Search results for " pharmacy."
showing 10 items of 356 documents
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…
Integrating theoretical and experimental permeability estimations for provisional biopharmaceutical classification: Application to the WHO essential …
2018
The accuracy of the provisional estimation of the Biopharmaceutics Classification System (BCS) is heavily influenced by the permeability measurement. In this study, several theoretical and experimental models currently employed for BCS permeability classification have been analysed. The experimental models included the in situ rat intestinal perfusion, the ex vivo rat intestinal tissue in an Ussing chamber, the MDCK and Caco-2 cell monolayers, and the parallel artificial membrane (PAMPA). The theoretical models included the octanol-water partition coefficient and the QSPeR (Quantitative Structure-Permeability Relationship) model recently developed. For model validation, a dataset of 43 comp…
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…
Ion-exchange fibers and drugs: a transient study.
2003
The objective of this study was to theoretically model and experimentally measure the kinetics and extent of drug release from different ion-exchange materials using an in-house-designed flow-cell. Ion-exchange fibers (staple fibers and fiber cloth) were compared with commercially available ion-exchange materials (resins and gels). The functional ion-exchange groups in all the materials were weak -COOH or strong -SO3H groups. The rate and extent of drug release from the fibers (staple fiber>fiber cloth) was much higher than that from the resin or the gel. An increase in the hydrophilicity of the model drugs resulted in markedly higher rates of drug release from the fibers (nadolol>metoprolo…
Evaluation of furanocoumarins from seeds of the wild parsnip (Pastinaca sativa L. s.l.).
2018
Abstract Although the wild parsnip (Pastinaca sativa L. s.l.) fruits are known to contain linear and angular furanocoumarins, the individual components of the seeds have not been fully identified and quantitated, and, in the case of immature seeds, reported. In view of this, the main furanocoumarin compounds were extracted using pyridine, and were isolated using semi-preparative high-performance liquid chromatography. The structural elucidation of isolated compounds was done based on detailed spectral analysis conducted by liquid chromatography–electrospray ionization–mass spectrometry (LC–ESI/MS), 1H and 13C NMR and, where possible, by gas chromatography–mass spectrometry (GC–MS). The quan…
Bioadhesive Matrix Tablets Loaded with Lipophilic Nanoparticles as Vehicles for Drugs for Periodontitis Treatment: Development and Characterization
2019
Periodontitis treatment is usually focused on the reduction or eradication of periodontal pathogens using antibiotics against anaerobic bacteria, such as metronidazole (MTR). Moreover, recently the correlation between periodontal diseases and overexpression of reactive oxygen species (ROS) led to the introduction of antioxidant biomolecules in therapy. In this work, bioadhesive buccal tablets, consisting of a hydrophilic matrix loaded with metronidazole and lipophilic nanoparticles as a vehicle of curcumin, were developed. Curcumin (CUR)-loaded nanostructured lipid carriers (NLC) were prepared using glycyrrhetic acid, hexadecanol, isopropyl palmitate and Tween®
Preclinical Effect of Absorption Modifying Excipients on Rat Intestinal Transport of Model Compounds and the Mucosal Barrier Marker 51Cr-EDTA
2017
There is a renewed interest from the pharmaceutical field to develop oral formulations of compounds, such as peptides, oligonucleotides, and polar drugs. However, these often suffer from insufficient absorption across the intestinal mucosal barrier. One approach to circumvent this problem is the use of absorption modifying excipient(s) (AME). This study determined the absorption enhancing effect of four AMEs (sodium dodecyl sulfate, caprate, chitosan, N-acetylcysteine) on five model compounds in a rat jejunal perfusion model. The aim was to correlate the model compound absorption to the blood-to-lumen clearance of the mucosal marker for barrier integrity, 51Cr-EDTA. Sodium dodecyl sulfate a…
Classification or non-classification of substances with positive tumor findings in animal studies: Guidance by the German MAK commission
2019
One of the important tasks of the German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (known as the MAK Commission) is in the evaluation of a potential for carcinogenicity of hazardous substances at the workplace. Often, this evaluation is critically based on data on carcinogenic responses seen in animal studies and, if positive tumor responses have been observed, this will mostly lead to a classification of the substance under investigation into one of the classes for carcinogens. However, there are cases where it can be demonstrated with a very high degree of confidence that the tumor findings in the experimental animals are not relevant…
Efficacy of self-designed intraoral appliances in prevention of cheek, lip and tongue bite after local anesthesia administration in pediatric patients
2018
Background The occurrence of self-inflicted soft tissue injuries following administration of local anesthesia in pediatric patients who have received dental treatment has been reported. Aim: To evaluate the attitudes and knowledge regarding cheek, lip, and tongue bite post administration of local anesthesia among dental practitioners in Saudi Arabia. Additionally, the efficacies of three types of intraoral appliances on the prevention of self-harm were evaluated in pediatric patients. Material and methods A total of 301 practitioners were provided with a questionnaire consisting of 9 items. In addition, three types of intraoral appliances made of polyethylene terephthalate were designed as …
Protective effect of grape extract phospholipid vesicles against oxidative stress skin damages
2016
Abstract Grape extract rich in polyphenols (∼129 ± 32 mg of gallic acid equivalents per g of dry extract) was obtained from the pomaces of Cannonau grapes by homogenization in an ethanol/water mixture. The efficacy of ultrasounds in speeding up the extraction kinetics of polyphenols was demonstrated. The extract was incorporated in liposomes and PEVs (penetration enhancer containing vesicles) with Labrasol ® or Labrasol ® /ethanol. All the vesicles were spherical and predominantly unilamellar: liposomes were large (∼927 nm) and polydispersed (PI ∼0.56), while PEVs were small (∼140 nm) and fairly homogeneous (PI ∼0.3). Moreover, PEVs were able to incorporate a high amount of the extract (∼98…