Author: Klee, David M ; Hammersmith, Gregory ; Rapp, Kersten ; Myerson, Allan S ; Azad, Mohammad A ; Capellades, Gerard ; Brancazio, David ; Wang, Allison B

AbstractThe U.S. Food and Drug Administration (FDA) emphasizes drug product development by Quality by Design (QbD). Critical material attributes (CMAs) are a QbD element that has an impact on pharmaceutical operations and product quality. Pharmaceutical drugs often crystallize as needle-shaped (a CMA) particles and affect the process due to poor flowability, low bulk density, and high compressibility, and eventually the product performance. In this study, the product obtained from crystallization was needle-shaped Ciprofloxacin HCl (CIPRO), formed lumps during drying, and compacted during processing through feeders. To delump small amounts of materials and break the needles, multiple available devices (mortar-pestle, Krups grinder) and custom-made grinder were assessed before formulation. The processed CIPRO powder was then used to make tablets in the miniature tablet manufacturing unit developed by the team at MIT. The critical quality attributes (CQA) of the tablets, set by the United States Pharmacopeia (USP), were then assessed for the drug powder processed with each of these devices. Powder properties comparable to commercial CIPRO were obtained when the custom MIT-designed grinder was used, leading to tablets that meet the USP criteria, with comparable dissolution profiles of those for marketed CIPRO tablets. This study demonstrates how needle-shaped crystals have an impact on pharmaceutical operations, even if it is on a miniature scale, and how proper shape and subsequent flow properties can be obtained by processing the particles through the MIT team-designed grinder.Graphical Abstract

01 Aug 2017·The LaryngoscopeQ1 · MEDICINE

Price variation in the most commonly prescribed ear drops in Southern California

Q1 · MEDICINE

Article

Author: Ghavami, Yaser ; Moshtaghi, Omid ; Gu, Jeff ; Lin, Harrison W. ; Huang, Melissa ; Djalilian, Hamid R. ; Moshtaghi, Afsheen ; Haidar, Yarah M. ; Sahyouni, Ronald

Objectives/HypothesisTo evaluate the variability and discrepancies among the most commonly prescribed ear drops sold at pharmacies in southern California.Study DesignProspective study evaluating 11 commonly used ear drops to treat otologic disorders.MethodsRandomly selected drug stores in three major counties in Southern California (Los Angeles, Orange, and San Diego) were included. Mean, range, minimum, and maximum prices for each drug were calculated and analyzed. The median income of pharmacy ZIP code was also cross‐referenced.ResultsData were collected from 108 pharmacies. The mean prices are noted for each of the individual drugs: Cortisporin (brand) 10 mL, $82.70; neomycin, polymyxin B sulfates, and hydrocortisone (Cortisporin–generic) 10 mL, $34.70; ofloxacin (generic) 10 mL, $99.95; sulfacetamide (generic) 15 mL, $40.18; Ciprodex (brand) 7.5 mL, $194.44; Cipro HC (brand) 10 mL, $233.32; Vosol (brand) 15 mL, $120.75; acetic acid (Vosol–generic) 10 mL, $116.55; VosolHC (brand) 10 mL, $204.14; acetic acid/aluminum acetate (Domeboro–generic) 60 mL, $22.91; and Tobradex (brand) 5 mL, $166.47.ConclusionsThere is significant variability among the prices of ear drops across Southern Californian pharmacies, which can be a financial burden to patients paying out of pocket or with high deductibles. A state‐mandated, publically accessible report of drug prices may help decrease variability and cost by promoting competition among pharmacies. Price negotiations by governmental payers may assist in reducing prices. In the treatment of otologic disorders, clinicians can help reduce costs for patients by prescribing generic ear drop medications and cheaper alternatives when clinically appropriate.Level of Evidence4. Laryngoscope, 127:1780–1784, 2017

01 Jan 2014·International Journal of Pharmaceutical Investigation

Thermosensitive periodontal sol of ciprofloxacin hydrochloride and serratiopeptidase: Pharmaceutical and mechanical analysis

Article

Author: Pathak, Kamla ; Chhabra, Gulshan ; Sharma, Vijay ; Singh, Kushal Pal

AIMThe aim of the present work was to explore the development of a dual-controlled release periodontal system of a potent broad spectrum first-generation fluoroquinolone, ciprofloxacin, and the anti-inflammatory enzyme serratiopeptidase (STP).MATERIALS AND METHODSBased on 3(2) full factorial design, thermoreversible periodontal sols capable of controlled dual delivery of ciprofloxacin hydrochloride and STP were designed using pluronic F127 and carbopol 934P as thermosensitive gelling polymers. Sol gel transition characteristics, %cumulative drug release at 48(th) h and exvivo mucoadhesive strength were designated as dependent responses. The sols were mucoadhesive, syringeable, and inverted into gels at simulated periodontal cavity temperature.RESULTSF9 with optimal drug release was identified as the best formulation. Extra design check point generated using Design Expert software 8.02 (Stat-Ease, USA) validated the experimental design. Textural analysis revealed that the developed sols were syringeable and spreadable enough for periodontal treatment so it can be expected that hardness and compressibility of sols would pose no problem during clinical application. The in vitro release behavior exhibited controlled release of both cipro HCl and STP (>90% release).CONCLUSIONA dual-controlled release thermoreversible periodontal sol of ciproflaxin and STP was successfully developed. Incorporation of STP as anti-inflammatory agent has the potential of developing a therapeutically efficacious system of cipro HCl for treatment of periodontal inflammatory anaerobic infections.

100 Deals associated with Ciprofloxacin Hydrochloride/Hydrocortisone

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KEGG	Wiki	ATC	Drug Bank
-	-	S02CA03 S03CA04 S01CA03	-

R&D Status

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Indication	Country/Location	Organization	Date
Bone and joint infections	US	Sandoz, Inc.	10 Feb 1998
Lower Respiratory Tract Infections	US	Sandoz, Inc.	10 Feb 1998
Urinary Tract Infections	US	Sandoz, Inc.	10 Feb 1998

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