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18 pages, 13576 KiB

Open AccessArticle

Hybrid 3D-Printed and Electrospun Scaffolds Loaded with Dexamethasone for Soft Tissue Applications

by Silvia Pisani, Valeria Mauri, Erika Negrello, Valeria Friuli, Ida Genta, Rossella Dorati, Giovanna Bruni, Stefania Marconi, Ferdinando Auricchio, Andrea Pietrabissa, Marco Benazzo and Bice Conti

Pharmaceutics 2023, 15(10), 2478; https://doi.org/10.3390/pharmaceutics15102478 - 17 Oct 2023

Viewed by 921

Abstract

Background: To make the regenerative process more effective and efficient, tissue engineering (TE) strategies have been implemented. Three-dimensional scaffolds (electrospun or 3D-printed), due to their suitable designed architecture, offer the proper location of the position of cells, as well as cell adhesion and [...] Read more.

Background: To make the regenerative process more effective and efficient, tissue engineering (TE) strategies have been implemented. Three-dimensional scaffolds (electrospun or 3D-printed), due to their suitable designed architecture, offer the proper location of the position of cells, as well as cell adhesion and the deposition of the extracellular matrix. Moreover, the possibility to guarantee a concomitant release of drugs can promote tissue regeneration. Methods: A PLA/PCL copolymer was used for the manufacturing of electrospun and hybrid scaffolds (composed of a 3D-printed support coated with electrospun fibers). Dexamethasone was loaded as an anti-inflammatory drug into the electrospun fibers, and the drug release kinetics and scaffold biological behavior were evaluated. Results: The encapsulation efficiency (EE%) was higher than 80%. DXM embedding into the electrospun fibers resulted in a slowed drug release rate, and a slower release was seen in the hybrid scaffolds. The fibers maintained their nanometric dimensions (less than 800 nm) even after deposition on the 3D-printed supports. Cell adhesion and proliferation was favored in the DXM-loading hybrid scaffolds. Conclusions: The hybrid scaffolds that were developed in this study can be optimized as a versatile platform for soft tissue regeneration. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form, 2nd Edition)

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20 pages, 4349 KiB

Open AccessArticle

Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation

by Irma Elisa Cupone, Giuliana Roselli, Fabio Marra, Marika Riva, Silvia Angeletti, Laura Dugo, Silvia Spoto, Marta Fogolari and Andrea Maria Giori

Pharmaceutics 2023, 15(6), 1575; https://doi.org/10.3390/pharmaceutics15061575 - 23 May 2023

Cited by 1 | Viewed by 1411

Abstract

Orodispersible film (ODF) is an innovative dosage form used to administer drugs and nutrients, designed to disintegrate or dissolve in the oral cavity without needing water. One of the advantages of ODF is that it is suitable for administration in older people and [...] Read more.

Orodispersible film (ODF) is an innovative dosage form used to administer drugs and nutrients, designed to disintegrate or dissolve in the oral cavity without needing water. One of the advantages of ODF is that it is suitable for administration in older people and children who have difficulty swallowing because of psychological or physiological deficiencies. This article describes the development of an ODF based on maltodextrin, which is easy to administer, has a pleasant taste, and is suitable for iron supplementation. An ODF containing 30 mg of iron as pyrophosphate and 400 µg of folic acid (iron ODF) was developed and manufactured on an industrial scale. The kinetic profile for serum iron and folic acid upon consumption of ODF compared with a Sucrosomial^® iron capsule (known for its high bioavailability) was evaluated in a crossover clinical trial. The study was conducted in nine healthy women, and the serum iron profile (AUC_0–8, T_max, and C_max) of both formulations was defined. Results showed that the rate and extent of elemental iron absorption with iron ODF was comparable to that obtained using the Sucrosomial^® iron capsule. These data represent the first evidence of iron and folic acid absorption concerning the newly developed ODF. Iron ODF was proven to be a suitable product for oral iron supplementation. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form, 2nd Edition)

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22 pages, 4678 KiB

Open AccessArticle

Influence of Solid Oral Dosage Form Characteristics on Swallowability, Visual Perception, and Handling in Older Adults

by Henriette Hummler, Susanne Page, Cordula Stillhart, Lisa Meilicke, Michael Grimm, Marwan Mannaa, Maik Gollasch and Werner Weitschies

Pharmaceutics 2023, 15(4), 1315; https://doi.org/10.3390/pharmaceutics15041315 - 21 Apr 2023

Cited by 2 | Viewed by 2294

Abstract

Swallowability, visual perception, and any handling to be conducted prior to use are all influence factors on the acceptability of an oral dosage form by the patient. Knowing the dosage form preferences of older adults, as the major group of medication end users, [...] Read more.

Swallowability, visual perception, and any handling to be conducted prior to use are all influence factors on the acceptability of an oral dosage form by the patient. Knowing the dosage form preferences of older adults, as the major group of medication end users, is needed for patient-centric drug development. This study aimed at evaluating the ability of older adults to handle tablets as well as to assess the anticipated swallowability of tablets, capsules, and mini tablets based on visual perception. The randomized intervention study included 52 older adults (65 to 94 years) and 52 younger adults (19 to 36 years). Within the tested tablets, ranging from 125 mg up to 1000 mg in weight and being of different shapes, handling was not seen as the limiting factor for the decision on appropriate tablet size. However, the smallest sized tablets were rated worst. According to visual perception, the limit of acceptable tablet size was reached at around 250 mg for older adults. For younger adults, this limit was shifted to higher weights and was dependent on the tablet shape. Differences in anticipated swallowability with respect to tablet shapes were most pronounced for tablets of 500 mg and 750 mg in weight, independent of the age category. Capsules performed worse compared to tablets, while mini tablets appeared as a possible alternative dosage form to tablets of higher weight. Within the deglutition part of this study, swallowability capabilities of the same populations were assessed and have been reported previously. Comparing the present results with the swallowing capabilities of the same populations with respect to tablets, it shows adults’ clear self-underestimation of their ability to swallow tablets independent of their age. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form, 2nd Edition)

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20 pages, 11532 KiB

Open AccessArticle

Impact of Tablet Size and Shape on the Swallowability in Older Adults

by Henriette Hummler, Cordula Stillhart, Lisa Meilicke, Michael Grimm, Elischa Krause, Marwan Mannaa, Maik Gollasch, Werner Weitschies and Susanne Page

Pharmaceutics 2023, 15(4), 1042; https://doi.org/10.3390/pharmaceutics15041042 - 23 Mar 2023

Cited by 6 | Viewed by 3823

Abstract

Older adults represent the major target population for oral medications, due to the high prevalence of multimorbidity. To allow for successful pharmacological treatments, patients need to adhere to their medication and, thus, patient-centric drug products with a high level of acceptability by the [...] Read more.

Older adults represent the major target population for oral medications, due to the high prevalence of multimorbidity. To allow for successful pharmacological treatments, patients need to adhere to their medication and, thus, patient-centric drug products with a high level of acceptability by the end users are needed. However, knowledge on the appropriate size and shape of solid oral dosage forms, as the most commonly used dosage forms in older adults, is still scarce. A randomized intervention study was performed including 52 older adults (65 to 94 years) and 52 young adults (19 to 36 years). Each participant swallowed four coated placebo tablets differing in weight (250 to 1000 mg) and shape (oval, round, oblong) in a blinded manner on three study days. The choice of tablet dimensions allowed for a systematic comparison between different tablet sizes of the same shape, as well as between different tablet shapes. Swallowability was assessed using a questionnaire-based method. All tested tablets were swallowed by ≥80% of adults, independent of age. However, only the 250 mg oval tablet was classified as well swallowable by ≥80% of old participants. The same was true for young participants; however, they also considered the 250 mg round and the 500 mg oval tablet as well swallowable. Furthermore, swallowability was seen to influence the willingness to take a tablet on a daily basis, especially for an intake over longer time periods. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form, 2nd Edition)

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19 pages, 4093 KiB

Open AccessArticle

Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics

by Nicole Fülöpová, Natália Chomová, Jan Elbl, Dagmar Mudroňová, Patrik Sivulič, Sylvie Pavloková and Aleš Franc

Pharmaceutics 2023, 15(3), 910; https://doi.org/10.3390/pharmaceutics15030910 - 10 Mar 2023

Cited by 1 | Viewed by 1825

Abstract

Probiotics have been used in human and veterinary medicine to increase resistance to pathogens and provide protection against external impacts for many years. Pathogens are often transmitted to humans through animal product consumption. Therefore, it is assumed that probiotics protecting animals may also [...] Read more.

Probiotics have been used in human and veterinary medicine to increase resistance to pathogens and provide protection against external impacts for many years. Pathogens are often transmitted to humans through animal product consumption. Therefore, it is assumed that probiotics protecting animals may also protect the humans who consume them. Many tested strains of probiotic bacteria can be used for individualized therapy. The recently isolated Lactobacillus plantarum R2 Biocenol™ has proven to be preferential in aquaculture, and potential benefits in humans are expected. A simple oral dosage form should be developed to test this hypothesis by a suitable preparation method, i.e., lyophilization, allowing the bacteria to survive longer. Lyophilizates were formed from silicates (Neusilin^® NS2N; US2), cellulose derivates (Avicel^® PH-101), and saccharides (inulin; saccharose; modified starch^® 1500). They were evaluated for their physicochemical properties (pH leachate, moisture content, water absorption, wetting time, DSC tests, densities, and flow properties); their bacterial viability was determined in conditions including relevant studies over 6 months at 4 °C and scanned under an electron microscope. Lyophilizate composed of Neusilin^® NS2N and saccharose appeared to be the most advantageous in terms of viability without any significant decrease. Its physicochemical properties are also suitable for capsule encapsulation, subsequent clinical evaluation, and individualized therapy. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form, 2nd Edition)

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9 pages, 1000 KiB

Open AccessArticle

Comparison of Bitterness Intensity between Prednisolone and Quinine in a Human Sensory Test Indicated Individual Differences in Bitter-Taste Perception

by Mengyan Deng, Noriko Hida, Taigi Yamazaki, Ryo Morishima, Yuka Kato, Yoshiaki Fujita, Akihiro Nakamura and Tsutomu Harada

Pharmaceutics 2022, 14(11), 2454; https://doi.org/10.3390/pharmaceutics14112454 - 14 Nov 2022

Cited by 3 | Viewed by 2075

Abstract

Prednisolone is a frequently prescribed steroid with a bitter, unpalatable taste that can result in treatment refusal. Oral suspensions or powder dosage forms are often prescribed, particularly to pediatric patients, as they improve swallowability and ease of dose adjustment. Consequently, the bitterness of [...] Read more.

Prednisolone is a frequently prescribed steroid with a bitter, unpalatable taste that can result in treatment refusal. Oral suspensions or powder dosage forms are often prescribed, particularly to pediatric patients, as they improve swallowability and ease of dose adjustment. Consequently, the bitterness of prednisolone is more apparent in these dosage forms. Few studies have investigated prednisolone’s bitterness. Thus, in this study, 50 adults evaluated the bitterness of prednisolone using the generalized Labeled Magnitude Scale (gLMS), in comparison with quinine, a standard bitter substance. Overall, prednisolone-saturated solution demonstrated the same extent (mean gLMS score: 46.8) of bitterness as 1 mM quinine solution (mean gLMS score: 40.1). Additionally, large individual differences were observed in the perception of the bitterness of prednisolone and quinine. Perceived flavors of some drugs are reportedly associated with bitter-taste receptor (TAS2Rs) polymorphisms. Therefore, we investigated the relationship between subjects’ genetic polymorphisms of TAS2R19, 38, and 46, and their sensitivity to bitterness. Although a relationship between TAS2R19 polymorphisms and the perception of quinine bitterness was observed, no significant relationship was found between the perceived bitterness of prednisolone and the investigated genes. Ultimately, the results show that despite individual differences among subjects, the cause of prednisolone’s strong bitterness is yet to be elucidated. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form, 2nd Edition)

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Review

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19 pages, 1019 KiB

Open AccessEditor’s ChoiceReview

Colour of Medicines and Children’s Acceptability? A Systematic Literature Review of Children’s Perceptions about Colours of Oral Dosage Forms

by Elisa Alessandrini, Milena Gonakova, Hannah Batchelor, Sveinbjorn Gizurarson, Sonia Iurian, Sandra Klein, Daniel Schaufelberger, Roy Turner, Jennifer Walsh and Catherine Tuleu

Pharmaceutics 2023, 15(7), 1992; https://doi.org/10.3390/pharmaceutics15071992 - 20 Jul 2023

Cited by 2 | Viewed by 1721

Abstract

The colour of a product plays an important role in consumer experiences, and in the context of pharmaceutical products, this could potentially affect a patient’s expectations, behaviours, and adherence. Several studies have been conducted on adults, but little is known about children’s opinions [...] Read more.

The colour of a product plays an important role in consumer experiences, and in the context of pharmaceutical products, this could potentially affect a patient’s expectations, behaviours, and adherence. Several studies have been conducted on adults, but little is known about children’s opinions on colours of medicines and to what extent medicines’ colour affects their acceptability. To address this gap, a systematic search in PubMed, Scopus, MEDLINE, and Web of Science was conducted. Two authors independently screened the titles, abstracts, and references of all articles and selected studies conducted on children (0–18 years old), assessing children’s preferences or opinions about colour of oral dosage forms as either a primary or secondary objective or as an anecdotal record. A total of 989 publications were identified and, after screening, 18 publications were included in the review. Red and pink were the most liked colours and there appeared to be a relationship between the colour of a medicine and expected taste/flavour. The review also highlighted a scarcity of information, usually collected as an anecdotal record. Several gaps in the current knowledge were underlined, emphasizing the need of patient-centred studies to understand if the use of certain colours can improve or worsen the acceptability of a paediatric medicine. This will help inform pharmaceutical manufacturers and regulators on the role and need of colours in children’s medicines beyond quality purposes. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form, 2nd Edition)

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19 pages, 329 KiB

Open AccessReview

Meeting Challenges of Pediatric Drug Delivery: The Potential of Orally Fast Disintegrating Tablets for Infants and Children

by Klervi Golhen, Michael Buettcher, Jonas Kost, Jörg Huwyler and Marc Pfister

Pharmaceutics 2023, 15(4), 1033; https://doi.org/10.3390/pharmaceutics15041033 - 23 Mar 2023

Cited by 3 | Viewed by 2909

Abstract

A majority of therapeutics are not available as suitable dosage forms for administration to pediatric patients. The first part of this review provides an overview of clinical and technological challenges and opportunities in the development of child-friendly dosage forms such as taste masking, [...] Read more.

A majority of therapeutics are not available as suitable dosage forms for administration to pediatric patients. The first part of this review provides an overview of clinical and technological challenges and opportunities in the development of child-friendly dosage forms such as taste masking, tablet size, flexibility of dose administration, excipient safety and acceptability. In this context, developmental pharmacology, rapid onset of action in pediatric emergency situations, regulatory and socioeconomic aspects are also reviewed and illustrated with clinical case studies. The second part of this work discusses the example of Orally Dispersible Tablets (ODTs) as a child-friendly drug delivery strategy. Inorganic particulate drug carriers can thereby be used as multifunctional excipients offering a potential solution to address unique medical needs in infants and children while maintaining a favorable excipient safety and acceptability profile in these vulnerable patient populations. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form, 2nd Edition)

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