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Pharmaceutical Development and Technology

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https://www.readbyqxmd.com/read/28592183/vaginal-film-for-prevention-of-hiv-using-visual-and-tactile-evaluations-among-potential-users-to-inform-product-design
#1
K M Guthrie, L Rohan, R K Rosen, S E Vargas, J G Shaw, D Katz, E M Kojic, A S Ham, D Friend, K W Buckheit, R W Buckheit
Topical prevention of HIV and other STIs is a global health priority. To provide options for users, developers have worked to design safe, effective and acceptable vaginal dissolving film formulations. We aimed to characterize user experiences of vaginal film size, texture and color, and their role in product-elicited sensory perceptions (i.e. perceptibility), acceptability and willingness to use. In the context of a user-centered product evaluation study, we elicited users' 'first impressions' of various vaginal film formulation designs via visual and tactile prototype inspection during a qualitative user evaluation interview...
June 21, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28590824/continuous-powder-feeding-for-pharmaceutical-solid-dosage-form-manufacture-a-short-review
#2
Caroline A Blackshields, Abina M Crean
There has been a noticeable shift from pharmaceutical batch processing towards a more continuous mode of manufacture for solid oral dosage forms. Continuous solid oral dose processes would not be possible in the absence of a highly accurate feeding system. The performance of feeders defines the content of formulations and is therefore a critical operation in continuous manufacturing of solid dosage forms. It was the purpose of this review to review the role of the initial powder feeding step in a continuous manufacturing process...
June 21, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28565943/an-analytical-gc-ms-method-to-quantify-methyl-dihydrojasmonate-in-biocompatible-oil-in-water-microemulsions-physicochemical-characterization-and-in-vitro-release-studies
#3
Gisela Bevilacqua Rolfsen Ferreira da Silva, Alberto Camilo Alécio, Maria Virginia Costa Scarpa, Eryvaldo Socrates Tabosa do Egito, Rodrigo Sequinel, Rafael Rodrigues Hatanaka, José Eduardo Oliveira, Anselmo Gomes de Oliveira
Microemulsions (MEs) loaded with methyl dihydrojasmonate (MJ) were developed to improve the aqueous solubility of this drug. The composition of the formulations ranged according to the oil/surfactant ratio (O/S). The MEs were characterized according to diameter of droplets, X-ray diffraction and polarized light microscopy. The MJ identification and quantification was performed by gas chromatography-mass spectrometry (GC-MS). The MJ showed a retention time of ∼16.7 min for all samples. The obtained correlation coefficient from the calibration graph was 0...
June 21, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28565928/iron-oxide-magnetic-nanoparticles-as-antimicrobials-for-therapeutics
#4
Lucas de Alcântara Sica de Toledo, Hélen Cássia Rosseto, Marcos Luciano Bruschi
The use of iron oxide magnetic nanoparticles (IMNP) in medical and pharmaceutical areas dates to the beginning of the 1970s, as carriers. Some other uses to these nanoparticles are in vitro separation, magnetic resonance imaging and drug targeting agent. Many preparations containing IMNP have been described and used in drug delivery, hyperthermia, in vitro separation, tissue repair, cellular therapy, for magnetic separation, magnetic resonance imaging, as spoilers for magnetic resonance spectroscopy, and more recently as sensors for metabolites and other biomolecules...
June 21, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28631521/on-the-die-compaction-of-powders-used-in-pharmaceutics
#5
G Aryanpour, M Farzaneh
Die compaction is widely used in the compaction of pharmaceutical powders (tableting). It is well known that the powder densification is a result of particle rearrangement and particle deformation. The former is considered to be the governing mechanism of densification in an initial stage of compaction and the latter is regarded as the governing mechanism in the compaction at the higher pressure range. As a more realistic assumption, one can consider that a simultaneous performance of both the rearrangement and deformation mechanisms takes place from the beginning of compaction...
June 20, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28627282/gallic-acid-pamam-and-gallic-acid-phspholipid-conjugates-physicochemical-characterization-and-in-vivo-evaluation
#6
Ebtsam M Abdou, Marwa A Masoud
Gallic acid (GA) is a naturally occurring compound with valuable antioxidant activity. Its oral bioavailability is limited by its high metabolism and rapid clearance. In this paper, gallic acid (GA) was conjugated with two different materials, phosphatidylcholine (PC) and Polyamidoamine (PAMAM) dendrimer. The prepared conjugates were characterized by FTIR, DSC and SEM. Also, they were tested for drug content and in-vitro drug release. It was found that GA conjugation with both materials have significantly prolonged its release up to 12 hours...
June 19, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28627267/%C3%AE-cyclodextrin-based-ternary-complexes-of-haloperidol-and-organic-acids-the-effect-of-organic-acids-on-the-drug-solubility-enhancement
#7
Prisada Rakkaew, Jiraphong Suksiriworapong, Doungdaw Chantasart
Haloperidol (HALO) is a weak base with very low aqueous solubility that is used as an antipsychotic drug. This study aimed to improve its solubility by forming HALO/β-cyclodextrin (β-CD) based ternary complexes with organic acids. The solubility of HALO/β-CD binary and HALO/β-CD/organic acid ternary complexes in different media (i.e., citrate buffer pH 3 and 6) was explored. The stoichiometric ratio between the drug and β-CD was 1:1 in all complexes formed. The solubility of HALO/β-CD binary complexes significantly increased in citrate buffer pH 3 compared to citrate buffer pH 6...
June 19, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28612675/formulation-of-novel-dry-powder-inhalation-for-fluticasone-propionate-and-salmeterol-xinafoate-with-capsule-based-device
#8
Kyeong Soo Kim, Jeong Hyun Kim, Sung Giu Jin, Dong Wuk Kim, Jong Oh Kim, Chul Soon Yong, Yu Seok Youn, Kyung Taek Oh, Jong Soo Woo, Han-Gon Choi
The aim of this study was to develop a novel fluticasone propionate (FP) and salmeterol xinafoate (SX)-loaded dry powder inhaler (DPI) system, which was composed of powder formulation and performance. The air flow resistances were determined with various types of DPI device, showing that the modified RS01 device gave the specific resistance similar to the commercial DPI device. The particle properties of fluticasone propionate (FP), salmeterol xinafoate (SX) and inhalation grade lactose particles, such as particle size, size distribution and fine content, were assessed...
June 14, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28612663/development-of-multiple-unit-pellet-system-tablets-by-employing-the-sedem-expert-diagram-system-i-pellets-with-different-sizes
#9
Hannlie Hamman, Josias Hamman, Anita Wessels, Jacques Scholtz, Jan Steenekamp
Multiple-unit pellet systems (MUPS) provide several pharmacokinetic and pharmacodynamic advantages over single-unit dosage forms, however, compression of pellets into MUPS tablets present certain challenges. Although the SeDeM Expert Diagram System (SeDeM EDS) was originally developed to provide information about the most appropriate excipient and the minimum amount thereof that is required for producing direct compressible tablets, this study investigated the possibility to apply the SeDeM EDS in the production of MUPS tablets...
June 14, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28608760/plga-peg-ra-based-polymeric-micelles-for-tumor-targeted-delivery-of-irinotecan
#10
Jaber Emami, Parnian Maghzi, Farshid Hasanzadeh, Hojjat Sadeghi, Mina Mirian, Mahboubeh Rostami
To develop an effective therapeutic treatment, the potential of poly (lactic-co-glycolic acid)-polyethylene glycol-retinoic acid (PLGA-PEG-RA) polymeric micelles for targeted delivery of irinotecan to hepatocellular carcinoma (HepG2) and colorectal cancer cell lines (HT-29) was evaluated. PLGA-PEG-RA was synthesized by amide reaction of PLGA with NH2-PEG-NH2 and then PLGA-PEG-NH2 with RA and confirmed by FTIR and (1)H NMR spectroscopy. Irinotecan-loaded nanomicelles were prepared using thin-film hydration method and the impact of various formulation variables on their particle size (PS), polydispersity index (PDI), zeta potential (ZP), entrapment efficiency (EE), and mean release time (MRT) were assessed using a Taguchi design...
June 13, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28604151/stability-and-bioavailability-of-diltiazem-polyethylene-oxide-matrix-tablets
#11
Laila H Emara, Ahmed A El-Ashmawy, Nesrin F Taha
The aim of this study was to prepare and evaluate in-vitro and in-vivo; Diltiazem-Hydrochloride (DTZ) in sustained-release matrix tablets. Stability of DTZ tablets prepared with polyethylene oxide (MWs 900,000, 4000,000 and 8000,000) with or without addition of electrolytes was carried-out for one-month, under short-term storage at 40° C/75% RH. Stability was evaluated by DTZ content, DSC and drug release using the Flow-Through Cell (USP # IV). The majority of stored tablets were stable for one-month under short-term storage with respect to DTZ content and drug release...
June 12, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28598234/design-and-evaluation-of-novel-topical-formulation-with-olive-oil-as-natural-functional-active
#12
Ana Henriques Mota, Catarina Oliveira Silva, Marisa Nicolai, André Baby, Lídia Palma, Patrícia Rijo, Lia Ascensão, Catarina Pinto Reis
Currently, the innovative skin research is focused on the development of novel topical formulations loaded with natural functional actives. The health benefits of olive oil are unsurpassed and many others are revealed as research studies allow the understanding of its unlimited properties. Olive oil has a protective toning effect on skin, but it is not transported effectively into its layers. Aiming the development of a cosmetic formulation for skin photoprotection and hydration, we have prepared and characterized macro-sized particles, made of a hydrogel polymer, loaded with olive oil...
June 9, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28524719/polyester-based-microdisc-systems-for-sustained-release-of-neuroprotective-phosphine-borane-complexes
#13
David A Janus, Christopher J Lieven, Megan E Crowe, Leonard A Levin
Phosphine-borane complexes are recently developed redox-active drugs that are neuroprotective in models of optic nerve injury and radioprotective in endothelial cells. However, a single dose of these compounds is short-lived, necessitating the development of sustained-release formulations of these novel molecules. We screened a library of biodegradable co- and non-block polyester polymer systems for release of incorporated phosphine-borane complexes to evaluate them as drug delivery systems for use in chronic disease...
June 9, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28535123/topical-otic-drugs-in-a-multi-purpose-manufacturing-facility-a-guide-on-determination-and-application-of-permitted-daily-exposure-pde
#14
Lisa Wiesner, Maarten Prause, Ester Lovsin Barle
Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily exposure (PDE) for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. European Medicines Agency (EMA) guidance on setting PDE limits so far focused on systemic administration routes such as intravenous (IV), oral or inhalation. This article provides guidance on setting PDE values for risk management purposes in multi-purpose facilities for active pharmaceutical ingredients (APIs) applied as topical otic drugs to the outer ear canal...
June 7, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28535094/rheological-and-physical-parameters-correlations-in-formulations-with-pinh%C3%A3-o-derivatives-stability-study-building-up-an-analytical-route
#15
Renata Moschini Daudt, Nilo Sergio Medeiros Cardozo, Ligia Damasceno Ferreira Marczak, Irene Clemes Külkamp Guerreiro
This study focuses on the correlation investigation between rheological and physical parameters and how it can contribute to optimize the topical formulations development. A gel and an emulgel containing pinhão derivatives, and their respective controls, were analyzed along six months of storage. A flowchart of analyses was proposed to use in topical formulation development when a benchmark is the goal or when it is necessary to change some raw material. All formulations were stable over the storage time and the formulations containing pinhão starch and coat extract presented similar properties to those of the control formulations...
June 7, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28521578/improved-photostability-and-cytotoxic-effect-of-coenzyme-q10-by-its-association-with-vitamin-e-acetate-in-polymeric-nanocapsules
#16
Natháli S Pegoraro, Juliane Mattiazzi, Elita F da Silveira, Juliana H Azambuja, Elizandra Braganhol, Letícia Cruz
The present study showed the development of nanocapsules containing the association of the coenzyme Q10 and vitamin E acetate and the evaluation of their effect on in vitro cells culture of malignant glioma and melanoma. In order to investigate if nanocapsules are able to protect coenzyme Q10 from degradation under UVC radiation, a photostability study was carried out. For this, three concentrations of vitamin E acetate were evaluated (1%, 2%, or 3%). Nanocapsules presented suitable physicochemical characteristics and were able to protect coenzyme Q10 from photodegradation...
June 7, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28565934/aceclofenac-oil-drops-characterization-and-evaluation-against-ocular-inflammation
#17
Rajesh Katara, Sameer Sachdeva, Dipak K Majumdar
Ocular inflammatory diseases, such as uveitis, scleritis, episcleritis, and dry eye syndrome are commonly treated with eye drop formulations. In the present study, attempts were made to prepare aceclofenac oil formulations to evaluate its transcorneal permeation and anti-inflammatory effect. Ophthalmic solutions of aceclofenac with or without (0.5% v/v) benzyl alcohol were formulated in different vegetable oils and permeation studies were carried out. Aceclofenac ophthalmic solution in linseed oil containing benzyl alcohol exhibited maximum permeation (4...
June 1, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28488447/increasing-efficacy-and-reducing-systemic-absorption-of-brimonidine-tartrate-ophthalmic-gels-in-rabbits
#18
Xiaochen Pang, Jiawei Li, Jiaxin Pi, Dongli Qi, Pan Guo, Nan Li, Yumei Wu, Zhidong Liu
Systemic absorption of ocularly administered Brimonidine Tartrate has been reported to give rise to several side-effects. Hence, it has become crucial to develop a delivery system that could increase efficacy and reduce systemic absorption. Therefore, the present work aims to develop Brimonidine Tartrate gels with different concentrations (0.05%, 0.1%, and 0.2% w/v, respectively) using Carbopol 974 P and HPMC E4M, and compare the therapeutic efficacy and systemic absorption with that of eye drop (0.2%, w/v) by UPLC-MS/MS...
May 31, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28540754/zero-order-release-and-bioavailability-enhancement-of-poorly-water-soluble-vinpocetine-from-self-nanoemulsifying-osmotic-pump-tablet
#19
Sally A El-Zahaby, Mohamed H H AbouGhaly, Ghada A Abdelbary, Omaima N El-Gazayerly
Solid self-nanoemulsifying (S-SNEDDS) asymmetrically coated osmotic tablets of the poorly water-soluble drug Vinpocetine (VNP) were designed. The aim was to control the release of VNP by the osmotic technology taking advantage of the solubility and bioavailability-enhancing capacity of S-SNEDDS. Liquid SNEDDS loaded with 2.5 mg VNP composed of Maisine™ 35-1, Transcutol® HP and Cremophor(®) EL was adsorbed on the solid carrier Aeroperl(®). S-SNEDDS was mixed with the osmotic tablet excipients (Sodium chloride, Avicel(®), HPMC-K4M, PVP-K30 and Lubripharm(®)), then directly compressed to form the core tablet...
May 25, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28535125/preparation-and-characterization-of-adefovir-dipivoxil-stearic-acid-cocrystal-with-enhanced-physicochemical-properties
#20
Jeong-Woong Seo, Kyu-Min Hwang, Sung-Hoon Lee, Dong-Wook Kim, Eun-Seok Park
The objectives of this study were to prepare cocrystal composed of adefovir dipivoxil (AD) and stearic acid (SA) and to investigate the enhanced properties of the cocrystal. The cocrystal was prepared by antisolvent precipitation and characterized by scanning electron microscopy (SEM), Fourier transform infrared spectroscopy (FT-IR), X-ray powder diffraction (XRPD), and differential scanning calorimetry (DSC). The enhanced properties were evaluated by dissolution testing, permeability studies, and powder rheology analysis...
May 23, 2017: Pharmaceutical Development and Technology
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