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Die Medizinische Welt Apr 1970
Topics: Dosage Forms; Humans; Injections; Pharmaceutical Vehicles; Suppositories; Tablets
PubMed: 5445123
DOI: No ID Found -
International Journal of Pharmaceutics Jan 2018It was the aim of this study to develop high drug loaded (>30%, w/w), thermoplastic polyurethane (TPU)-based dosage forms via fused deposition modelling (FDM). Model...
It was the aim of this study to develop high drug loaded (>30%, w/w), thermoplastic polyurethane (TPU)-based dosage forms via fused deposition modelling (FDM). Model drugs with different particle size and aqueous solubility were pre-processed in combination with diverse TPU grades via hot melt extrusion (HME) into filaments with a diameter of 1.75 ± 0.05 mm. Subsequently, TPU-based filaments which featured acceptable quality attributes (i.e. consistent filament diameter, smooth surface morphology and good mechanical properties) were printed into tablets. The sustained release potential of the 3D printed dosage forms was tested in vitro. Moreover, the impact of printing parameters on the in vitro drug release was investigated. TPU-based filaments could be loaded with 60% (w/w) fine drug powder without observing severe shark skinning or inconsistent filament diameter. During 3D printing experiments, HME filaments based on hard TPU grades were successfully converted into personalized dosage forms containing a high concentration of crystalline drug (up to 60%, w/w). In vitro release kinetics were mainly affected by the matrix composition and tablet infill degree. Therefore, this study clearly demonstrated that TPU-based FDM feedstock material offers a lot of formulation freedom for the development of personalized dosage forms.
Topics: Delayed-Action Preparations; Dosage Forms; Drug Liberation; Particle Size; Polyurethanes; Powders; Printing, Three-Dimensional; Solubility; Tablets; Technology, Pharmaceutical
PubMed: 29217471
DOI: 10.1016/j.ijpharm.2017.12.002 -
Pharmaceutical Research May 2017Pharmaceutical solid dosage forms (tablets or capsules) are the predominant form to administer active pharmaceutical ingredients (APIs) to the patient. Tablets are... (Review)
Review
Pharmaceutical solid dosage forms (tablets or capsules) are the predominant form to administer active pharmaceutical ingredients (APIs) to the patient. Tablets are typically powder compacts consisting of several different excipients in addition to the API. Excipients are added to a formulation in order to achieve the desired fill weight of a dosage form, to improve the processability or to affect the drug release behaviour in the body. These complex porous systems undergo different mechanisms when they come in contact with physiological fluids. The performance of a drug is primarily influenced by the disintegration and dissolution behaviour of the powder compact. The disintegration process is specifically critical for immediate-release dosage forms. Its mechanisms and the factors impacting disintegration are discussed and methods used to study the disintegration in-situ are presented. This review further summarises mathematical models used to simulate disintegration phenomena and to predict drug release kinetics.
Topics: Capsules; Chemistry, Pharmaceutical; Excipients; Humans; Powders; Solubility; Tablets; Technology, Pharmaceutical
PubMed: 28251425
DOI: 10.1007/s11095-017-2129-z -
Zhongguo Zhong Yao Za Zhi = Zhongguo... Jun 2023Oral solid dosage(OSD) occupies a key position in the market of Chinese patent medicines and new traditional Chinese medicines. Processing route is the foundation for...
Oral solid dosage(OSD) occupies a key position in the market of Chinese patent medicines and new traditional Chinese medicines. Processing route is the foundation for the research and development of traditional Chinese medicine OSDs. On the basis of prescriptions and preparation methods of 1 308 traditional Chinese medicine OSDs recorded in the Chinese Pharmacopoeia, we summarized the patterns of processing routes of both modern dosage forms(tablets, granules, and capsules) and traditional dosage forms(pills and powder) and constructed a manufacturing classification system(MCS) based on the processing routes. Based on the MCS, statistical analyses were conducted respectively on medicinal materials, pharmaceutical excipients, extraction solvents in the pretreatment process, crushed medicinal materials, methods of concentration and purification, and methods of drying and granulation, aiming to uncover the process features. The results showed that each dosage form can be prepared via different routes with different processing methods of decoction pieces and raw materials for dosage preparation. The raw materials for dosage form preparation of traditional Chinese medicine OSDs included total extract, semi-extract, and total crushed powder, which accounted for different proportions. The raw materials for traditional dosage forms are mainly decoction pieces powder. Semi-extracts are the main raw materials for tablets and capsules, which account for 64.8% and 56.3%, respectively. Total extracts are the main raw materials for granules, with a proportion of 77.8%. Compared with tablets and capsules, traditional Chinese medicine granules with dissolubility requirements had a larger proportion of water extraction process, a higher proportion of refining process(34.7%), and a lower proportion of crushed medicinal mate-rials in semi-extract granules. There are four ways to add volatile oil to the modern dosage forms of traditional Chinese medicine. In addition, some new technologies and processes have been used in concentration, filtration, and granulation processes of traditional Chinese medicine OSDs, and the application of pharmaceutical excipients is diversified. The results of this study are expected to provide reference for the processing route design and upgrading of OSDs for new traditional Chinese medicines.
Topics: Capsules; Excipients; Medicine, Chinese Traditional; Powders
PubMed: 37382000
DOI: 10.19540/j.cnki.cjcmm.20221014.301 -
Pharmazie in Unserer Zeit Sep 2011
Review
Topics: Administration, Inhalation; Administration, Oral; Adrenergic beta-Agonists; Aerosols; Child; Dosage Forms; Humans; Infusions, Parenteral; Lung; Metered Dose Inhalers; Powders
PubMed: 22299157
DOI: 10.1002/pauz.201100434 -
Chemical & Pharmaceutical Bulletin Feb 2021As a result of the research activities of the Japan Agency for Medical Research and Development (AMED), this document aims to show an approach to establishing control...
As a result of the research activities of the Japan Agency for Medical Research and Development (AMED), this document aims to show an approach to establishing control strategy for continuous manufacturing of oral solid dosage forms. The methods of drug development, technology transfer, process control, and quality control used in the current commercial batch manufacturing would be effective also in continuous manufacturing, while there are differences in the process development using continuous manufacturing and batch manufacturing. This document introduces an example of the way of thinking for establishing a control strategy for continuous manufacturing processes.
Topics: Administration, Oral; Dosage Forms; Drug Compounding; Manufacturing Industry; Quality Control
PubMed: 33298636
DOI: 10.1248/cpb.c20-00824 -
Current Drug Delivery 2014An oral pharmaceutical suspension has been one of the most favorable dosage forms for pediatric and geriatric patients or patients unable to tolerate solid dosage forms.... (Review)
Review
An oral pharmaceutical suspension has been one of the most favorable dosage forms for pediatric and geriatric patients or patients unable to tolerate solid dosage forms. The liquid form is preferred because of the ease of swallowing and flexibility in the administration of doses. This emerging area of suspensions as applied to the pharmaceutical field are discussed in the current article enlightening the vision of the readers towards pharmaceutical formulations including nanosuspensions, non-aqueous suspensions and modified release suspensions. The emphasis in the article focuses on the essential principles involved in the process of formation of different types of suspensions and their applications, since novel oral suspensions have potential to provide various strategy systems.
Topics: Administration, Oral; Chemistry, Pharmaceutical; Delayed-Action Preparations; Humans; Suspensions
PubMed: 24410269
DOI: 10.2174/1567201811666140113114926 -
Pharmaceutical Research Mar 2022To develop a new direct granule fed 3D printing method for manufacturing pharmaceutical solid dosage forms with porous structures using a thermal droplet deposition...
PURPOSE
To develop a new direct granule fed 3D printing method for manufacturing pharmaceutical solid dosage forms with porous structures using a thermal droplet deposition technology.
METHODS
Eudragit® E PO was used as the model polymer, which is well-known to be not FDM printable without additives. Wet granulation was used to produce drug loaded granules as the feedstock. The flow and feedability of the granules were evaluated. The physicochemical properties and in vitro drug release performance of the granules and the printed tablets were fully characterised.
RESULTS
Using the method developed by this study, Eudragit E PO was printed with a model drug into tablets with infills ranging from 30-100%, without additives. The drug was confirmed to be molecularly dispersed in the printed tablets. The printing quality and performances of the porous tablets were confirmed to be highly compliant with the pharmacopeia requirement. The level of infill density of the porous tablets had a significant effect on their in vitro drug release performance.
CONCLUSION
This is the first report of thermal droplet deposition printing via direct granule feeding. The results of this study demonstrated that this new printing method can be used as a potentially valuable alternative for decentralised pharmaceutical solid dosage form manufacturing.
Topics: Dosage Forms; Drug Liberation; Porosity; Printing, Three-Dimensional; Tablets; Technology, Pharmaceutical
PubMed: 35194719
DOI: 10.1007/s11095-022-03198-x -
Acta Pharmaceutica Hungarica 2005Gastroretentive dosage forms are drug delivery systems which remain in the stomach for an extended period of time, and allow both spacial and time control of drug...
Gastroretentive dosage forms are drug delivery systems which remain in the stomach for an extended period of time, and allow both spacial and time control of drug liberation. Their application can be advantageous in the case of drugs that are absorbed mainly from the upper part of the gastrointestinal tract or are unstable in the medium of distal intestinal regions. They can also be used beneficially in the local therapy of the stomach. Because of the complicated and by many factors influenced physiology of this organ, the design of such delivery systems is a task requiring due foresight and knowledge. Gastroretentive dosage forms can be floating, expandable, bioadhesive, modified shape and high density systems according to the physical property leading to prolongation of gastric residence time. Combinations of the listed categories can occur as well. Several spirited ideas and solutions have come up in the literature for the preparation of such delivery systems, but there is still need for development in the field of implementation and prediction of in vivo behaviour before these dosage forms can be elemental part of clinical practice.
Topics: Administration, Oral; Capsules; Dosage Forms; Drug Delivery Systems; Humans; Intestinal Absorption; Metabolic Clearance Rate; Pharmacokinetics
PubMed: 16318241
DOI: No ID Found -
International Journal of Pharmaceutics Aug 2021A non-destructive discrimination method for crystals in solid dosage drug forms was first developed using a combination of Raman spectroscopy and X-ray micro-computed...
Discrimination of ranitidine hydrochloride crystals using X-ray micro-computed tomography for the evaluation of three-dimensional spatial distribution in solid dosage forms.
A non-destructive discrimination method for crystals in solid dosage drug forms was first developed using a combination of Raman spectroscopy and X-ray micro-computed tomography (X-ray CT). Identification of the crystal form of an active pharmaceutical ingredient (API) at the appropriate pharmaceutical dosage is crucial, as the crystal form is a determinant of the quality and performance of the final formulation. To develop a non-destructive analytical methodology for the discrimination of solid API crystals in a solid dosage form, we utilized a combination of Raman spectroscopy and X-ray CT to differentiate between ranitidine crystal polymorphs (forms 1 and 2) in tablet formulations containing three excipients. The difference in electron density correlated with the true density between ranitidine polymorphs, thereby enabling the discrimination of crystal forms and visualization of their three-dimensional spatial localization inside the tablets through X-ray CT imaging. Furthermore, X-ray CT imaging revealed that the crystal particles were of varying densities, sizes, and shapes within the same batch. These findings suggest that X-ray CT is not only an imaging tool but also a unique method for quantitative physicochemical characterization to study crystal polymorphs and solid dosage forms.
Topics: Crystallization; Dosage Forms; Ranitidine; Spectrum Analysis, Raman; Tablets; X-Ray Microtomography
PubMed: 34192587
DOI: 10.1016/j.ijpharm.2021.120834