adverse effects , Loratadine/chemistry , Nasal Decongestants/adverse effects , Nasal Decongestants/chemistry , Pharmaceutic Aids/chemistry , Phosphates/analysis , Pseudoephedrine/adverse effects , Pseudoephedrine/chemistry , Random Allocation , Solutions , Tooth Demineralization/chemically induced , Viscosity
19.
Hautarzt ; 63(5): 360-3, 2012 May.
Article in German | MEDLINE | ID: mdl-22573312

ABSTRACT

We report on a patient with an iodine allergy. He developed a delayed cutaneous reaction after receiving an iodinated radiographic contrast media and at the same time topical disinfection with povidone-iodine. In the patch- and intradermal tests he showed positive results with various radiographic contrast media, povidone- iodine and iodine, but not with povidone.


Subject(s)
Drug Eruptions/diagnosis , Drug Eruptions/etiology , Povidone-Iodine/adverse effects , Aged , Contrast Media , Drug Eruptions/prevention & control , Humans , Male , Patch Tests , Pharmaceutic Aids/adverse effects , Povidone/adverse effects
20.
J Food Sci ; 77(1): T41-3, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22133102

ABSTRACT

Microwave digestion of hydrogenated cottonseed oil prior to trace nickel determination by electrothermal atomic absorption spectrometry (ETAAS) is proposed here for the first time. Currently, the methods outlined in U.S. Pharmacopeia 28 (USP28) or British Pharmacopeia (BP2003) are recommended as the official methods for analyzing nickel in hydrogenated cottonseed oil. With these methods the samples may be pre-treated by a silica or a platinum crucible. However, the samples were easily tarnished during sample pretreatment when using a silica crucible. In contrast, when using a platinum crucible, hydrogenated cottonseed oil acting as a reducing material may react with the platinum and destroy the crucible. The proposed microwave-assisted digestion avoided tarnishing of sample in the process of sample pretreatment and also reduced the cycle of analysis. The programs of microwave digestion and the parameters of ETAAS were optimized. The accuracy of the proposed method was investigated by analyzing real samples. The results were compared with the ones by pressurized-PTFE-bomb acid digestion and ones obtained by the U.S. Pharmacopeia 28 (USP28) method. The new method involves a relatively rapid matrix destruction technique compared with other present methods for the quantification of metals in oil.


Subject(s)
Cottonseed Oil/chemistry , Food Additives/chemistry , Food Contamination , Nickel/analysis , Cottonseed Oil/adverse effects , Cottonseed Oil/radiation effects , Drug Contamination , Electrochemical Techniques , Food Additives/adverse effects , Food Additives/radiation effects , Food Handling , Hot Temperature , Hydrogen Peroxide/chemistry , Hydrogenation , Hydrolysis/drug effects , Hydrolysis/radiation effects , Indicators and Reagents/chemistry , Microwaves , Nitric Acid/chemistry , Pharmaceutic Aids/adverse effects , Pharmaceutic Aids/chemistry , Polytetrafluoroethylene/chemistry , Reproducibility of Results , Spectrophotometry, Atomic , Time Factors
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