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The Journal of Pharmacy and Pharmacology Oct 2022Three-dimensional printing (3DP) has gained importance worldwide recently as a novel drug manufacturing technology. 3DP technologies are suitable in the pharmaceutical... (Review)
Review
OBJECTIVES
Three-dimensional printing (3DP) has gained importance worldwide recently as a novel drug manufacturing technology. 3DP technologies are suitable in the pharmaceutical field because of having the potential in personalized medicine. The aim of this review is to present an overview of the use of 3DP technologies in pharmaceutical area, their working principles and critical process parameters. In addition, this review presents an innovative approach that evaluates the use of 3DP technologies on disease to disease.
KEY FINDINGS
This review covers the potential use of 3DP technologies in different diseases by evaluating them on a research basis. These diseases can be summarized as cardiovascular, neurological, respiratory, oncological, inflammatory, vaginal, dermatological and other diseases. It has been focussed on manuscripts that published after 2015. Studies on the use of 3DP in each disease group have been systematically reviewed by considering the methods, types of printers used and the prepared dosage forms. Oral formulations (tablets and films), implants, topical systems and vaccines are some of the examples of the mentioned dosage forms.
SUMMARY
This review presented a systematic and novel overview of the use of 3DP in the treatment of different clinical disorders.
Topics: Dosage Forms; Precision Medicine; Printing, Three-Dimensional; Tablets; Technology, Pharmaceutical
PubMed: 36215694
DOI: 10.1093/jpp/rgab139 -
Drug Discovery Today Feb 2018Orodispersible dosage forms have a growing presence in the pharmaceutical market because their administration can improve the bioavailability of some drugs and their... (Review)
Review
Orodispersible dosage forms have a growing presence in the pharmaceutical market because their administration can improve the bioavailability of some drugs and their prescription can ameliorate patient adherence and/or compliance. Here, we review the main features of orodispersible tablets, including oral lyophilisates, and orodispersible films along with their main production technologies. We summarize the bioavailability data and critically discussed their potential to improve patient adherence and/or compliance. We revisit this information in light of both the European Union (EU) and US regulatory frameworks, focusing on the differences in the definitions of such dosage forms and the requirements for marketing authorization.
Topics: Administration, Oral; Biological Availability; Dosage Forms; Drug Delivery Systems; Humans; Marketing; Pharmaceutical Preparations; Tablets
PubMed: 29030242
DOI: 10.1016/j.drudis.2017.10.003 -
Ceska a Slovenska Farmacie : Casopis... 2022The presented review article is a compilation of several foreign reviews and experimental papers, as well as several authority guidelines, which deal with the phenomenon... (Review)
Review
The presented review article is a compilation of several foreign reviews and experimental papers, as well as several authority guidelines, which deal with the phenomenon of dose dumping of solid dosage forms with modified drug release. The aim of the publication is to present this often-neglected issue to a wider domestic audience. The work deals with two basic types of dose dumping, i.e., alcohol-induced dose dumping and food-induced dose dumping. It contains basic factors affecting this phenomenon as well as possible formulation solutions that can be used to eliminate it. Last but not least, the current requirements of the authorities are also mentioned, especially for testing newly introduced products with the presumed potential risk of dose dumping.
Topics: Delayed-Action Preparations; Chemistry, Pharmaceutical; Drug Liberation; Ethanol; Dosage Forms
PubMed: 36513519
DOI: No ID Found -
Critical Reviews in Therapeutic Drug... 1993This article begins with a review of gastric emptying, small intestine transit, and colonic transit of drug delivery systems with special attention paid to the different... (Clinical Trial)
Clinical Trial Review
This article begins with a review of gastric emptying, small intestine transit, and colonic transit of drug delivery systems with special attention paid to the different physiological processes involved in stomach emptying and to the cut-off size of nondigestible solids for passage through the gastroduodenal junction during the digestive phase. Then, the proposed means for prolonging the gastric residence time (GRT) of drug delivery systems are reviewed and analyzed with special emphasis on floating (F) dosage forms. The following means are discussed: the use of passage-delaying agents, large single-unit dosage forms, bioadhesive drug delivery systems, "heavy" pellets, and buoyant forms. In the section devoted to bioadhesive forms, the influence of the turnover time of the intestinal mucus gel layer on the performance of mucoadhesive preparations is pointed out to explain the poor results obtained in humans with such peroral products. The use of a specifically designed apparatus for measuring the total force acting vertically on an object immersed in a liquid is presented as a methodology for selecting optimized buoyant formations in vitro. Scintigraphic studies are described in nonfasting human volunteers either in upright or in supine posture, who concurrently were given one optimized F and one nonfloating (NF) hydrophilic matrix capsules of the same size, for three different sizes (small, medium, and large). In upright subjects, the F forms stayed continuously above the gastric contents irrespective of their size, whereas the NF ones sank rapidly after administration and never rose back to the surface thereafter. Consequently, the F forms show prolonged and more reproducible GRTs compared to the NF ones. The significance and extent of this prolongation are the most marked for the small size units (p < 0.001) but gradually lessen as the dosage form size increases (p < 0.05 for the medium size units), to become insignificant for the large size units (p > 0.05). Moreover, there is no significant difference between the mean GRTs of the small, medium, and large F units (p > 0.05). This indirectly confirms that the intragastric buoyancy of the F forms is the main process determining their prolonged GRT and protecting them from random gastric emptying related to antral peristaltism. Thus, their GRT depends mainly on the occurrence of the end point of digestion. To the contrary, the lasting retention of the NF forms in the stomach is only size dependent.(ABSTRACT TRUNCATED AT 400 WORDS)
Topics: Administration, Oral; Animals; Capsules; Delayed-Action Preparations; Dosage Forms; Drug Carriers; Drug Delivery Systems; Gastric Mucosa; Gastrointestinal Transit; Humans; Microspheres; Particle Size; Polymers; Tablets
PubMed: 8370085
DOI: No ID Found -
The Journal of Pharmacy and Pharmacology Oct 2022Additive manufacturing (AM), commonly known as 3D printing (3DP), has opened new frontiers in pharmaceutical applications. This review is aimed to summarise the recent... (Review)
Review
OBJECTIVE
Additive manufacturing (AM), commonly known as 3D printing (3DP), has opened new frontiers in pharmaceutical applications. This review is aimed to summarise the recent development of 3D-printed dosage forms, from a pharmacists' perspective.
METHODS
Keywords including additive manufacturing, 3D printing and drug delivery were used for literature search in PubMed, Excerpta Medica Database (EMBASE) and Web of Science, to identify articles published in the year 2020.
RESULTS
For each 3DP study, the active pharmaceutical ingredients, 3D printers and materials used for the printing were tabulated and discussed. 3DP has found its applications in various dosage forms for oral delivery, transdermal delivery, rectal delivery, vaginal delivery, implant and bone scaffolding. Several topics were discussed in detail, namely patient-specific dosing, customisable drug administration, multidrug approach, varying drug release, compounding pharmacy, regulatory progress and future perspectives. AM is expected to become a common tool in compounding pharmacies to make polypills and personalised medications.
CONCLUSION
3DP is an enabling tool to fabricate dosage forms with intricate structure designs, tailored dosing, drug combinations and controlled release, all of which lend it to be highly conducive to personalisation, thereby revolutionising the future of pharmacy practice.
Topics: Delayed-Action Preparations; Dosage Forms; Drug Delivery Systems; Drug Liberation; Humans; Pharmacists; Printing, Three-Dimensional; Technology, Pharmaceutical
PubMed: 35191505
DOI: 10.1093/jpp/rgab168 -
AAPS PharmSciTech Jan 2018The choice of excipients constitutes a major part of preformulation and formulation studies during the preparation of pharmaceutical dosage forms. The physical,... (Review)
Review
The choice of excipients constitutes a major part of preformulation and formulation studies during the preparation of pharmaceutical dosage forms. The physical, mechanical, and chemical properties of excipients affect various formulation parameters, such as disintegration, dissolution, and shelf life, and significantly influence the final product. Therefore, several studies have been performed to evaluate the effect of drug-excipient interactions on the overall formulation. This article reviews the information available on the physical and chemical instabilities of excipients and their incompatibilities with the active pharmaceutical ingredient in solid oral dosage forms, during various drug-manufacturing processes. The impact of these interactions on the drug formulation process has been discussed in detail. Examples of various excipients used in solid oral dosage forms have been included to elaborate on different drug-excipient interactions.
Topics: Administration, Oral; Capsules; Drug Compounding; Drug Stability; Excipients; Tablets
PubMed: 28895106
DOI: 10.1208/s12249-017-0864-4 -
International Journal of Pharmaceutics Sep 2022Three-dimensional (3D) printing has been gaining attention as a new technological approach to obtain immediate release (IR) dosage forms. The versatility conferred by 3D... (Review)
Review
Three-dimensional (3D) printing has been gaining attention as a new technological approach to obtain immediate release (IR) dosage forms. The versatility conferred by 3D printing techniques arises from the suitability of using different polymeric materials in the production of solids with different porosities, geometries, sizes, and infill patterns. The appropriate choice of polymer can facilitate in reaching IR specifications and afford other specific properties to 3D printed solid dosage forms. This review aims to provide an overview of the polymers that have been employed in the development of IR 3D printed dosage forms, mainly considering their in vitro drug release behaviour. The physicochemical and mechanical properties of the IR 3D printed dosage forms will also be discussed, together with the manufacturing process strategies. Up to now, methacrylic polymers, cellulosic polymers, vinyl derivatives, glycols and different polymeric blends have been explored to produce IR 3D printed dosage forms. Their effects on drug release profiles are critically discussed here, giving a complete overview to drive formulators towards a rational choice of polymeric material and thus contributing to future studies in 3D printing of pharmaceuticals.
Topics: Dosage Forms; Drug Liberation; Polymers; Printing, Three-Dimensional; Tablets; Technology, Pharmaceutical
PubMed: 35926751
DOI: 10.1016/j.ijpharm.2022.122066 -
Materials Science & Engineering. C,... Jan 2021Many drug therapies could be greatly improved by dosage forms that reside in the stomach for prolonged time and release the drug slowly. In this work, therefore,...
Many drug therapies could be greatly improved by dosage forms that reside in the stomach for prolonged time and release the drug slowly. In this work, therefore, slow-release fibrous dosage forms that expand rapidly in the gastric fluid to prevent their passage into the intestines are investigated. The dosage forms consisted of acetaminophen drug and a high-molecular-weight hydroxypropyl methyl cellulose (HPMC) excipient. Upon immersion in a dissolution fluid, they transitioned to viscous, and expanded in proportion to the square-root of time and the reciprocal of fiber radius. The normalized axial expansion was up to 100 percent by fifteen minutes, fast enough to convert a swallowable, 10-mm diameter disk into a gastroretentive, 20-mm diameter viscous gel. The drug was released slowly, eighty percent in 2-8.4 hours. Theoretical models show that the fibrous dosage forms expand rapidly due to the fast diffusion of dissolution fluid into the thin fibers. The fibers then coalesce into a uniform viscous gel, and the diffusion length increases from the radius of the thin fibers to the half-thickness of the gelated dosage form. Consequently, drug diffusion out is slow, and the twin requirements, fast expansion and prolonged drug release, are simultaneously satisfied.
Topics: Delayed-Action Preparations; Dosage Forms; Drug Delivery Systems; Drug Liberation; Excipients; Hypromellose Derivatives; Pharmaceutical Preparations; Solubility; Tablets
PubMed: 33545806
DOI: 10.1016/j.msec.2019.110144 -
Journal of Controlled Release :... Nov 20223D printing in the pharmaceutical and healthcare settings is expanding rapidly, such as the rapid prototyping of orthotics, dental retainers, drug-loaded implants, and... (Review)
Review
3D printing in the pharmaceutical and healthcare settings is expanding rapidly, such as the rapid prototyping of orthotics, dental retainers, drug-loaded implants, and pharmaceutical solid oral dosage forms. Through 3D printing, we have the capability to precisely control dose, release kinetics, and several aesthetic features of dosage forms such as colour, shape, and texture. Additionally, polypills can be created with combinations of medications in one solid dosage form at completely customisable strengths that would be extremely difficult to obtain commercially. As the technology and formulations developed through 3D printing are expanding, the development of new hybrid materials to obtain superior formulations are also gaining momentum. In this review we collate data on the importance of developing hybrid formulations of polymers, drugs and excipients necessary to produce reliable and high-quality 3D printed dosage forms with a special emphasis on fused deposition modelling (FDM). FDM technology is one of the most widely used forms of 3D printing and has demonstrated compatibility with unique polymer-based hybrids to allow for enhanced drug delivery, protection of thermolabile drugs, modifiable release kinetics, and more. The data collated covers different categories of hybrids as well as the methods used to fabricate them, and their respective effects on the properties of 3D printed solid oral dosage forms. Therefore, this review will provide an overview of upcoming and emerging trends in pharmaceutical 3D printing formulation compositions.
Topics: Technology, Pharmaceutical; Drug Liberation; Printing, Three-Dimensional; Excipients; Drug Compounding; Polymers; Dosage Forms; Tablets
PubMed: 36184971
DOI: 10.1016/j.jconrel.2022.09.032 -
Drug Delivery and Translational Research Dec 2018Most of published reviews of twin-screw extrusion focused on its application for enhancing the bioavailability of amorphous solid dispersions while few of them focused... (Review)
Review
Most of published reviews of twin-screw extrusion focused on its application for enhancing the bioavailability of amorphous solid dispersions while few of them focused on its use for manufacturing sustained-release oral dosage forms and medical implants, despite the considerable interest and success this process has garnered both in academia and in the pharmaceutical industry. Compared to conventional batch processing, twin-screw extrusion offers the advantages of continuous processing and the ability to prepare oral dosage forms and medical implants that have unique physicochemical and drug release attributes. This review provides an in-depth analysis of the formulation composition and processing conditions of twin-screw extrusion and how these factors affect the drug release properties of sustained-release dosage forms. This review also illustrates the unique advantages of this process by presenting case studies of a wide variety of commercial sustained-release products manufactured using twin-screw extrusion.
Topics: Administration, Oral; Biological Availability; Delayed-Action Preparations; Drug Compounding; Drug Implants; Drug Liberation; Excipients; Solubility
PubMed: 29235074
DOI: 10.1007/s13346-017-0461-9