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Crushed Tablet Formulations

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https://www.readbyqxmd.com/read/29651781/abuse-deterrent-opioid-formulations-a-key-ingredient-in-the-recipe-to-prevent-opioid-disasters
#1
Aaron J Salwan, Nicholas E Hagemeier, Sam Harirforoosh
The US Food and Drug Administration (FDA) is encouraging the innovation of long-acting opioid formulations that are manipulation-resistant. The purpose of this commentary is to assess the benefits and limitations of abuse-deterrent opioid formulations (ADFs) and discuss their role in mitigating the current opioid epidemic. ADFs have been created with chemical properties that make it difficult for people who non-medically use prescription drugs to crush and dissolve opioid tablets, as well as by combining opioids with antagonists such as naloxone or naltrexone, which are released only when the dosage form has been manipulated or the drug is taken by a non-intended route...
April 12, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29608768/a-randomized-double-blind-double-dummy-placebo-controlled-intranasal-human-abuse-potential-study-of-oxycodone-arir-a-novel-immediate-release-abuse-deterrent-formulation
#2
Lynn R Webster, Matthew Iverson, Carmela Pantaleon, Michael D Smith, Eric R Kinzler, Stefan Aigner
Objective: Prescription opioid abuse continues to be a public health concern. Oxycodone ARIR is an immediate-release (IR) oxycodone tablet composed of multiple overlapping barriers that deter manipulation of the tablet for non-oral abuse. Design: This randomized, double-blind, double-dummy, active- and placebo-controlled, four-way crossover, intranasal human abuse potential study assessed the pharmacodynamics and pharmacokinetics of crushed intranasal oxycodone ARIR compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR...
March 28, 2018: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29513967/new-methodology-for-development-of-orodispersible-tablets-using-high-shear-granulation-process
#3
Bahaa E Ali, Ramadan I Al-Shedfat, Mohamed H Fayed, Fars K Alanazi
Development of orodispersible delivery system of high mechanical properties and low disintegration time is a big challenge. The aim of the current work was to assess and optimize the high shear granulation process as a new methodology for development of orodispersible tablets of high quality attributes using design of experiment approach. A two factor, three levels (32), full factorial design was carried out to investigate the main and interaction effects of independent variables, water amount (XI) and granulation time (X2) on the characteristics of granules and final product, tablet...
May 2017: Acta Poloniae Pharmaceutica
https://www.readbyqxmd.com/read/29499616/investigation-of-the-tableting-behavior-of-ibuprofen-dc-85-w
#4
Claudia Al-Karawi, Thorsten Cech, Florian Bang, Claudia S Leopold
The aim of the present study was to investigate the tableting behavior of Ibuprofen DC 85 W with special focus on the tablet disintegration time, the tablet crushing strength and the sticking tendency to punch surfaces. To simulate production conditions, tableting was conducted on a rotary press, equipped with three compaction stations. An I-optimal design of experiments was used to analyze the influence of the pre-compaction, the intermediate compaction and the main compaction force on the two responses: tablet disintegration time and crushing strength...
March 2, 2018: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/29476763/effect-of-crushing-cutting-into-half-or-grinding-of-co-formulated-glecaprevir-pibrentasvir-tablets-on-pharmacokinetic-measurements-in-healthy-subjects
#5
Rajneet K Oberoi, Weihan Zhao, Dilraj S Sidhu, Rolando M Viani, Roger Trinh, Wei Liu
Glecaprevir (GLE) and pibrentasvir (PIB) are direct-acting antivirals coformulated as a combination tablet for once-daily treatment of chronic hepatitis C virus infection. The objective of this study was to evaluate the effect of different methods of tablet manipulations - cutting in half, grinding into powder, or crushing- on the bioavailability of GLE and PIB relative to whole film-coated bilayer tablets. This was a Phase 1, single-dose, open-label, randomized, five-period, nonfasting, crossover study in 25 healthy adult male and female subjects...
February 21, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29337185/proliposome-tablets-manufactured-using-a-slurry-driven-lipid-enriched-powders-development-characterization-and-stability-evaluation
#6
Iftikhar Khan, Sakib Yousaf, Sneha Subramanian, Mohamed Albed Alhnan, Waqar Ahmed, Abdelbary Elhissi
Proliposome powders were prepared via a slurry method using sorbitol or D-mannitol as carbohydrate carriers in 1:10 or 1:15 w/w lipid phase to carrier ratios. Soya phosphatidylcholine (SPC) and cholesterol were employed as a lipid phase and Beclometasone dipropionate (BDP) was incorporated as a model drug. Direct compaction using a Minipress was applied on the lipid-enriched powder in order to manufacture proliposome tablets. Sorbitol-based proliposome tablets in a 1:15 w/w ratio were found to be the best formulation as it exhibited excellent powder flowability with an angle of repose of 25...
March 1, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29326482/compounded-apixaban-suspensions-for-enteral-feeding-tubes
#7
Maria L Caraballo, Seda Donmez, Kobi Nathan, Fang Zhao
Objective: There is limited information on compounded apixaban formulations for administration via enteral feeding tubes. This study was designed to identify a suitable apixaban suspension formulation that is easy to prepare in a pharmacy setting, is compatible with commonly used feeding tubes, and has a beyond-use date of 7 days. Methods: Apixaban suspensions were prepared from commercially available 5-mg Eliquis tablets. Several vehicles and compounding methods were screened for ease of preparation, dosage accuracy, and tube compatibility...
July 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/29247094/oral-medicine-modification-for-older-adults-a-qualitative-study-of-nurses
#8
Aoife Mc Gillicuddy, Abina M Crean, Maria Kelly, Laura Sahm
OBJECTIVE: Oral medicines are frequently modified (eg, tablets crushed) for older adults. However, these modifications can have clinical, legal and/or ethical implications. Nurses bear responsibility for medicine administration and hence, perform these modifications. The aim of this study was to investigate the knowledge, attitudes and beliefs of nurses about oral medicine modification for older adults. DESIGN: A qualitative study was conducted using semi-structured, face-to-face interviews with nurses providing care to older adults in acute and long-term care settings...
December 14, 2017: BMJ Open
https://www.readbyqxmd.com/read/29133560/levofloxacin-population-pharmacokinetics-in-south-african-children-treated-for-multidrug-resistant-tuberculosis
#9
Paolo Denti, Anthony J Garcia-Prats, Heather R Draper, Lubbe Wiesner, Jana Winckler, Stephanie Thee, Kelly E Dooley, Rada M Savic, Helen M McIlleron, H Simon Schaaf, Anneke C Hesseling
Background: Levofloxacin is increasingly used in the treatment of multidrug-resistant tuberculosis (MDR-TB). There are limited paediatric pharmacokinetic data to inform dose selection for children.Methods: Children routinely receiving levofloxacin (250 mg adult tablets) for MDR-TB prophylaxis or disease in Cape Town, South Africa, underwent pharmacokinetic sampling following a 15 or 20 mg/kg dose, given as whole tablet(s) or crushed, orally, or by nasogastric tube. Pharmacokinetic parameters were estimated using non-linear mixed effects modelling...
November 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29066279/formulation-of-3d-printed-tablet-for-rapid-drug-release-by-fused-deposition-modeling-screening-polymers-for-drug-release-drug-polymer-miscibility-and-printability
#10
Nayan G Solanki, Md Tahsin, Ankita V Shah, Abu T M Serajuddin
The primary aim of this study was to identify pharmaceutically acceptable amorphous polymers for producing 3D printed tablets of a model drug, haloperidol, for rapid release by fused deposition modeling. Filaments for 3D printing were prepared by hot melt extrusion at 150°C with 10% and 20% w/w of haloperidol using Kollidon® VA64, Kollicoat® IR, Affinsiol™ 15 cP, and HPMCAS either individually or as binary blends (Kollidon® VA64 + Affinisol™ 15 cP, 1:1; Kollidon® VA64 + HPMCAS, 1:1). Dissolution of crushed extrudates was studied at pH 2 and 6...
January 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29061746/efficacy-and-tolerability-outcomes-of-a-phase-ii-randomized-open-label-multicenter-study-of-a-new-water-dispersible-pediatric-formulation-of-dihydroartemisinin-piperaquine-for-the-treatment-of-uncomplicated-plasmodium-falciparum-malaria-in-african-infants
#11
Nicola Gargano, Lola Madrid, Giovanni Valentini, Umberto D'Alessandro, Tinto Halidou, Sodiomon Sirima, Antoinette Tshefu, Ali Mtoro, Samwel Gesase, Quique Bassat
Artemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce. We sought to evaluate the efficacy and safety of a new dispersible-tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed tablet (Eurartesim) in the treatment of infants with uncomplicated Plasmodium falciparum malaria. Reported here are the results of a large phase II, randomized, open-label, multicenter trial conducted in African infants (6 to 12 months of age) from Mozambique, Burkina Faso, The Gambia, the Democratic Republic of the Congo, and Tanzania...
January 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29016905/relative-abuse-of-crush-resistant-prescription-opioid-tablets-via-alternative-oral-modes-of-administration
#12
Stephen F Butler, Ryan A Black, Alison B Fleming
Objective: Some crush-resistant tablet formulations (CRTs) reduce prescription opioid abuse by nonoral routes of administration (ROAs), especially insufflation and injection, while oral abuse increases. Oral abuse involving product manipulation vs swallowing whole for CRTs and comparators was examined. Methods: Abuse by oral modes of administration (e.g., swallowing whole, chewing, dissolving in the mouth), was examined using the ASI-MV, a computerized, clinical interview for adults in substance abuse treatment from January 2009 to March 2015...
July 8, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/28989276/stability-of-medicines-after-repackaging-into-multicompartment-compliance-aids-eight-criteria-for-detection-of-visual-alteration
#13
Valerie Albert, Michael Lanz, Georgios Imanidis, Kurt E Hersberger, Isabelle Arnet
INTRODUCTION: Multicompartment compliance aids (MCA) are widely used by patients. They support the management of medication and reduce unintentional nonadherence. MCA are filled with medicines unpacked from their original packaging. Swiss pharmacists currently provide MCA for 1-2 weeks, although little and controversial information exists on the stability of repackaged medicines. OBJECTIVE: We aimed to validate the usefulness of a simple screening method capable of detecting visual stability problems with repackaged medicines...
2017: Drugs & Therapy Perspectives: for Rational Drug Selection and Use
https://www.readbyqxmd.com/read/28940174/in-vitro-drug-release-after-crushing-evaluation-of-xtampza-%C3%A2-er-and-other-er-opioid-formulations
#14
Stephen P Mayock, Said Saim, Alison B Fleming
BACKGROUND AND OBJECTIVE: Extended-release (ER) opioids are associated with high rates of abuse. Recreational opioid users often manipulate ER formulations to achieve a high plasma concentration in a short amount of time, resulting in a more rapid and intense high. Patients may also manipulate ER tablets to facilitate swallowing, without recognizing that manipulation could increase release rate. The goal of this study was to assess the ability of oxycodone DETERx (Xtampza® ER, Collegium Pharmaceutical, Inc...
December 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28800385/in-vivo-and-in-vitro-palatability-testing-of-a-new-paediatric-formulation-of-valaciclovir
#15
RANDOMIZED CONTROLLED TRIAL
Diane E T Bastiaans, Laura I Immohr, Gertrude G Zeinstra, Riet Strik-Albers, Miriam Pein-Hackelbusch, Michiel van der Flier, Anton F J de Haan, Jaap Jan Boelens, Arjan C Lankester, David M Burger, Adilia Warris
AIMS: The palatability of a new paediatric formulation of valaciclovir was assessed in children and their parents: non-inferiority of the new paediatric formulation (test formulation) compared to the reference formulation was investigated. METHODS: In vivo palatability testing was performed in a randomized, two-period, multicentre, cross-over study. Children and their parents scored the liking of the new paediatric valaciclovir formulation and the reference formulation on a 100 mm visual analogue scale (VAS)...
December 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28781909/evaluation-of-the-disintegrant-properties-of-native-starches-of-five-new-cassava-varieties-in-paracetamol-tablet-formulations
#16
Frank Kumah Adjei, Yaa Asantewaa Osei, Noble Kuntworbe, Kwabena Ofori-Kwakye
The disintegrant potential of native starches of five new cassava (Manihot esculenta Crantz.) varieties developed by the Crops Research Institute of Ghana (CRIG) was studied in paracetamol tablet formulations. The yield of the starches ranged from 8.0 to 26.7%. The starches were basic (pH: 8.1-9.9), with satisfactory moisture content (≤15%), swelling capacity (≥20%), ash values (<1%), flow properties, and negligible toxic metal ion content, and compatible with the drug. The tensile strength (Ts ), crushing strength (Cs ), and friability (Ft ) of tablets containing 5-10% w/w of the cassava starches were similar (p > 0...
2017: Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28735259/observational-study-on-the-palatability-and-tolerability-of-oral-prednisolone-and-oral-dexamethasone-in-children-in-saudi-arabia-and-the-uk
#17
Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
BACKGROUND: Short-course oral corticosteroids are routinely used to treat acute asthma and croup. We evaluated their tolerability and palatability in Saudi Arabian (SA) and UK children. METHODS: Prospective observational/interview study (3 months in each country). Palatability was evaluated using a 5-point facial Hedonicscale and tolerability by direct questioning of patient/parents. RESULTS: In SA, of 122 patients (2-10 years) recruited, 52 received prednisolone base tablets, 37 prednisolone sodium phosphate syrup and 33 received dexamethasone elixir...
January 2018: Archives of Disease in Childhood
https://www.readbyqxmd.com/read/28589306/application-of-a-biodegradable-polyesteramide-derived-from-l-alanine-as-novel-excipient-for-controlled-release-matrix-tablets
#18
Ana Dora Bonillo Martínez, Inés Carmen Rodríguez Galán, María Victoria Margarit Bellver
This pre-formulation study assays the capacity of the polyesteramide PADAS, poly (L-alanine-dodecanediol-L-alanine-sebacic), as an insoluble tablet excipient matrix for prolonged drug release. The flow properties of PADAS were suitable for tableting, and the compressibility of tablets containing exclusively PADAS was evaluated by ESEM observation of the microstructure. The tablets were resistant to crushing and non-friable and they did not undergo disintegration (typical features of an inert matrix). Tablets containing 33...
November 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28531119/quality-attributes-and-in-vitro-bioequivalence-of-different-brands-of-amoxicillin-trihydrate-tablets
#19
Moawia M Al-Tabakha, Khairi M S Fahelelbom, Dana Emad Eddin Obaid, Sadik Sayed
Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin® (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin...
May 20, 2017: Pharmaceutics
https://www.readbyqxmd.com/read/28512699/an-open-label-crossover-study-of-the-pharmacokinetics-of-the-60-mg-edoxaban-tablet-crushed-and-administered-either-by-a-nasogastric-tube-or-in-apple-puree-in-healthy-adults
#20
Kenneth Duchin, Anil Duggal, George J Atiee, Motonori Kidokoro, Tadanobu Takatani, Nicole Lazarus Shipitofsky, Ling He, George Zhang, Tarundeep Kakkar
BACKGROUND: Edoxaban is an orally active, direct factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation and for the treatment of venous thromboembolism. OBJECTIVES: This study assessed the pharmacokinetics, safety, and tolerability of the edoxaban 60-mg tablet crushed and administered via a nasogastric tube in a water suspension or orally mixed in apple puree. METHODS: This phase 1, open-label, crossover study randomized 30 healthy adults to receive three edoxaban treatment regimens (oral 60-mg edoxaban tablet, or 60-mg edoxaban tablet crushed and administered via a nasogastric tube or orally in apple puree) in one of six treatment sequences...
May 17, 2017: Clinical Pharmacokinetics
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