Search results for "Tablet"
showing 10 items of 133 documents
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine
2015
Literature data relevant to the biopharmaceutical properties of the active pharmaceutical ingredient (API) nifedipine are reviewed to evaluate whether a waiver of in vivo bioequivalence (BE) testing of immediate-release (IR) dosage forms formulated as tablets and soft gelatin capsules is warranted. Nifedipine's solubility and permeability, its therapeutic use and index, pharmacokinetics, food drug interactions, and any reported BE/bioavailability problems were all taken into consideration. Solubility and BA data indicate conclusively that nifedipine is a class II substance of biopharmaceutics classification system (BCS) and that the formulation of drug product plays a key role on the dissol…
Biowaiver monograph for immediate-release solid oral dosage forms: acetylsalicylic acid.
2012
A biowaiver monograph for acetylsalicylic acid (ASA) is presented. Literature and experimental data indicate that ASA is a highly soluble and highly permeable drug, leading to assignment of this active pharmaceutical ingredient (API) to Class I of the Biopharmaceutics Classification System (BCS). Limited bioequivalence (BE) studies reported in the literature indicate that products that have been tested are bioequivalent. Most of the excipients used in products with a marketing authorization in Europe are not considered to have an impact on gastrointestinal motility or permeability. Furthermore, ASA has a wide therapeutic index. Thus, the risks to the patient that might occur if a nonbioequi…
Programa experimental per al foment de l'ús de llibres de text en dispositius electrònics : estudi d'un cas
2015
L'aparició al mercat de les tauletes digitals ha marcat un abans i un després en l'ensenyament. Aquesta eina tecnològica es perfila com un recurs innovador de cara a la seua utilització educativa. I, com tots sabem, l'escola no pot quedar-se al marge d'aquesta revolució tecnològica. Analitzar l'impacte sobre l'alumnat de l'ús de les tauletes digitals, extraure els seus avantatges i inconvenients i generar idees sobre el seu ús ens pot portar a una educació de qualitat. En aquest article s’analitza la posada en pràctica d’aquest nou projecte anomenat Programa experimental per al foment de l'ús de llibres de text en dispositius electrònics anomenats tauletes digitals en un centre de titularit…
Breakthrough Pain (BTP) in Opioid-Tolerant Cancer Patients: A Pan-European Open-Label Multicentre Study with Fentanyl Buccal Tablet (FBT)
2012
ABSTRACT BTP, a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain, is a common problem in cancer patients. FBT is indicated for the treatment of BTP in adults with cancer already receiving maintenance opioid therapy for chronic cancer pain and should be titrated to an effective dose that provides adequate analgesia and minimises undesirable events. In this study, patients entered a screening period and were randomized during an open-label titration period to a starting FBT dose of 100 µg (group A) or 200 µg (group B) to identify the FBT effective dose and then treated in an open-label period (for 8 BTP episodes). Patients' inclusion followed…
Bio-predictive tablet disintegration: Effect of water diffusivity, fluid flow, food composition and test conditions
2013
Abstract Food intake may delay tablet disintegration. Current in vitro methods have little predictive potential to account for such effects. The effect of a variety of factors on the disintegration of immediate release tablets in the gastrointestinal tract has been identified. They include viscosity of the media, precipitation of food constituents on the surface of the tablet and reduction of water diffusivity in the media as well as changes in the hydrodynamics in the surrounding media of the solid dosage form. In order to improve the predictability of food affecting the disintegration of a dosage form, tablet disintegration in various types of a liquefied meal has been studied under stati…
Comparative study of the lubricant performance of Compritol® HD5 ATO and Compritol® 888 ATO: effect of polyethylene glycol behenate on lubricant capa…
2003
The aim of this paper is to study the lubricant capacity of Compritol HD5 ATO, a glyceryl and polyethylene glycol dibehenate, obtained by atomization. This material is compared to Compritol 888 ATO, constituted only by glyceryl dibehenate. First, this study verifies that Compritol HD5 ATO and Compritol 888 ATO present the same granular characteristics and that their mixes with Lactopress present no structural differences. Secondly, in term of compressibility and cohesiveness, the use of Compritol 888 ATO or Compritol HD5 ATO with Lactopress does not involve any significant modification. Finally, the minor difference of lubricant capacity between Compritol HD5 ATO and Compritol 888 ATO has n…
La lungimiranza politica di Claudio fra storiografia antica e Ragion di stato dei moderni
2018
Il contributo si concentra sul racconto tacitiano del discorso tenuto da Claudio nel 48 d.C. a favore dell’ammissione in senato dei primores della Gallia Comata, esaminando le argomentazioni usate dallo storico per chiarire le reazioni suscitate dalla loro richiesta e la linea argomentativa adottata dall’imperatore per convincere i senatori ad accettarla. Oltre ad esprimere la consapevolezza dell’efficacia dei criteri usati dai romani per istituire un ordinamento imperiale a carattere sopranazionale, il passo mostra l’abilità di Tacito nel sottolineare la pregnanza politica dell’intervento di Claudio e nel renderlo un modello meritevole di sopravvivere ed essere menzionato molti secoli più …
HTML5 tablet uutissovelluksen suunnittelu ja toteutus
2013
Keskipohjanmaa-lehdestä haluttiin toteuttaa web-pohjainen, HTML5:tä hyödyntävä tablet-uutissovellus Keski-Pohjanmaan Kirjapaino Oyj:lle. Työssä tut- kittiin uusimpia web-teknologioita, kannettavia laitteita, web-sovelluksen tekemis- tä ja tablet-sovelluksen luomista sanomalehdestä. Työn aikana toteutettiin kolme prototyyppiä ja kaksi virallista tablet-sovellusversiota. Ensimmäisessä virallisessa versiossa rakenne ja data olivat yhdessä sekä osa sovelluslogiikasta oli palvelimen koodissa. Toisessa versiossa data ja rakenne olivat erillään ja sovelluslogiikka oli tehty Javascriptillä. Tehdessä web-sovellusta tablet-laitteille selvisi, että on huomioi- tava suorituskyky ja Internet-selainten e…
Defining level A IVIVC dissolution specifications based on individual in vitro dissolution profiles of a controlled release formulation.
2018
Regulatory guidelines recommend that, when a level A IVIVC is established, dissolution specification should be established using averaged data and the maximum difference between AUC and Cmax between the reference and test formulations cannot be greater than 20%. However, averaging data assumes a loss of information and may reflect a bias in the results. The objective of the current work is to present a new approach to establish dissolution specifications using a new methodology (individual approach) instead of average data (classical approach). Different scenarios were established based on the relationship between in vitro-in vivo dissolution rate coefficient using a level A IVIVC of a cont…
Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study.
2017
Dissolution testing with biorelevant media has become widespread in the pharmaceutical industry as a means of better understanding how drugs and formulations behave in the gastrointestinal tract. Until now, however, there have been few attempts to gauge the reproducibility of results obtained with these methods. The aim of this study was to determine the interlaboratory reproducibility of biorelevant dissolution testing, using the paddle apparatus (USP 2). Thirteen industrial and three academic laboratories participated in this study. All laboratories were provided with standard protocols for running the tests: dissolution in FaSSGF to simulate release in the stomach, dissolution in a singl…