-
International Journal of Pharmaceutics Jul 2023Recently, we have shown in dogs that the gastric residence time of expandable fibrous dosage forms can be prolonged by coating the fibers with a semi-permeable,...
Recently, we have shown in dogs that the gastric residence time of expandable fibrous dosage forms can be prolonged by coating the fibers with a semi-permeable, strengthening coating. In this work on pigs, the effect of the volume fraction of the coating, φ, on the expansion, mechanical strength, and gastric residence time is investigated. Three methacrylic acid-ethyl acrylate-coated fibrous dosage forms with φ = 0.025, 0.041, and 0.068 were prepared and tested. Upon administering to a pig, the dosage forms expanded to a normalized radial expansion of 0.5-0.6 in 5, 8, and 10 h, respectively. The expanded dosage forms resided in the stomach and fragmented after 11, 25, and 31 h. The fragments then passed into the intestines and dissolved in 2-3 h. Models suggest that upon contact with gastric fluid, a hydrostatic pressure develops in the fibers due to the inward diffusion of water. The hydrostatic pressure in turn induces a tensile stress in the coating and the dosage form expands. The tensile stress and the expansion rate are inversely proportional to φ. The expanded dosage form eventually fractures due to the loads applied by the contracting stomach walls. The post-expansion mechanical strength and the time to fracture increase steeply with φ. The models predict the experimental results reasonably well. Thus, by increasing φ, dosage form fracture is delayed and the gastric residence time prolonged.
Topics: Animals; Dogs; Swine; Drug Delivery Systems; Delayed-Action Preparations; Stomach; Dosage Forms
PubMed: 36464110
DOI: 10.1016/j.ijpharm.2022.122378 -
International Journal of Biological... Dec 2023The need for biocompatible drug carriers has been significantly increased from the past few years. Researchers show great interest in the development of more versatile... (Review)
Review
The need for biocompatible drug carriers has been significantly increased from the past few years. Researchers show great interest in the development of more versatile and sophisticated biomaterials based drug carriers. Hydrogels are beneficial drug carriers and easily release the controlled amount of drug at target site due to its tunable structure. The hydrogels made-up of potent biological macromolecules including collagen, gelatin, fibrin, elastin, fibroin, chitosan, starch, alginate, agarose and carrageenan have been proven as versatile biomaterials. These are three-dimensional polymeric networks, synthesized by crosslinking of hydrophilic polymers. The biological macromolecules based hydrogels containing therapeutic substances are used in a wide range of biomedical applications including wound healing, tissue engineering, cosmetics and contact lenses. However, many aspects related to hydrogels such as the mechanism of cross-linking and molecular entanglement are not clear. So, there is a need to do more research and exploration toward the extensive and cost-effective use of hydrogels. The present review article elaborately discusses the biomolecules based hydrogels and their possible biomedical applications in different fields.
Topics: Hydrogels; Biocompatible Materials; Drug Carriers; Tissue Engineering; Polymers
PubMed: 37827396
DOI: 10.1016/j.ijbiomac.2023.127362 -
International Journal of Pharmaceutics Aug 2023Optical Coherence Tomography (OCT) has recently gained attention as a promising technology for in-line monitoring of pharmaceutical film-coating processes for...
Optical Coherence Tomography (OCT) has recently gained attention as a promising technology for in-line monitoring of pharmaceutical film-coating processes for (single-layered) tablet coatings and end-point detection with commercial systems. An increasing interest in the investigation of multiparticulate dosage forms with mostly multi-layered coatings below 20 µm final film thickness demands advancement in OCT technology for pharmaceutical imaging. We present an ultra-high-resolution (UHR-) OCT and investigate its performance based on three different multiparticulate dosage forms with different layer structures (one single-layered, two multi-layered) with layer thicknesses in a range from 5 to 50 µm. The achieved system resolution of 2.4 µm (axial) and 3.4 µm (lateral, both in air) enables the assessment of defects, film thickness variability and morphological features within the coating, previously unattainable using OCT. Despite the high transverse resolution, the provided depth of field was found sufficient to reach the core region of all dosage forms under test. We further demonstrate an automated segmentation and evaluation of UHR-OCT images for coating thicknesses, where human experts struggle using today's standard OCT systems.
Topics: Humans; Tomography, Optical Coherence; Tablets; Surface Properties
PubMed: 37268027
DOI: 10.1016/j.ijpharm.2023.123096 -
Small Methods Jan 2024Nowadays, smart hydrogels are being widely studied by researchers because of their advantages such as simple preparation, stable performance, response to external... (Review)
Review
Nowadays, smart hydrogels are being widely studied by researchers because of their advantages such as simple preparation, stable performance, response to external stimuli, and easy control of response behavior. Photo-controllable smart hydrogels (PCHs) are a class of responsive hydrogels whose physical and chemical properties can be changed when stimulated by light at specific wavelengths. Since the light source is safe, clean, simple to operate, and easy to control, PCHs have broad application prospects in the biomedical field. Therefore, this review timely summarizes the latest progress in the PCHs field, with an emphasis on the design principles of typical PCHs and their multiple biomedical applications in tissue regeneration, tumor therapy, antibacterial therapy, diseases diagnosis and monitoring, etc. Meanwhile, the challenges and perspectives of widespread practical implementation of PCHs are presented in biomedical applications. This study hopes that PCHs will flourish in the biomedical field and this review will provide useful information for interested researchers.
Topics: Hydrogels; Anti-Bacterial Agents; Drug Delivery Systems
PubMed: 37884456
DOI: 10.1002/smtd.202301095 -
Journal of Advanced Nursing Apr 2024To appraise and synthesize research investigating optimizing the administration of solid oral dosage forms (SODFs) to adults with swallowing difficulties. (Review)
Review
AIM
To appraise and synthesize research investigating optimizing the administration of solid oral dosage forms (SODFs) to adults with swallowing difficulties.
DESIGN
An integrative review.
METHODS
An electronic search was conducted on Medical Literature Analysis and Retrieval System Online (Public Medline interface), Elsevier SciVerse Scopus and Scientific Electronic Library Online (updated February 2023). Restriction regarding the publication date was not considered for the inclusion of records. Studies addressing risks, general aspects, recommendations about patient postural adjustments, swallowing techniques, swallowing aids and aspects of concealment of SODFs were included.
RESULTS
Fifty-three records published between 2002 and 2021 were included. The main administration risks were aspiration, asphyxia and solid oral dosage form-induced oral/oesophageal mucosal lesions. The most frequent general aspect reported was administering one oral dosage form at a time. The sitting position was the most patient postural adjustment mentioned. The most frequently reported solid oral dosage form swallowing technique was the lean-forward method for capsules. Solid oral dosage form swallowing aids cited: tongue and throat lubricant and solid oral dosage form coating device, swallowing cup and swallowing straw.
CONCLUSION
The literature data on administering SODFs for adults with swallowing difficulties were appraised and synthesized. Some aspects, for example, not administering SODFs simultaneously, can make swallowing safer. Postural adjustments and solid oral dosage form swallowing aids are important to avoid administration risks. Swallowing SODFs can be easier if learned by techniques. Liquid and food are helpful as vehicles, and several of these have been listed.
IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE
By optimizing the contributing factors of administering oral pharmacotherapy, the nurse can use appropriate practices to improve patient safety. Additionally, knowing and establishing the administration aspects are reasonable steps for standardizing care for patients with swallowing oral dosage form difficulties.
IMPACT
This study addressed administering SODFs to adult patients with swallowing difficulties. The administration of SODFs to adult patients with swallowing difficulties can be optimized if only one oral dosage form at a time is administrated and if patient postural adjustments, swallowing techniques and swallowing aids are used. This investigation will impact the care of patients with swallowing difficulties.
REPORTING METHOD
The authors declare they adhered to the relevant EQUATOR guidelines and report following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 Statement.
PATIENT OR PUBLIC CONTRIBUTION
No patient or public contribution.
Topics: Humans; Administration, Oral; Capsules; Deglutition; Deglutition Disorders
PubMed: 37908152
DOI: 10.1111/jan.15910 -
Macromolecular Bioscience May 2024Sustainable and controllable drug transport is one of the most efficient ways of disease treatment. Due to high biocompatibility, good biodegradability, and low costs,... (Review)
Review
Sustainable and controllable drug transport is one of the most efficient ways of disease treatment. Due to high biocompatibility, good biodegradability, and low costs, chitosan and its derivatives are widely used in biomedical fields. Specifically, chitosan hydrogel enables drugs to pass through biological barriers because of their abundant amino and hydroxyl groups that can interact with human tissues. Moreover, the multi-responsive nature (pH, temperature, ions strength, and magnetic field, etc.) of chitosan hydrogels makes precise drug release a possibility. Here, the synthesis methods, modification strategies, stimuli-responsive mechanisms of chitosan-based hydrogels, and their recent progress in drug delivery are summarized. Chitosan hydrogels that carry and release drugs through subcutaneous (dealing with wound dressing), oral (dealing with gastrointestinal tract), and facial (dealing with ophthalmic, ear, and brain) are reviewed. Finally, challenges toward clinic application and the future prospects of stimuli-responsive chitosan-based hydrogels are indicated.
Topics: Chitosan; Hydrogels; Humans; Drug Delivery Systems; Animals; Drug Carriers; Drug Liberation; Hydrogen-Ion Concentration
PubMed: 38011585
DOI: 10.1002/mabi.202300399 -
Food Chemistry Sep 2023Natural protein-based delivery systems have received special interest over the last few years. Different carriers are already developed in the food industry to protect,... (Review)
Review
Natural protein-based delivery systems have received special interest over the last few years. Different carriers are already developed in the food industry to protect, encapsulate and deliver bioactive compounds. Rice bran protein (RBP) is currently used as a carrier in encapsulating bioactives due to its excellent functional properties, great natural value, low price, good biodegradability, and biocompatibility. Recently, RBP-based carriers including emulsions, microparticles, nanoparticles, nanoemulsions, liposomes, and core-shell structures have been studied extensively in the literature. This study reviews the important characteristics of RBP in developing bioactive delivery systems. The recent progress in various modification approaches for improving RBP properties as carriers along with different types of RBP-based bioactive delivery systems is discussed. In the final part, the bioavailability and release profiles of bioactives from RBP-based carriers and the recent developments are described.
Topics: Oryza; Proteins; Emulsions; Liposomes; Food-Processing Industry
PubMed: 37086611
DOI: 10.1016/j.foodchem.2023.136121 -
Journal of AOAC International Nov 2023Evogliptin tartrate is a novel dipeptidyl peptidase (DPP-4) inhibitor very recently introduced into the market as an oral hypoglycemic drug.
BACKGROUND
Evogliptin tartrate is a novel dipeptidyl peptidase (DPP-4) inhibitor very recently introduced into the market as an oral hypoglycemic drug.
OBJECTIVE
The literature review has revealed no reports of stability-indicating analytical methods so far for evogliptin tartrate. Thus, the goal of this study was to develop and validate a stability-indicating high-performance thin-layer chromatography (HPTLC) method for evogliptin tartrate in bulk and tablet dosage form.
METHOD
For the study, precoated plates of silica gel 60F254 were used as stationary phase and acetonitrile-water-formic acid (30:8:2, v/v/v) was used as a developing system. The densitometric scanning was performed at 270 nm, and the method was validated as per International Council for Harmonisation (ICH) guidelines for accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ). Evogliptin was subjected to forced degradation studies and was exposed to various stress conditions such as acid/base hydrolysis, oxidation, thermal stress, and UV light.
RESULTS
The developed method furnished compact spots of evogliptin (Rf 0.62 ± 0.05) and was linear in the concentration range of 1-5 µg/spot. The lowest detection and quantitation values were found to be 0.331 and 1.003 µg/spot, respectively, and % recovery was found to be 101.09. The low RSD values (below 2%) for intra-day (% RSD 1.86) and inter-day (% RSD 1.43) precision studies demonstrated the preciseness of the developed method.
CONCLUSIONS
All the validation parameters were found to be within the acceptable range prescribed by ICH guidelines, indicating that the developed method was accurate, precise, selective, and reproducible. A total of five degradation products were resolved under various stress conditions.
HIGHLIGHTS
The proposed method has a promising application commercially for identification, routine quantitative determination, and monitoring of stability of the evogliptin tartrate in bulk and tablet dosage forms to guarantee its safety, efficacy, and quality. Moreover, the developed method will also help in formulation development and in determining the appropriate storage conditions.
Topics: Drug Stability; Tartrates; Tablets; Chromatography, Thin Layer
PubMed: 37531285
DOI: 10.1093/jaoacint/qsad091 -
Advances in Colloid and Interface... Dec 2023Inspired by natural catalytic compartments, various synthetic compartments that seclude catalytic reactions have been developed to understand complex multistep... (Review)
Review
Inspired by natural catalytic compartments, various synthetic compartments that seclude catalytic reactions have been developed to understand complex multistep biosynthetic pathways, bestow therapeutic effects, or extend biosynthetic pathways in living cells. These emerging nanoreactors possessed many advantages over conventional biomedicine, such as good catalytic activity, specificity, and sustainability. In the past decade, a great number of efficient catalytic systems based on diverse nanoreactors (polymer vesicles, liposome, polymer micelles, inorganic-organic hybrid materials, MOFs, etc.) have been designed and employed to initiate in situ catalyzed chemical reactions for therapy. This review aims to present the recent progress in the development of catalytic systems based on nanoreactors for therapeutic applications, with a special emphasis on the principles and design strategies. Besides, the key components of nanoreactor-based catalytic systems, including nanocarriers, triggers or energy inputs, and products, are respectively introduced and discussed in detail. Challenges and prospects in the fabrication of therapeutic catalytic nanoreactors are also discussed as a conclusion to this review. We believe that catalytic nanoreactors will play an increasingly important role in modern biomedicine, with improved therapeutic performance and minimal side effects.
Topics: Catalysis; Liposomes; Polymers; Micelles; Nanotechnology
PubMed: 37931381
DOI: 10.1016/j.cis.2023.103037 -
International Journal of Pharmaceutics Aug 2023The plasticity of materials plays a critical role in adequate powder tabletability, which is required in developing a successful tablet product. Generally, a more...
The plasticity of materials plays a critical role in adequate powder tabletability, which is required in developing a successful tablet product. Generally, a more plastic material can develop larger bonding areas when other factors are the same, leading to higher tabletability than less plastic materials. However, it was observed that, for a solid form of a compound with poorer tabletability, a mixture with microcrystalline cellulose (MCC) can actually exhibit better tabletability, a phenomenon termed tabletability flip. Hence, there is a chance that a solid form with poor tabletability could have been erroneously eliminated based on the expected tabletability challenges during tablet manufacturing. This study was conducted to investigate the generality of this phenomenon using two polymorph pairs, a salt and free acid pair, a crystalline and amorphous solid dispersion pair, and a pair of chemically distinct crystals. Results show that tabletability flip occurred in all six systems tested, including five pairs of binary mixtures with MCC and one pair in a realistic generic tablet formulation, suggesting the broad occurrence of the tabletability flip phenomenon, where both compaction pressure and the difference in plasticity between the pair of materials play important roles.
Topics: Drug Compounding; Tablets; Powders; Tensile Strength
PubMed: 37495026
DOI: 10.1016/j.ijpharm.2023.123262