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Crushed Tablet Formulations

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https://www.readbyqxmd.com/read/28800385/in-vivo-and-in-vitro-palatability-testing-of-a-new-paediatric-formulation-of-valaciclovir
#1
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
AIM: 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)...
August 11, 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
#2
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
#3
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...
July 22, 2017: 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
#4
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...
June 6, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28531119/quality-attributes-and-in-vitro-bioequivalence-of-different-brands-of-amoxicillin-trihydrate-tablets
#5
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
#6
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
https://www.readbyqxmd.com/read/28405575/factorial-analysis-of-the-binding-properties-of-acetylated-ginger-starch-in-metronidazole-tablet-formulations
#7
Oluyemisi Adebowale Bamiro, Abioye Josephina Duro-Emanuel
INTRODUCTION: The delivery of drug is often affected by formulation processes and the excipients used in the formulation. MATERIALS AND METHODS: A 2(3) factorial analysis was used in this study to evaluate the effect of acetylated ginger starch (AGS) (Zingiber officinale) as a binder in metronidazole tablets, in comparison to corn starch (CS) BP. The individual and interacting effects of variables (binder type X1, binder concentration X2, and compression pressure X3) used on tablet properties such as friability, crushing strength, crushing strength friability ratio (CSFR), disintegration and crushing strength friability/disintegration time ratio (CSFR/DT) were determined...
January 2017: International Journal of Pharmaceutical Investigation
https://www.readbyqxmd.com/read/28388940/putting-the-treatment-of-paediatric-schistosomiasis-into-context
#8
REVIEW
Takafira Mduluza, Francisca Mutapi
Despite increased international efforts to control schistosomiasis using preventive chemotherapy, several challenges still exist in reaching the target populations. Until recently, preschool-aged children had been excluded from the recommended target population for mass drug administration, i.e. primary school children aged 6-15 years. Our studies and those of others provided the evidence base for the need to treat preschool-aged children that led to recommendations by the World Health Organization to include preschool-aged children in treatment programmes in 2010...
April 7, 2017: Infectious Diseases of Poverty
https://www.readbyqxmd.com/read/28352156/fixed-dose-combination-orally-disintegrating-tablets-to-treat-cardiovascular-disease-formulation-in-vitro-characterization-and-physiologically-based-pharmacokinetic-modeling-to-assess-bioavailability
#9
Thomas J Dennison, Julian C Smith, Raj K Badhan, Afzal R Mohammed
Cardiovascular disease (CVD) is the leading cause of death among men and women worldwide. In CVD, hypertension and dyslipidemia commonly coexist and are managed through coadministration of amlodipine and atorvastatin, respectively. The case for fixed-dose combination (FDC) oral dosage forms and orally disintegrating tablet (ODT) technology to enhance outcomes and compliance is strong. This work follows the development and characterization of single and FDC ODTs containing amlodipine and atorvastatin, followed by bioequivalence comparison between these single and FDC formulations, using in vitro dissolution and Caco-2 apparent permeability (Papp) and in silico physiologically based pharmacokinetic modeling approaches...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28203065/oral-drug-therapy-in-elderly-with-dysphagia-between-a-rock-and-a-hard-place
#10
REVIEW
Serena Logrippo, Giovanna Ricci, Matteo Sestili, Marco Cespi, Letizia Ferrara, Giovanni F Palmieri, Roberta Ganzetti, Giulia Bonacucina, Paolo Blasi
Demographic indicators forecast that by 2050, the elderly will account for about one-third of the global population. Geriatric patients require a large number of medicines, and in most cases, these products are administered as solid oral solid dosage forms, as they are by far the most common formulations on the market. However, this population tends to suffer difficulties with swallowing. Caregivers in hospital geriatric units routinely compound in solid oral dosage forms for dysphagic patients by crushing the tablets or opening the capsules to facilitate administration...
2017: Clinical Interventions in Aging
https://www.readbyqxmd.com/read/28171787/high-throughput-nir-chemometric-methods-for-chemical-and-pharmaceutical-characterization-of-sustained-release-tablets
#11
Alina Porfire, Cristina Filip, Ioan Tomuta
The aim of this study was the development and validation of methods based on near-infrared spectroscopy (NIRS) and chemometry, useful for characterization of sustained release (SR) tablets with indapamide, in terms of tablet composition (API and two excipients), in vitro drug release mechanism (k and n Peppas) and crushing strength. A calibration set consisting of 25 different tablets formulations containing API, HPMC and lactose at five different content levels in the range 100±20% relative to a targeted tablet composition, were manufactured by direct compression in order to develop the methods for prediction of tablet composition, and in vitro drug release mechanism...
May 10, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28127938/an-open-label-randomized-bioavailability-study-of-alternative-methods-of-oral-administration-of-naloxegol-in-healthy-subjects
#12
Khanh Bui, Bruce Birmingham, Ulysses Diva, Bruce Berger
Naloxegol is a peripherally acting μ-opioid receptor antagonist approved as an orally administered tablet for the treatment of opioid-induced constipation. Patients with swallowing difficulties may benefit from alternative approaches to the oral administration of the whole-tablet formulation of naloxegol. This open-label, randomized, 4-period, 4-treatment, crossover, single-dose study (NCT02446171) evaluated the pharmacokinetic (PK) characteristics of crushed naloxegol 25-mg tablets (suspended in water) administered orally or by nasogastric tube and a naloxegol solution compared with the commercially available 25-mg tablet formulation in healthy volunteers...
January 27, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28070847/role-of-water-sorption-in-tablet-crushing-strength-disintegration-and-dissolution
#13
M Sacchetti, R Teerakapibal, K Kim, E J Elder
Drugs formulated as tablets are subjected to accelerated stability conditions with the goal of identifying a stable formulation that will exhibit a sufficiently long shelf life. Water sorption at a condition such as 40°C/75% RH can result in significant changes in tablet properties such as a decrease in dissolution rate, the cause of which may be difficult to interpret, given the complex nature of ingredients and their interactions in a tablet. In this research, three drugs, displaying a wide range of physicochemical properties, were formulated with commonly used diluents, disintegrants, and binders, using a design of experiments approach...
January 9, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28053581/optimization-of-formulation-and-processing-of-moringa-oleifera-and-spirulina-complex-tablets
#14
Yi Zheng, Fan Zhu, Dan Lin, Jun Wu, Yichao Zhou, Bohn Mark
Objective: To prepare a more comprehensive nutrition, more balanced proportion of natural nutritional supplement tablets with Moringa oleifera leaves and spirulina the two nutrients which have complementary natural food ingredients. Method: On the basis of research M. oleifera leaves with spirulina nutrient composition was determined on M. oleifera leaves and spirulina ratio of raw materials, and the choice of microcrystalline cellulose, sodium salt of caboxy methyl cellulose(CMC),magnesium stearate excipient, through single factor and orthogonal experiment, selecting the best formula tablets prepared by powder direct compression technology, for preparation of M...
January 2017: Saudi Journal of Biological Sciences
https://www.readbyqxmd.com/read/28053507/riluzole-5-mg-ml-oral-suspension-for-optimized-drug-delivery-in-amyotrophic-lateral-sclerosis
#15
Ann Margaret Dyer, Alan Smith
The aim of the present work is to extensively evaluate the pharmaceutical attributes of currently available riluzole presentations. The article describes the limitations and risks associated with the administration of crushed tablets, including the potential for inaccurate dosing and reduced rate of absorption when riluzole is administered with high-fat foods, and the advantages that a recently approved innovative oral liquid form of riluzole confers on amyotrophic lateral sclerosis (ALS) patients. The article further evaluates the patented and innovative controlled flocculation technology used in the pseudoplastic suspension formulation to reduce the oral anesthesia seen with crushed tablets, resulting in optimized drug delivery for riluzole...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28040560/a-systematic-review-of-the-use-of-dosage-form-manipulation-to-obtain-required-doses-to-inform-use-of-manipulation-in-paediatric-practice
#16
REVIEW
Roberta H Richey, Clare Hughes, Jean V Craig, Utpal U Shah, James L Ford, Catrin E Barker, Matthew Peak, Anthony J Nunn, Mark A Turner
This study sought to determine whether there is an evidence base for drug manipulation to obtain the required dose, a common feature of paediatric clinical practice. A systematic review of the data sources, PubMed, EMBASE, CINAHL, IPA and the Cochrane database of systematic reviews, was used. Studies that considered the dose accuracy of manipulated medicines of any dosage form, evidence of safety or harm, bioavailability, patient experience, tolerability, contamination and comparison of methods of manipulation were included...
February 25, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27956191/effects-of-excipients-and-curing-process-on-the-abuse-deterrent-properties-of-directly-compressed-tablets
#17
Ziyaur Rahman, Ahmed S Zidan, Maxwell Korang-Yeboah, Yang Yang, Akhtar Siddiqui, Diaa Shakleya, Mansoor A Khan, Celia Cruz, Muhammad Ashraf
The objective of the present investigation was to understand the effects of excipients and curing process on the abuse deterrent properties (ADP) of Polyox™ based directly compressible abuse deterrent tablet formulations (ADFs). The excipients investigated were lactose (monohydrate or anhydrous), microcrystalline cellulose and hydroxypropyl methylcellulose. The ADPs studied were tablet crush resistance or hardness, particle size distribution following mechanical manipulation, drug extraction in water and alcohol, syringeability and injectability...
January 30, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27923700/continuous-monitoring-of-api-content-api-distribution-and-crushing-strength-after-tableting-via-near-infrared-chemical-imaging
#18
P R Wahl, I Pucher, O Scheibelhofer, M Kerschhaggl, S Sacher, J G Khinast
Near-infrared chemical imaging (NIR-CI) with high-speed cameras based on the push-broom acquisition principle is a rapidly-evolving and can be used for a variety of purposes, from classification (and sorting) of products to mapping spatial distribution of materials. The present study examined if NIR-CI is suitable for tablet manufacturing. To that end, the tablets were introduced into the CI system via a flat belt conveyor. A formulation, which consisted of 4wt.%-6wt.% caffeine, 5wt.% crospovidone as a disintegrant, 88wt...
February 25, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27904079/application-of-response-surface-methodology-to-estimate-the-design-space-of-pharmaceutical-diluents-for-dispensing-powdered-formulations
#19
Yasunori Miyazaki, Kozo Takayama, Tomonobu Uchino, Yoshiyuki Kagawa
Scientific approaches for dispensation are important for the quality and efficacy of drug treatments. Therefore, for the dispensation of powdered medicines, we have developed a powder blending method using a planetary centrifugal mixer (PCM) to replace the empirical manual method involving a mortar and pestle. The aim of this study was to optimize the formulation of pharmaceutical diluents for dispensing powdered medicines, using PCM. The diluents, composed of powdered lactose, crystalline lactose, and corn starch were assigned to a {3,2}-Simplex Lattice design...
2016: Chemical & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/27875913/development-and-optimization-of-a-meloxicam-%C3%AE-cyclodextrin-complex-for-orally-disintegrating-tablet-using-statistical-analysis
#20
Ahmad Ainurofiq, Syaiful Choiri
The purpose of this research was to develop an inclusion complex of meloxicam (MEL)/β-cyclodextrin (β-CD) incorporated into an orally disintegrating tablet (ODT), using statistical analysis to optimize the ODT formulation based on a quality by design (QbD) approach. MEL/β-CD complexation was performed by kneading, co-precipitation and spray drying methods under different molar ratios. Fourier transform infrared spectroscopy, X-ray diffraction and thermal analysis were utilized to evaluate the complexes. A central composite design (α = 2) was applied to optimize and assess the influence of Primojel, Primellose and crushing strength (CS) as independent variables on tablet friability, disintegration behavior, wicking properties and drug release...
December 8, 2016: Pharmaceutical Development and Technology
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