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  • 1.
    Morales, Javier O.
    et al.
    Department of Pharmaceutical Science and Technology, School of Chemical and Pharmaceutical Sciences, University of Chile, Santiago .
    Huang, Siyuan
    College of Pharmacy, The University of Texas at Austin, Austin, TX .
    Williams, Robert O
    College of Pharmacy, The University of Texas at Austin, Austin, TX.
    McConville, Jason T
    cCollege of Pharmacy, University of New Mexico, Albuquerque, NM .
    Films loaded with insulin-coated nanoparticles (ICNP) as potential platforms for peptide buccal delivery2014In: Colloids and Surfaces B: Biointerfaces, ISSN 0927-7765, E-ISSN 1873-4367, Vol. 122, p. 38-45Article in journal (Refereed)
    Abstract [en]

    The goal of this investigation was to develop films containing insulin-coated nanoparticles and evaluate their performance in vitro as potential peptide delivery systems. To incorporate insulin into the films, a new antisolvent co-precipitation fabrication process was adapted to obtain insulin-coated nanoparticles (ICNPs). The ICNPs were embedded in polymeric films containing a cationic polymethacrylate derivative (ERL) or a combination of ERL with hydroxypropyl methylcellulose (HPMC). ICNP-loaded films were characterized for morphology, mucoadhesion, and insulin release. Furthermore, in vitro insulin permeation was evaluated using a cultured tridimensional human buccal mucosa model. The antisolvent co-precipitation method was successfully adapted to obtain ICNPs with 40% (w/w) insulin load, achieving 323±8nm particles with a high zeta potential of 32.4±0.8mV, indicating good stability. High yields were obtained after manufacture and the insulin content did not decrease after one month storage. ICNP-embedded films using ERL as the polymer matrix presented excellent mucoadhesive and insulin release properties. A high permeation enhancement effect was observed for ICNP-loaded ERL films in comparison with ICNP-loaded ERL-HPMC films and a control insulin solution. ICNP-loaded ERL formulations were found to be more effective in terms of film performance and insulin permeation through the human buccal mucosa model, and thus are a promising delivery system for buccal administration of a peptide such as insulin.

  • 2.
    Morales, Javier O.
    et al.
    College of Pharmacy, University of Texas at Austin .
    Joks, Gero M
    bPharmazeutischeTechnologie, Pharmazeutisches Institut der Universität Bonn.
    Lamprecht, Alf
    bPharmazeutischeTechnologie, Pharmazeutisches Institut der Universität Bonn.
    Ross, Alistair C
    Controlled Therapeutics (Scotland) Ltd.
    McConville, Jason T
    College of Pharmacy, University of Texas at Austin.
    A design of experiments to optimize a new manufacturing process for high activity protein-containing submicron particles2013In: Drug Development and Industrial Pharmacy, ISSN 0363-9045, E-ISSN 1520-5762, Vol. 39, no 11, p. 1793-1801Article in journal (Refereed)
    Abstract [en]

    A novel method for the manufacture of protein/peptide-containing submicron particles was developed in an attempt to provide particles with increased activity while using high energy input technologies. The method consists of antisolvent co-precipitation from an aqueous solution containing both an amino acid core material (e.g. D,L-valine), and either bovine serum albumin (BSA) or lysozyme (Lys) as model proteins. The aqueous solution was added to the organic phase by means of a nebulizer to increase the total surface area of interaction for the precipitation process. Sonication proved to be an effective method to produce small particle sizes while maintaining high activity of Lys. The use of a polysorbate or sorbitan ester derivatives as stabilizers proved to be necessary to yield submicron particles. Particles with very high yields (approximately 100%) and very high activity after manufacture (approximately 100%) could be obtained. A particle size of 439.0 nm, with a yield of 48.8% and with final remaining activity of 98.7% was obtained. By studying various factors using a design of experiments strategy (DoE) we were able to establish the critical controlling factors for this new method of manufacture.

  • 3.
    Morales, Javier O.
    et al.
    College of Pharmacy, University of Texas at Austin.
    McConville, Jason T
    College of Pharmacy, University of Texas at Austin.
    Manufacture and characterization of mucoadhesive buccal films2011In: European journal of pharmaceutics and biopharmaceutics, ISSN 0939-6411, E-ISSN 1873-3441, Vol. 77, no 2, p. 187-199Article in journal (Refereed)
    Abstract [en]

    The buccal route of administration has a number of advantages including bypassing the gastrointestinal tract and the hepatic first pass effect. Mucoadhesive films are retentive dosage forms and release drug directly into a biological substrate. Furthermore, films have improved patient compliance due to their small size and reduced thickness, compared for example to lozenges and tablets. The development of mucoadhesive buccal films has increased dramatically over the past decade because it is a promising delivery alternative to various therapeutic classes including peptides, vaccines, and nanoparticles. The "film casting process" involves casting of aqueous solutions and/or organic solvents to yield films suitable for this administration route. Over the last decade, hot-melt extrusion has been explored as an alternative manufacturing process and has yielded promising results. Characterization of critical properties such as the mucoadhesive strength, drug content uniformity, and permeation rate represent the major research areas in the design of buccal films. This review will consider the literature that describes the manufacture and characterization of mucoadhesive buccal films.

  • 4.
    Morales, Javier O.
    et al.
    Department of Pharmaceutical Science and Technology, School of Chemical and Pharmaceutical Sciences, University of Chile.
    McConville, Jason T
    College of Pharmacy, University of New Mexico, Albuquerque, NM.
    Novel strategies for the buccal delivery of macromolecules2014In: Drug Development and Industrial Pharmacy, ISSN 0363-9045, E-ISSN 1520-5762, Vol. 40, no 5, p. 579-590Article in journal (Refereed)
    Abstract [en]

    For years now, the delivery of small molecules through the buccal mucosal route has been described in the literature, but it has only been over the past decade that investigations into macromolecule delivery via the buccal route have sharply increased. The administration of macromolecules such as proteins and peptides, antibodies, or nucleic acids by buccal administration would be greatly enhanced due to the avoidance of the gastrointestinal conditions, rapid uptake into systemic circulation, as well as the potential for controlled drug delivery. Since macromolecules are faced with a number of specific challenges related to permeation through the epithelium, several strategies have been employed historically to improve their buccal absorption and subsequent bioavailability. Several conventional strategies to improve macromolecule penetration include the use of chemical permeation enhancers, enzyme inhibitors and the use of mucoadhesive materials acting as carriers. More recent approaches include the incorporation of the macromolecule as part of nanostructured delivery systems to further enhance targeting and delivery. This review focuses on the different permeation enhancing strategies as well as formulation design that are tailored to meet the challenges of active macromolecule delivery using the buccal mucosal route of administration.

  • 5.
    Morales, Javier O.
    et al.
    Department of Pharmaceutical Sciences and Technology, University of Chile.
    McConville, Jason T
    College of Pharmacy, University of New Mexico, Albuquerque, NM.
    Preface for buccal drug delivery theme issue2014In: Drug Development and Industrial Pharmacy, ISSN 0363-9045, E-ISSN 1520-5762, Vol. 40, no 5, p. 577-578Article in journal (Refereed)
    Abstract [en]

    During the past years, buccal drug delivery has attracted the attention of researchers looking for alternative delivery routes of administration. As an alternative to oral drug delivery, the buccal mucosal route avoids the passage through the acidic gastric environment, intestinal and bacterial enzymatic activity, absorption issues associated with the intestinal epithelium (e.g. P-glycoprotein efflux), and the first pass metabolism of the liver. Therefore, the buccal route could be a good delivery route for macromolecules and other drugs not compatible with the gastrointestinal tract environment. This "Buccal Drug Delivery" special edition of Drug Development and Industrial Pharmacy aims to bring together a range of different aspects relevant to the growing field of buccal drug delivery. The special edition includes thorough reviews of the literature, as well as original research articles touching on most prominent features related to buccal drug delivery systems, such as the move toward the use of nanotechnology in different ways to facilitate buccal drug delivery with the potential to prompt future product developments.

  • 6.
    Morales, Javier O.
    et al.
    Division of Pharmaceutics, College of Pharmacy, University of Texas at Austin.
    Peters, Jay I.
    Department of Pulmonary Care, College of Medicine, University of Texas Health Science Center at San Antonio.
    Williams, Robert O
    Division of Pharmaceutics, College of Pharmacy, University of Texas at Austin.
    Surfactants: their critical role in enhancing drug delivery to the lungs2011In: Therapeutic delivery, ISSN 2041-5990, E-ISSN 2041-6008, Vol. 2, no 5, p. 623-641Article in journal (Refereed)
    Abstract [en]

    For local lung conditions and diseases, pulmonary drug delivery has been widely used for more than 50 years now. A more recent trend involves the pulmonary route as a systemic drug-delivery target. Advantages such as avoidance of the gastrointestinal environment, different enzyme content compared with the intestine, and avoidance of first-pass metabolism make the lung an alternative route for the systemic delivery of actives. However, the lung offers barriers to absorption such as a surfactant layer, epithelial surface lining fluid, epithelial monolayer, interstitium and basement membrane, and capillary endothelium. Many delivery strategies have been developed in order to overcome these limitations. The use of surfactants is one of these approaches and their role in enhancing pulmonary drug delivery is reviewed in this article. A systematic review of the literature relating to the effect of surfactants on formulations for pulmonary delivery was conducted. Specifically, research reporting enhancement of in vivo performance was focused on. The effect of the addition of surfactants such as phospholipids, bile salts, non-ionic, fatty acids, and liposomes as phospholipid-containing carriers on the enhancement of therapeutic outcomes of drugs for pulmonary delivery was compiled. The main use attributed to surfactants in pulmonary drug delivery is as absorption enhancers by mechanisms of action not yet fully understood. Furthermore, surfactants have been used to improve the delivery of inhaled drugs in various additional strategies discussed herein.

  • 7.
    Morales, Javier O.
    et al.
    Luleå University of Technology, Department of Health Sciences, Medical Science. College of Pharmacy, University of Texas at Austin.
    Ross, Alistair C
    Ferring Controlled Therapeutics Ltd.
    McConville, Jason T
    University of New Mexico.
    Protein-coated nanoparticles embedded in films as delivery platforms2013In: Journal of Pharmacy and Pharmacology (JPP), ISSN 0022-3573, E-ISSN 2042-7158, Vol. 65, no 6, p. 827-838Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: This work aimed to evaluate the performance of nanoparticle-loaded films based on matrices of polymethacrylates and hydroxypropylmethylcellulose (HPMC) intended for delivery of macromolecules.

    METHODS: Lysozyme (Lys)-loaded nanoparticles were manufactured by antisolvent co-precipitation. After size, loading efficiency and stability characterization, the selected batch of particles was further formulated into films. Films were characterized for mechanical properties, mucoadhesion, Lys release and activity after manufacture.

    KEY FINDINGS: We found that protein-coated nanoparticles could be obtained in USP phosphate buffer pH 6.8. Particles obtained at pH 6.8 had a z-average of 347.2 nm, a zeta-potential of 21.9 mV and 99.2% remaining activity after manufacture. This formulation was further studied for its application in films for buccal delivery. Films loaded with nanoparticles that contained Eudragit RLPO (ERL) exhibited excellent mechanical and mucoadhesive properties. Due to its higher water-swelling and solubility compared with ERL, the use of HPMC allowed us to tailor the release of Lys from films. The formulation composed of equal amounts of ERL and HPMC revealed a sustained release over 4 h, with Lys remaining fully active at the end of the study.

    CONCLUSIONS: Mucoadhesive films containing protein-coated nanoparticles are promising carriers for the buccal delivery of proteins and peptides in a stable form.

  • 8.
    Morales, Javier O.
    et al.
    Department of Pharmaceutical Sciences and Technology, University of Chile.
    Sepulveda-Rivas, Sabrina
    Department of Pharmaceutical Sciences and Technology, University of Chile.
    Oyarzun-Ampuero, Felipe
    Department of Pharmaceutical Sciences and Technology, University of Chile.
    Lavandero, Sergio
    Department of Biochemistry & Molecular Biology, University of Chile.
    Kogan, Marcelo J
    Department of Pharmacological and Toxicological Chemistry, University of Chile.
    Novel Nanostructured Polymeric Carriers to Enable Drug Delivery for Cardiovascular Diseases2015In: Current pharmaceutical design, ISSN 1381-6128, E-ISSN 1873-4286, Vol. 21, no 29, p. 4276-4284Article in journal (Refereed)
    Abstract [en]

    Applications of polymeric nanotechnologies for enabling therapies for cardiovascular diseases have shown recent success. Both intravenous and oral administration have been investigated and achieved different degrees of development. While circulating polymeric nanostructured carriers are subjected to a number of interactions, smart nanoparticle design has enabled the formulation of active molecules to be delivered to specific targets for cardiovascular effects. This review aims at outlining the multiple factors that can affect the fate of polymeric nanostructured carriers in systemic circulation. With an understanding of these factors, the literature on the various polymeric nanostructured carriers is reviewed. Finally, the emerging uses of nanotechnology to formulate orally administered drugs for cardiovascular diseases are depicted.

  • 9.
    Morales, Javier O.
    et al.
    College of Pharmacy, University of Texas at Austin.
    Su, Rong
    Department of Pharmacy and Pharmacology, University of Bath.
    McConville, Jason T
    College of Pharmacy, University of Texas at Austin.
    The influence of recrystallized caffeine on water-swellable polymethacrylate mucoadhesive buccal films2013In: AAPS PharmSciTech, ISSN 1530-9932, E-ISSN 1530-9932, Vol. 14, no 2, p. 475-484Article in journal (Refereed)
    Abstract [en]

    The aim of this work was to investigate the influence of particles on the properties of polymethacrylate films intended for buccal delivery. A solvent casting method was used with Eudragit RS and RL (ERS and ERL, respectively) as film-forming rate-controlling polymers, with caffeine as a water-soluble model drug. The physicochemical properties of the model films for a series of formulations with increasing concentrations of caffeine were determined in terms of morphology, mechanical and mucoadhesive properties, drug content uniformity, and drug release and associated kinetics. Typically regarded as non-mucoadhesive polymers, ERS and mainly ERL, were found to be good mucoadhesives, with ERL01 exhibiting a work of mucoadhesion (WoA) of 118.9 μJ, which was about five to six times higher than that observed for commonly used mucoadhesives such as Carbopol(®) 974P (C974P, 23.9 μJ) and polycarbophil (PCP, 17.4 μJ). The mucoadhesive force for ERL01 was found to be significantly lower yet comparable to C974P and PCP films (211.1 vs. 329.7 and 301.1 mN, respectively). Inspection of cross-sections of the films indicated that increasing the concentration of caffeine was correlated with the appearance of recrystallized agglomerates. In conclusion, caffeine agglomerates had detrimental effects in terms of mucoadhesion, mechanical properties, uniformity, and drug release at large particle sizes. ERL series of films exhibited very rapid release of caffeine while ERS series showed controlled release. Analysis of release profiles revealed that kinetics changed from a diffusion controlled to a first-order release mechanism.

  • 10.
    Morales, Javier O.
    et al.
    Department of Sciences and Pharmaceutical Technologies, University of Chile, Santos-Dumont, Santiago.
    Valdés, Karina
    Department of Sciences and Pharmaceutical Technologies, University of Chile, Santos-Dumont, Santiago.
    Morales, Javier
    Department of Sciences and Pharmaceutical Technologies, University of Chile, Santos-Dumont, Santiago.
    Oyarzun-Ampuero, Felipe
    Department of Sciences and Pharmaceutical Technologies, University of Chile, Santos-Dumont, Santiago.
    Lipid nanoparticles for the topical delivery of retinoids and derivatives2015In: Nanomedicine, ISSN 1743-5889, E-ISSN 1748-6963, Vol. 10, no 2, p. 253-269Article in journal (Refereed)
    Abstract [en]

    Retinoids are lipophilic compounds that are highly used in cosmetics/therapeutics for skin disorders. Conventional formulations are limited by poor water solubility, high chemical/photochemical instability and the irritation of retinoids. Interestingly, lipid nanoparticles enable the administration of retinoids in aqueous media, providing drug stabilization and controlled release. Recently, it has been demonstrated that retinoids in solid lipid nanoparticles, nanostructured lipid carriers, nanoemulsions and nanocapsules can decrease degradation, improve targeting and enhance efficacy for the treatment of skin disorders. This article focuses on the formulation, fabrication, characterization and in vitro/in vivo evaluation of solid lipid nanoparticles, nanostructured lipid carriers, nanoemulsions and nanocapsules loaded with retinoids for skin administration. Furthermore, the incorporation of these lipid nanoparticles into secondary vehicles is discussed.

  • 11.
    Oyarzun-Ampuero, Felipe
    et al.
    Departamento de Ciencias y Tecnología Farmacéuticas, Universidad de Chile, Santiago.
    Guerrero, Ariel
    Advancer Center for Chronic Diseases (ACCDiS), Santiago.
    Hassan-Lopez, Natalia
    Advancer Center for Chronic Diseases (ACCDiS), Santiago.
    Morales, Javier O.
    Luleå University of Technology, Department of Health Sciences, Medical Science. Departamento de Ciencias y Tecnología Farmacéuticas, Universidad de Chile, Santiago.
    Bollo, Soledad
    Advancer Center for Chronic Diseases (ACCDiS), Santiago.
    Corvalan, Alejandro
    Advancer Center for Chronic Diseases (ACCDiS), Santiago.
    Quest, Andrew F G
    Advancer Center for Chronic Diseases (ACCDiS), Santiago.
    Kogan, Marcelo J
    Departamento de Ciencias y Tecnología Farmacéuticas, Universidad de Chile, Santiago.
    Organic and Inorganic Nanoparticles for Prevention and Diagnosis of Gastric Cancer2015In: Current pharmaceutical design, ISSN 1381-6128, E-ISSN 1873-4286, Vol. 21, no 29, p. 4145-4154Article in journal (Refereed)
    Abstract [en]

    Organic and inorganic nanoparticles show great potential for cancer diagnosis and treatment. Because gastric cancer (GC) represents the second most deadly type of neoplasia worldwide, continued research efforts by scientists and clinicians are essential to improve diagnosis and treatment. This paper reviews significant findings in the area of nanoparticles (organic and inorganic origin) that may aid in prevention and diagnosis of GC. This review focuses in the first section on H. pylori and the connection to GC, highlighting nanoformulations designed to control bacterial growth. The second section evaluates the potential of different imaging techniques (especially using inorganic nanoparticles) in the detection of GC, and the third section summarizes how nanotechnology may be employed in the analytical detection of GC biomarkers (metallic plasmons, electrochemical biosensors and colorimetric sensors). We foresee that the prevention and diagnosis of GC will require the development of complex collaborative studies. Additionally, scientists also need to be tightly connected to industry in order to facilitate upscaling and rapid transfer of promising products to the clinic.

  • 12.
    Oyarzun-Ampuero, Felipe
    et al.
    Departamento de Ciencias y Tecnología Farmacéuticas, Universidad de Chile, Santiago.
    Vidal, Alejandra
    Instituto de Anatomía Histología y Patología, Universidad Austral de Chile, Valdivia.
    Concha, Miguel
    Instituto de Anatomía Histología y Patología, Universidad Austral de Chile, Valdivia.
    Morales, Javier O.
    Luleå University of Technology, Department of Health Sciences, Health and Rehab. Departamento de Ciencias y Tecnología Farmacéuticas, Universidad de Chile, Santiago, Chile.
    Orellana, Sandra
    Instituto de Ciencias Químicas, Universidad Austral de Chile, Isla Teja, Casilla,Valdivia.
    Moreno-Villoslada, Ignacio
    Instituto de Ciencias Químicas, Universidad Austral de Chile, Isla Teja, Casilla,Valdivia.
    Nanoparticles for the Treatment of Wounds2015In: Current pharmaceutical design, ISSN 1381-6128, E-ISSN 1873-4286, Vol. 21, no 29, p. 4329-4341Article in journal (Refereed)
    Abstract [en]

    The treatment of skin wounds represents an important research area due to the important physiological and aesthetic role of this tissue. During the last years, nanoparticles have emerged as important platforms to treat skin wounds. Silver, gold, and copper nanoparticles, as well as titanium and zinc oxide nanoparticles, have shown potential therapeutic effects on wound healing. Due to their specific characteristics, nanoparticles such as nanocapsules, polymersomes, solid lipid nanoparticles, and polymeric nanocomplexes are ideal vehicles to improve the effect of drugs (antibiotics, growth factors, etc.) aimed at wound healing. On the other hand, if active excipients are added during the formulation, such as hyaluronate or chitosan, the nanomedicine could significantly improve its potential. In addition, the inclusion of nanoparticles in different pharmaceutical materials may enhance the beneficial effects of the formulations, and allow achieving a better dose control. This paper aims at reviewing significant findings in the area of nanoparticles and wound treatment. Among the reviewed topics, we underline formulations comprising inorganic, polymeric, surfactant self-assembled, and lipid nanosystems. Among the drugs included in the nanoformulations, the paper refers to antibiotics, natural extracts, proteins, and growth factors, among others. Finally, the paper also addresses nanoparticles embedded in secondary vehicles (fibers, dressings, hydrogels, etc.) that could improve their application and/or upgrade the release profile of the active.

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