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ALERT: mix-ups between conventional and lipid formulations of amphotericin B can be extremely dangerous.

https://arctichealth.org/en/permalink/ahliterature135516
Source
Dynamics. 2011;22(1):24-6
Publication Type
Article
Date
2011
Author
Christine Koczmara
Heather Richardson
Sylvia Hyland
Carol S Y Lee
Nicky Hillebrand
Author Affiliation
Institute for Safe Medication Practices Canada. ckoczmara@ismp-canada.org
Source
Dynamics. 2011;22(1):24-6
Date
2011
Language
English
Publication Type
Article
Keywords
Amphotericin B - adverse effects - chemistry
Antifungal Agents - adverse effects - chemistry
Canada
Chemistry, Pharmaceutical
Humans
Lipids - chemistry
Medication Errors - statistics & numerical data
Abstract
In this column, the authors review Amphotericin B incidents reported Although amphotericin B may be less commonly used today because to ISMP Canada. In particular, we focus on incidents reported to have of alternative antifungal agents available, incident reports suggest resulted in patient harm due to mix-ups between the conventional there continues to be a need to alert practitioners to the different (non-lipid)formulation and lipid formulations of amphotericin B. formulations, and to implement system safety strategies.
PubMed ID
21469498 View in PubMed
Less detail

Amphotericin B lipid soluble formulations vs amphotericin B in cancer patients with neutropenia.

https://arctichealth.org/en/permalink/ahliterature20339
Source
Cochrane Database Syst Rev. 2000;(3):CD000969
Publication Type
Article
Date
2000
Author
H K Johansen
P C Gotzsche
Author Affiliation
The Nordic Cochrane Centre, Rigshospitalet, Dept. 7112, Blegdamsvej 9, DK-2100 Copenhagen O, Denmark. hkj@cochrane.dk
Source
Cochrane Database Syst Rev. 2000;(3):CD000969
Date
2000
Language
English
Publication Type
Article
Keywords
Amphotericin B - chemistry - therapeutic use
Antibiotics, Antifungal - chemistry - therapeutic use
Chemistry, Pharmaceutical
Humans
Neoplasms - complications
Neutropenia - complications - drug therapy
Randomized Controlled Trials
Abstract
BACKGROUND: Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever. OBJECTIVES: To compare the effect and adverse effects of AmBisome and other lipid soluble formulations of amphotericin B with conventional amphotericin B in cancer patients with neutropenia. SEARCH STRATEGY: MEDLINE and Cochrane Library. Unpublished trials from conference proceedings and contact to industry. SELECTION CRITERIA: Randomised trials comparing lipid soluble formulations of amphotericin B with conventional amphotericin B. DATA COLLECTION AND ANALYSIS: Data on mortality, invasive fungal infection, nephrotoxicity, serum creatinine and dropouts were extracted by both authors independently. MAIN RESULTS: AmBisome vs conventional amphotericin B (3 trials, 1149 patients): AmBisome tended to be more effective than conventional amphotericin B for invasive fungal infection (relative risk 0.63, 95% confidence interval 0.39 to 1.01, P=0.053) whereas there was no significant difference in mortality (relative risk 0.74, 95% CI 0.52 to 1.07). AmBisome decreased significantly the incidence of nephrotoxicity, defined as a 100% increase in serum creatinine (relative risk 0.51, 95% CI 0.40 to 0.64). Fewer patients dropped out on AmBisome but the difference was not significant (relative risk 0.78, 95% CI 0.56 to 1. 08). Amphotericin B in Intralipid vs conventional amphotericin B (4 trials, 145 patients): There were no significant differences in clinical effect whereas the patients treated with the lipid soluble formulation experienced significantly less nephrotoxicity (relative risk 0.34, 95% CI 0.15 to 0.75) and smaller increases in serum creatinine (weighted mean difference 32 micromol/l, 95% CI 21 to 43 micromol/l). Amphotericin B colloidal dispersion (ABCD) vs conventional amphotericin B (1 trial, 213 patients): There was lower nephrotoxicity with ABCD (relative risk 0.38, 95% CI 0.25 to 0.59). REVIEWER'S CONCLUSIONS: AmBisome is a better drug than conventional amphotericin B but its high cost prohibits routine use in most settings. Furthermore, the advantages of AmBisome may be smaller than indicated in our review if conventional amphotericin B is administered under optimal circumstances. It is not clear whether other lipid formulations of amphotericin B could offer a worthwhile advantage compared to conventional amphotericin B.
PubMed ID
10908480 View in PubMed
Less detail

Application of ALOGPS 2.1 to predict log D distribution coefficient for Pfizer proprietary compounds.

https://arctichealth.org/en/permalink/ahliterature9356
Source
J Med Chem. 2004 Nov 4;47(23):5601-4
Publication Type
Article
Date
Nov-4-2004
Author
Igor V Tetko
Gennadiy I Poda
Author Affiliation
Biomedical Department, Institute of Bioorganic and Petroleum Chemistry, Ukrainian Academy of Sciences, Murmanskaya 1, Kyiv, 02094, Ukraine. itetko@vcclab.org
Source
J Med Chem. 2004 Nov 4;47(23):5601-4
Date
Nov-4-2004
Language
English
Publication Type
Article
Keywords
1-Octanol
Administration, Oral
Biological Availability
Chemistry, Pharmaceutical
Databases, Factual
Drug Design
Drug Industry
Hydrogen-Ion Concentration
Neural Networks (Computer)
Pharmaceutical Preparations - chemistry - metabolism
Private Sector
Quantitative Structure-Activity Relationship
Research Support, Non-U.S. Gov't
Software
Solubility
Water
Abstract
Evaluation of the ALOGPS, ACD Labs LogD, and PALLAS PrologD suites to calculate the log D distribution coefficient resulted in high root-mean-squared error (RMSE) of 1.0-1.5 log for two in-house Pfizer's log D data sets of 17,861 and 640 compounds. Inaccuracy in log P prediction was the limiting factor for the overall log D estimation by these algorithms. The self-learning feature of the ALOGPS (LIBRARY mode) remarkably improved the accuracy in log D prediction, and an rmse of 0.64-0.65 was calculated for both data sets.
PubMed ID
15509156 View in PubMed
Less detail

Aqueous hydrocortisone mouthwash solution: clinical evaluation.

https://arctichealth.org/en/permalink/ahliterature7655
Source
Acta Odontol Scand. 1998 Jun;56(3):157-60
Publication Type
Article
Date
Jun-1998
Author
W P Holbrook
T. Kristmundsdóttir
T. Loftsson
Author Affiliation
Faculty of Odontology and Department of Pharmacy, University of Iceland, Reykjavík.
Source
Acta Odontol Scand. 1998 Jun;56(3):157-60
Date
Jun-1998
Language
English
Publication Type
Article
Keywords
Administration, Topical
Adolescent
Adult
Aged
Aged, 80 and over
Anti-Inflammatory Agents - administration & dosage - chemistry - therapeutic use
Chelating Agents - administration & dosage - chemistry - therapeutic use
Chemistry, Pharmaceutical
Child
Cyclodextrins - administration & dosage - chemistry - therapeutic use
Excipients
Female
Humans
Hydrocortisone
Lichen Planus, Oral - drug therapy
Male
Methylcellulose - analogs & derivatives
Middle Aged
Mouth Diseases - drug therapy
Mouth Mucosa - drug effects
Mouthwashes - chemistry - therapeutic use
Pharmaceutic Aids
Remission Induction
Stomatitis, Aphthous - drug therapy
Treatment Outcome
Vehicles
Viscosity
beta-Cyclodextrins
Abstract
Patients often experience difficulties in applying topical steroids in orabase to the oral mucosa, particularly when large areas need to be covered. An aqueous hydrocortisone mouthwash solution has been developed, one that was anticipated to be more acceptable to patients. The solution contains hydrocortisone (0.3% w/v) in a 4.5% (w/v) 2-hydroxypropyl-beta-cyclodextrin solution. Hydroxypropylmethylcellulose (0.5% w/v) was used to increase the viscosity of the solution and to promote the hydrocortisonecyclodextrin complex. One hundred and two patients with aphthous ulceration, lichen planus, and other mucosal conditions used the mouthwash in an open clinical efficacy study. Most patients reported some or considerable improvement following a 2-week course of treatment with the mouthwash: 26 of 33 (78.8%) patients with aphthous ulceration were 'much better', as were 26 of 54 (48.1%) patients with lichen planus and 5 of 16 (31.3%) patients with other mucosal lesions. No serious side effects were reported. Aqueous mouthwash solutions offer a potential vehicle for topical steroid therapy of oral mucosal lesions.
PubMed ID
9688224 View in PubMed
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Bioequivalence of oxycodone hydrochoride extended release tablets to marketed reference products OxyContin® in Canada and US.

https://arctichealth.org/en/permalink/ahliterature113888
Source
Int J Clin Pharmacol Ther. 2013 Nov;51(11):895-907
Publication Type
Article
Date
Nov-2013
Author
Pritti Gosai
Murray P Ducharme
Anthony R Godfrey
James C Freeman
Tausif Monif
Kshirasagar Santosh Kumar
Sudershan Kumar
Rajesh Mudnaik
Pruthvipathy Katikaneni
Source
Int J Clin Pharmacol Ther. 2013 Nov;51(11):895-907
Date
Nov-2013
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Analgesics, Opioid - pharmacokinetics
Canada
Chemistry, Pharmaceutical
Cross-Over Studies
Delayed-Action Preparations
Female
Humans
Male
Oxycodone - administration & dosage - adverse effects - pharmacokinetics
Tablets
Therapeutic Equivalency
United States
Young Adult
Abstract
Oxycodone is a semisynthetic opioid agonist used for the relief of moderate to severe pain. A new generic oxycodone hydrochloride (HCl) extended release (ER) tablet is currently being developed by Ranbaxy Pharmaceutical Inc., New Brunswick, NJ, USA.
To assess relative bioavailability of a new generic (test) formulation of oxycodone hydrochloride (HCl) extended release (ER) tablets with that of marketed reference products, OxyContin®, in Canada and USA, in healthy adult subjects under fasting and fed conditions.
Five studies were conducted in all, three of which were designed to comply with the regulatory criteria for marketing a new generic formulation of OxyContin® in Canada and the remaining two to comply with regulatory criteria for marketing a new generic formulation of OxyContin® in the USA. Each study was a balanced, randomized two-period, two-treatment, two-sequence, crossover design. A single oral dose of test or reference product was given in Period 1, followed by a 7-day washout period, after which subjects received the alternative product in Period 2. In order to block the pharmacological effects of oxycodone, subjects were administered naltrexone HCl (1 × 50 mg tablet) 12 hours prior to oxycodone HCl administration, concurrent with oxycodone HCl administration, and 12 hours after oxycodone HCl administration. Throughout the confinement portion of the study, adverse events were closely monitored. Serial blood samples were collected, following which oxycodone in plasma was estimated using a validated analytical procedure.
Oxycodone was well tolerated by subjects in both periods of each study under both fed and fasted conditions. No serious adverse events were observed. The ratios of geometric means for AUC0-t and Cmax and the affiliated 90% confidence intervals for AUC were within acceptance range recommended by Health Canada. These criteria were met for both the raw data as well as data corrected for measured drug content (potency). The ratios of geometric means and the 90% confidence intervals for AUC0-t, AUC0-8 and Cmax were within acceptance range recommended by United States Food and Drug Administration (FDA).
Results demonstrate that the test formulation of oxycodone HCl ER tablets is bioequivalent to marketed OxyContin® reference formulations in Canada and USA, when administered both under fasted and fed conditions. Additionally, oxycodone HCl ER tablets were well tolerated as a single oral dose when administered to healthy adult subjects under fasted and fed conditions.
PubMed ID
23673291 View in PubMed
Less detail

Challenge of paediatric compounding to solid dosage forms sachets and hard capsules - Finnish perspective.

https://arctichealth.org/en/permalink/ahliterature284163
Source
J Pharm Pharmacol. 2017 May;69(5):593-602
Publication Type
Article
Date
May-2017
Author
Mia Sivén
Satu Kovanen
Outi Siirola
Tuomas Hepojoki
Sari Isokirmo
Niina Laihanen
Tiina Eränen
Jukka Pellinen
Anne M Juppo
Source
J Pharm Pharmacol. 2017 May;69(5):593-602
Date
May-2017
Language
English
Publication Type
Article
Keywords
Capsules - chemistry
Cellulose - chemistry
Chemistry, Pharmaceutical - methods
Drug Compounding - methods
Excipients - chemistry
Finland
Lactose - chemistry
Pediatrics - methods
Tablets - chemistry
Abstract
The study evaluated the quality of compounded sachets and hard gelatine capsules and their feasibility in paediatric drug administration.
Commercial tablets were compounded to sachets and capsules in hospital environment, and the uniformity of content and simulated drug dose were determined.
Compounded formulations were successfully obtained for a range of drug substances; dipyridamole, spironolactone, warfarin and sotalol formulations were within acceptable limits for uniformity of content, in most cases. However, some loss of drug was seen. The type and amount of excipients were found to affect uniformity of content; good conformity of capsules was obtained using lactose monohydrate as filler, whereas microcrystalline cellulose was a better choice in sachets. In capsules, content uniformity was obtained for a range of drug doses. If the drug is aimed to be administered through a nasogastric tube, solubility of the drug and excipients should be considered, as they were found to affect the simulated drug dose in administration.
Compounded sachets and capsules fulfilled the quality requirements in most cases. In compounding, the choice of excipients should be considered as they can affect conformity of the dosage form or its usability in practice. Quality assurance of compounded formulations should be taken into consideration in hospital pharmacies.
PubMed ID
27704551 View in PubMed
Less detail

Clinical and immunologic responses to multiple doses of IMVAMUNE (Modified Vaccinia Ankara) followed by Dryvax challenge.

https://arctichealth.org/en/permalink/ahliterature87379
Source
Vaccine. 2007 Dec 12;25(51):8562-73
Publication Type
Article
Date
Dec-12-2007
Author
Frey Sharon E
Newman Frances K
Kennedy Jeffrey S
Sobek Vera
Ennis Francis A
Hill Heather
Yan Lihan K
Chaplin Paul
Vollmar Jens
Chaitman Bernard R
Belshe Robert B
Author Affiliation
Department of Medicine, Saint Louis University School of Medicine and National Institute of Allergy and Infectious Diseases Vaccine Treatment and Evaluation Unit, 1100 S. Grand Blvd (DRC-8), St. Louis, MO 63104, USA. freyse@slu.edu
Source
Vaccine. 2007 Dec 12;25(51):8562-73
Date
Dec-12-2007
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Chemistry, Pharmaceutical
Enzyme-Linked Immunosorbent Assay
Erythema - immunology
Female
Heart Diseases - genetics
Humans
Immunoglobulin G - biosynthesis - immunology
Interferon Type II - biosynthesis - genetics
Male
Plaque Assay
Skin - pathology
Smallpox Vaccine - adverse effects - immunology
T-Lymphocytes - immunology
Vaccines, Attenuated - adverse effects - immunology
Vaccinia virus - immunology
Abstract
Smallpox vaccination with replication deficient vaccinia strains such as Modified Vaccinia Ankara (MVA) may induce protective immunity with improved safety and tolerability profiles compared with currently available smallpox vaccines. Ninety subjects were randomized equally to six groups in a partially blinded, randomized, controlled clinical trial. IMVAMUNE (MVA-BN, Bavarian Nordic A/S, Kvistgård, Denmark) vaccine or placebo was administered at Study Days 0 and 28 by subcutaneous or intramuscular injection and five groups were challenged with Dryvax at study Day 112. Vaccination with two doses of IMVAMUNE was safe and well tolerated compared to Dryvax. IMVAMUNE produced comparable cellular and humoral immune responses to one dose of Dryvax and the immunity induced appears robust 90 days post-vaccination by evidence of attenuated primary cutaneous reaction responses following Dryvax. IMVAMUNE vaccination prior to Dryvax reduced virus replication at the Dryvax site, decreased the size of the primary cutaneous lesion, and decreased the time to healing but did not completely ameliorate the immune response.
PubMed ID
18036708 View in PubMed
Less detail

Collagen-gentamicin implant for prevention of sternal wound infection; long-term follow-up of effectiveness.

https://arctichealth.org/en/permalink/ahliterature150178
Source
Interact Cardiovasc Thorac Surg. 2009 Sep;9(3):454-8
Publication Type
Article
Date
Sep-2009
Author
Orjan Friberg
Lars-Göran Dahlin
Jan Källman
Erik Kihlström
Bo Söderquist
Rolf Svedjeholm
Author Affiliation
Department of Cardiothoracic Surgery and Anesthesiology, Orebro University Hospital, SE 70185 Orebro, Sweden.
Source
Interact Cardiovasc Thorac Surg. 2009 Sep;9(3):454-8
Date
Sep-2009
Language
English
Publication Type
Article
Keywords
Adult
Aged
Aged, 80 and over
Anti-Bacterial Agents - administration & dosage
Antibiotic Prophylaxis
Chemistry, Pharmaceutical
Collagen
Drug Carriers
Drug Implants
Drug Resistance, Multiple, Bacterial
Female
Gentamicins - administration & dosage
Humans
Male
Mediastinitis - microbiology - prevention & control
Middle Aged
Penicillins - administration & dosage
Staphylococcus aureus - isolation & purification
Sternum - surgery
Surgical Sponges
Surgical Wound Infection - microbiology - prevention & control
Sweden
Time Factors
Treatment Outcome
Young Adult
Abstract
In a previous randomized controlled trial (LOGIP trial) the addition of local collagen-gentamicin reduced the incidence of postoperative sternal wound infections (SWI) compared with intravenous prophylaxis only. Consequently, the technique with local gentamicin was introduced in clinical routine at the two participating centers. The aim of the present study was to re-evaluate the technique regarding the prophylactic effect against SWI and to detect potential shifts in causative microbiological agents over time. All patients in this prospective two-center study received prophylaxis with application of two collagen-gentamicin sponges between the sternal halves in addition to routine intravenous antibiotics. All patients were followed for 60 days postoperatively. From January 2007 to May 2008, 1359 patients were included. The 60-day incidences of any SWI was 3.7% and of deep SWI 1.5% (1.0% mediastinitis). Both superficial and deep SWI were significantly reduced compared with the previous control group (OR=0.34 for deep SWI, P
PubMed ID
19541691 View in PubMed
Less detail

[Complex formation of copper with levomycetin]

https://arctichealth.org/en/permalink/ahliterature13498
Source
Farm Zh. 1970 Nov-Dec;25(6):21-8
Publication Type
Article
Author
A O Medvedovs'kii
Source
Farm Zh. 1970 Nov-Dec;25(6):21-8
Language
Ukrainian
Publication Type
Article
Keywords
Chemistry, Pharmaceutical
Chloramphenicol
Copper
PubMed ID
5526470 View in PubMed
Less detail

76 records – page 1 of 8.