Search results for " dosage form"
showing 10 items of 12 documents
Predicting the in vivo release from a liposomal formulation by IVIVC and non-invasive positron emission tomography imaging
2010
This study aimed to predict the in vivo performance from the in vitro release of a low-molecular weight model compound, [(18)F]-2-fluoro-2-deoxy-d-glucose ([(18)F]FDG), from liposomes and by means of positron emission tomography (PET). Liposomes composed of hydrogenated phosphatidylcholine (HPC) were prepared by a freeze-thaw method. Particle size distribution was measured by dynamic light scattering (DLS). In vitro release was examined with a dispersion method detecting the radioactivity of [(18)F]FDG. In vivo release of [(18)F]FDG, following i.p. injection of the liposomes in rats, was determined by using a Micro-PET scanner. Convolution was performed to predict the in vivo profiles from …
Multicomponent solid dispersion a new generation of solid dispersion produced by spray-drying
2020
Abstract The term “multicomponent solid dispersion” is widely used in recent literature to describe solid formulations consisting of a special excipient's mixture and active molecules finely dispersed. However, this term has not yet been defined. In this review, we aimed to improve the definition of multicomponent solid dispersions as a new generation of solid dispersions capable to improve both formulation issues and the therapeutic effect of the final dosage form. As it is well-known the use of solid dispersions to improve drug dissolution rate and solubility, this review describes the field of solid dispersions as well as the formulation strategies available for their production. In part…
Oral local drug delivery and new perspectives in oral drug formulation
2012
Modern pharmaceutical science has provided us with a wide range of substances to be administered with a wide large variety of dosage forms. Local drug delivery systems have been used for a long time; in particular, for the local therapy of diseases affecting the oral cavity. Although these diseases are often extremely responsive to local therapy, the mouth often presents various difficulties in the application of topical compounds (owing to saliva and the mouth's different functions), resulting in a short retention time of dosage forms with a consequent low therapeutic efficacy. To resolve these limitations, research today concentrates on the development of bioadhesive formulations. This re…
Are analysts doing method validation in liquid chromatography?
2014
International audience; Method validation is being applied in the reported analytical methods for decades. Even before this protocol was defined, authors already somehow validated their methods without full awareness. They wished to assure the quality of their work. Validation is an applied approach to verify that a method is suitable and rugged enough to function as a quality control tool in different locations and times. The performance parameters and statistical protocols followed throughout a validation study vary with the source of guidelines. Before single laboratory validation, an analytical method should be fully developed and optimized. The purpose of the validation is to confirm p…
Spectrophotometric estimation of bicalutamide in tablets
2007
A simple, sensitive, rapid, accurate and precise spectrophotometric method has been developed for the estimation of bicalutamide in bulk and pharmaceutical dosage forms. Bicalutamide shows maximum absorbance at 272 nm with molar absorptivity of 2.3399×10(4) l/mol/cm. Beer's law was obeyed in the concentration range of 1.5-18 μg/ml. The limit of detection and limit of quantification were found to be 0.1 and 0.4 μg/ml, respectively. Results of analysis were validated statistically and by recovery studies.
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam.
2015
Literature and experimental data relevant for the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing levetiracetam are reviewed. Data on solubility and permeability suggest that levetiracetam belongs to class I of the biopharmaceutical classification system (BCS). Levetiracetam's therapeutic use, its wide therapeutic index, and its favorable pharmacokinetic properties make levetiracetam a valid candidate for the BCS-based biowaiver approach. Further, no BE studies with levetiracetam IR formulations in which the test formulation failed to show BE with the comparator have been reported in the open lit…
Paediatric solid oral dosage forms for combination products: Improving in vitro swallowability of minitablets using binary mixtures with pellets
2023
There is a growing interest in determining and improving the acceptability of solid oral dosage forms (SODF) in paediatric populations. Combination products can be an interesting solution to combine two active pharmaceutical ingredients. This study shows that binary mixture of paediatric SODF could enhance formulation swallowability and palatability. Using the Paediatric Soft Robotic Tongue (PSRT) – an in vitro device inspired by the anatomy and physiology of 2-year-old children – we investigated the oral phase of swallowing of multi-particulate formulations, i.e., pellets (350 and 700 µm particles), minitablets (MTs, 1.8 mm), and their binary mixtures (BM), by measuring the oral swallowing…
Novel Drug Delivery System for Treatment-Resistant Schizophrenia
2021
Mucoadhesive polymers for oral transmucosal drug delivery: a review.
2012
The oral mucosa offers an interesting site for the application of dosage forms that release drugs within/throughout the oral mucosa, by assuring a high drug bioavailability for topic and systemic effects. However, the relative permeability of the oral mucosa and the washing effect related to the oral fluids and mechanical stresses must be considered in the formulation of oral dosage forms. Since a sustained drug release can be guaranteed only if dosage forms remain in contact with the oral site of absorption/application for a prolonged time, the development of mucoadhesive dosage forms is mandatory. The mucoadhesion is a complex phenomenon and the mucoadhesive bond consists of two different…