Developing an injectable formula containing an oxygen-sensitive drug: a case study of danofloxacin injectable.

Abstract:

:The purpose of this study was to assess the impact of impurities in formulation components, antioxidants, formulation pH, and processing/packaging on the extent of color change associated with oxidation of danofloxacin injectable. The methods used in this study include reversed-phase HPLC, UV-VIS spectrophotometry, atomic absorption spectroscopy, visual observation, and iodimetric titration for quantification of the antioxidant. The results from this study revealed that trace impurities from two different excipients significantly contributed to color change associated with oxidation. Polyvinyl pyrrolidone (PVP) introduced trace levels of peroxides into the solution. A second excipient also had a significant impact on stability because it introduced trace metal impurities into the product. The minimization of oxygen levels alone in the solution and headspace was not sufficient to completely eliminate the product instability. The addition of an antioxidant, monothioglycerol (MTG), resulted in a formulation less sensitive to processing variables. The impact of pH on the performance of MTG was also studied. At pH 7.5, MTG resulted in significant improvement in stability; however, at pH 6.0 it was not effective as an antioxidant. Process modifications alone may not be sufficient to prevent oxidation. Chemical approaches, such as pH control, addition of an antioxidant, and control of components should be considered first as means of enhancing stability of oxygen-sensitive solutions.

journal_name

Pharm Dev Technol

authors

Kasraian K,Kuzniar AA,Wilson GG,Wood JA

doi

10.1081/pdt-100101384

subject

Has Abstract

pub_date

1999-01-01 00:00:00

pages

475-80

issue

4

eissn

1083-7450

issn

1097-9867

journal_volume

4

pub_type

杂志文章
  • Synthesis, characterization, and kinetic release study of methotrexate loaded mPEG-PCL polymersomes for inhibition of MCF-7 breast cancer cell line.

    abstract::In this study, we designed a polymersome system for the controlled release of methotrexate (MTX) as an anticancer drug with the objective of improving the loading efficiency of the drug in polymersomes as well as achievement of an efficient control on the release rate of drug from nanocarriers. We synthesized mono met...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2018.1425433

    authors: Nosrati H,Adinehvand R,Manjili HK,Rostamizadeh K,Danafar H

    更新日期:2019-01-01 00:00:00

  • Plasma stable, pH-sensitive non-ionic surfactant vesicles simultaneously enhance antiproliferative effect and selectivity of Sirolimus.

    abstract:OBJECTIVE:The purpose of the present investigation was to prepare a plasma stable, pH-sensitive niosomal formulation to enhance Sirolimus efficacy and selectivity. MATERIALS AND METHODS:pH-sensitive niosomal formulations bearing PEG-Poly (monomethyl itaconate)-CholC6 (PEG-PMMI-CholC6) copolymers and cholesteryl hemisu...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2013.860553

    authors: Ghanbarzadeh S,Khorrami A,Pourmoazzen Z,Arami S

    更新日期:2015-05-01 00:00:00

  • Influence of the type of vegetable oil on the drug release profile from lipid-core nanocapsules and in vivo genotoxicity study.

    abstract::The use of rice bran (RB), soybean (SB) or sunflower seed (SF) oils to prepare lipid-core nanocapsules (LNCs) as controlled drug delivery systems was investigated. LNCs were prepared by interfacial deposition using the preformed polymer method. All formulations showed negative zeta potential and adequate nanotechnolog...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2013.829097

    authors: Rigo LA,Frescura V,Fiel L,Coradini K,Ourique AF,Emanuelli T,Quatrin A,Tedesco S,Silva CB,Guterres SS,Pohlmann AR,Beck RC

    更新日期:2014-11-01 00:00:00

  • Tablets prepared by single-step granulation/tabletting: interparticulate binding mechanism and stability.

    abstract::The binding mechanism of tablets prepared by single-step granulation/tabletting (SSGT), a novel technique for the production of tablets, was evaluated. SSGT yielded hard tablets having a short disintegration time due to their porous, spongelike internal structure. Calculation of the interaction factor and electrical c...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-65690

    authors: Vermeire A,Keleb EI,Kiekens F,Van Driessche I,Hoste S,Remon JP,Vervaet C

    更新日期:2005-01-01 00:00:00

  • Photoinduced particulate matter in a parenteral formulation for bisnafide, an experimental antitumor agent.

    abstract::This paper assesses the cause of particulate formation in vials of the experimental antitumor agent bisnafide and investigates pharmaceutical techniques to reduce the number of particulates in the product. Solution preparation and particulate isolation were performed under Class 100 laminar air flow. Reversed-phase HP...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-100101380

    authors: Rubino JT,Chan LL,Walker JT,Segretario J,Everlof JG,Hussain MA

    更新日期:1999-08-01 00:00:00

  • In vitro/in vivo correlation and modeling of emitted dose and lung deposition of inhaled salbutamol from metered dose inhalers with different types of spacers in noninvasively ventilated patients.

    abstract::Substituting spacer by another in noninvasive ventilation (NIV) involves many variables, e.g. total emitted dose (TED), mass median aerodynamic diameter (MMAD), type of spacer, total lung deposition and total systemic absorption, which must be adjusted to ensure patient optimum therapy. Data mining based on artificial...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2015.1116567

    authors: Hussein RRS,M A Ali A,Salem HF,Abdelrahman MM,Said ASA,Abdelrahim MEA

    更新日期:2017-11-01 00:00:00

  • Novel organogels for topical delivery of naproxen: design, physicochemical characteristics and in vitro drug permeation.

    abstract::Taking into account possible irritation of the skin upon contact with naproxen (NPX) crystals and lower bioavailability after administration of the suspended or ionized drug, the aim of the work was to design and characterize novel and easy-to-formulate gels with the entirely dissolved drug in the acidic form. The for...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2015.1135342

    authors: Osmałek T,Milanowski B,Froelich A,Górska S,Białas W,Szybowicz M,Kapela M

    更新日期:2017-06-01 00:00:00

  • Chemical delivery systems: evaluation of physicochemical properties and enzymatic stability of phenylephrone derivatives.

    abstract::The physicochemical properties and enzymatic stability of esters of phenylephrone, synthesized on the basis of the chemical delivery system (CDS) concept, were studied as a new class of mydriatic agents. Potentiometrically determined ionization constants (pKa) of the novel compounds were in the range 7.19-7.21. The th...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-100101353

    authors: Goskonda VR,Khan MA,Bodor NS,Reddy IK

    更新日期:1999-05-01 00:00:00

  • Improvement of the material motion in a rotary processor.

    abstract::The purpose of this paper is to reject or to confirm the hypothesis that the influence of the water addition rate on the size and size distribution of pellets is caused by insufficient spreading of the added water at higher water addition rates. To overcome insufficient spreading of the added water, the agitation in t...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837459609031431

    authors: Vertommen J,Jaucot B,Rombaut P,Kinget R

    更新日期:1996-12-01 00:00:00

  • Formulation and processing factors influencing the adhesion of film coats to tablet cores.

    abstract::The effect of six factors: spray gun, formulation, inlet temperature, atomizing air pressure, fan air pressure, and gun-bed distance, on the final adhesion of the film coat to the tablet core were assessed. The method used was based on an experimental design, Resolution IV, that allowed the main effects to be free fro...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-49692

    authors: Khan H,Fell JT,Macleod GS

    更新日期:2005-01-01 00:00:00

  • Poly(glycerol methacrylate)-based degradable nanoparticles for delivery of small interfering RNA.

    abstract::Nucleic acids therapeutic efficiency is generally limited by their low stability and intracellular bioavailability, and by the toxicity of the carriers used to deliver them to the target sites. Aminated poly(glycerol methacrylate) polymers are biodegradable and pH-sensitive polymers that have been used previously to d...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2017.1312443

    authors: Morsi NG,Ali SM,Elsonbaty SS,Afifi AA,Hamad MA,Gao H,Elsabahy M

    更新日期:2018-04-01 00:00:00

  • In vitro release of colchicine using poly(phosphazenes): the development of delivery systems for musculoskeletal use.

    abstract::A colchicine release system utilizing biodegradable poly(phosphazenes) was investigated in vitro for intra-articular administration. Polymer degradation and drug release studies were performed on colchicine-loaded poly(phosphazenes) containing either imidazolyl (I-PPHOS) or ethyl glycinato (EG-PPHOS) side chain substi...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837459809028479

    authors: Ibim SM,el-Amin SF,Goad ME,Ambrosio AM,Allcock HR,Laurencin CT

    更新日期:1998-02-01 00:00:00

  • Silk fibroin nanoparticles for enhanced bio-macromolecule delivery to the retina.

    abstract::The aim of this study was to investigate intravitreal injection of silk fibroin nanoparticles (SFNs) encapsulating bio-macromolecules, achieving enhanced drug bioavailability, and extended retention in retina. SFNs were prepared with regenerated silk fibroin using desolvation method with fluorescein isothiocyanate lab...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2018.1545236

    authors: Yang P,Dong Y,Huang D,Zhu C,Liu H,Pan X,Wu C

    更新日期:2019-06-01 00:00:00

  • Design and evaluation of ocular drug delivery system for controlled delivery of gatifloxacin sesquehydrate: In vitro and in vivo evaluation.

    abstract::The objective of this investigation was to formulate ocular inserts of gatifloxacin sesquehydrate to achieve controlled drug release. Drug reservoir was prepared using hydrophilic polymers, namely polyvinyl alcohol and polyvinyl pyrrolidone. The rate controlling membrane was prepared using hydrophobic ethyl cellulose ...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2010.502178

    authors: Patel UL,Chotai NP,Nagda CD

    更新日期:2012-01-01 00:00:00

  • Novel metrics to compare dissolution profiles.

    abstract:PURPOSE:To evaluate four novel metrics that compare dissolution profiles and assess their performance characteristics by comparing dissolution profiles of FAST and SLOW immediate release metoprolol tartrate tablets. METHODS:The four novel metrics (rho, rho m, delta a, and delta s), along with f2, were applied to disso...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-120003493

    authors: Seo PR,Shah VP,Polli JE

    更新日期:2002-05-01 00:00:00

  • Multiunit controlled-release diclofenac sodium capsules using complex of chitosan with sodium alginate or pectin.

    abstract::This study explored the application of chitosan-alginate (CA) and chitosan-pectin (CP) complex films as drug release regulator for the preparation of multiunit controlled-release diclofenac sodium capsules. Pellets containing drug and microcrystalline cellulose, in a ratio of 3:5, were prepared in a fluidized rotary g...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-100002247

    authors: Mitrevej A,Sinchaipanid N,Rungvejhavuttivittaya Y,Kositchaiyong V

    更新日期:2001-08-01 00:00:00

  • Isotropic systems of medium-chain mono- and diglycerides for solubilization of lipophilic and hydrophilic drugs.

    abstract::The aim of this study was to investigate isotropic mono- and diglyceride-based (MCMDG) systems, which are potential vehicles for injectable products containing both hydrophilic and lipophilic drugs. For two-component systems, MCMDG was mixed with various masses of water. For three-component systems, the samples were p...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-120027422

    authors: Sari P,Razzak M,Tucker IG

    更新日期:2004-01-01 00:00:00

  • Formulation, development, and in-vitro/ex-vivo evaluation of vaginal bioadhesive salbutamol sulfate tablets for preterm labor.

    abstract::Preterm labor is the main cause of death and serious illness of both infants and pregnant women in Africa and worldwide. Parenteral and oral salbutamol sulfate as a B2 antagonist has been used for the treatment of preterm labor. The study aims are to formulate salbutamol sulfate non-invasive vaginal bioadhesive tablet...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2020.1767129

    authors: El-Enin ASMA,Elbakry AM,Hosary RE,Lotfy MAF

    更新日期:2020-10-01 00:00:00

  • Preparation and optimization of glyceryl behenate-based highly porous pellets containing cilostazol.

    abstract::The aim of this study was to prepare a highly porous multiparticulate dosage form containing cilostazol for gastroretentive drug delivery. The floating pellets were prepared with glyceryl behenate as a matrix former and camphor as a sublimating agent by extrusion/spheronization and sublimation under vacuum. Granules p...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2016.1245743

    authors: Hwang KM,Byun W,Cho CH,Park ES

    更新日期:2018-06-01 00:00:00

  • Phase transition of a microemulsion upon addition of cyclodextrin - applications in drug delivery.

    abstract::This study reports on the impact of cyclodextrin addition on the phase behavior of microemulsion systems. Three distinct oil-in-water microemulsions were formulated and subjected to increasing concentrations of various cyclodextrins. The prepared formulations underwent visual, textural and microscopic characterization...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2017.1371191

    authors: Thakur SS,Solloway J,Stikkelman A,Seyfoddin A,Rupenthal ID

    更新日期:2018-02-01 00:00:00

  • Formulation and physicochemical characterization of chitosan/acyclovir co-crystals.

    abstract::In the current study, the influence of chitosan on the dissolution rate and bioavailability of acyclovir has been illustrated through the preparation of co-crystals by simple solvent change method. Chitosan was precipitated on acyclovir crystals using sodium citrate as the salting out agent. The pure drug and the prep...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2011.595798

    authors: Allam AN,Naggar VF,El Gamal SS

    更新日期:2013-07-01 00:00:00

  • About the equivalence between different batches of a glycopeptide drug.

    abstract:CONTEXT:Teicoplanin is a glycopeptide antibiotic consisting of a combination of different active components. Clinical equivalence between different batches of this drug is not guaranteed by the present pharmacopeial specification of chemical composition based on an HPLC chromatogram. OBJECTIVE:To test a modification o...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2015.1035726

    authors: Boix-Montañes A,Garcia-Arieta A

    更新日期:2016-08-01 00:00:00

  • Orally disintegrating tablets and orally disintegrating mini tablets - novel dosage forms for pediatric use.

    abstract::The oral administration route is considered to be the most widely used route because of its convenience of administration and manufacturing. Dosage forms, like orally disintegrating tablets (ODTs), mini tablets, and orally disintegrating mini tablets (ODMTs), are recognized as promising for use in pediatric patients. ...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章,评审

    doi:10.1080/10837450.2019.1615090

    authors: Comoglu T,Dilek Ozyilmaz E

    更新日期:2019-09-01 00:00:00

  • Formulation and evaluation of curcumin gel for topical application.

    abstract::The aim of the present investigation was to develop and study topical gel delivery of curcumin for its anti-inflammatory effects. Carbopol 934P (CRB) and hydroxypropylcellulose (HPC) were used for the preparation of gels. The penetration enhancing effect of menthol (0-12.5% w/w) on the percutaneous flux of curcumin th...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450802409438

    authors: Patel NA,Patel NJ,Patel RP

    更新日期:2009-01-01 00:00:00

  • Studies on preparation of carbamazepine (CBZ) supersaturatable self-microemulsifying (S-SMEDDS) formulation and relative bioavailability in beagle dogs.

    abstract::The main purpose of this work was to develop a supersaturatable self-microemulsifying drug delivery system (S-SMEDDS) of carbamazepine (CBZ). S-SMEDDS of CBZ was prepared and drug precipitation behavior, dissolution rate in vitro and particle size distribution were evaluated. The relative bioavailability of S-SMEDDS f...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837451003774419

    authors: Zhang N,Zhang W,Jin Y,Quan DQ

    更新日期:2011-08-01 00:00:00

  • Formulation development and systematic optimization of stabilized ziprasidone hydrochloride capsules devoid of any food effect.

    abstract:CONTEXT AND OBJECTIVE:The objective of the study was to develop a stable capsule formulation of ziprasidone hydrochloride which can be administered without regards to food intake. MATERIALS AND METHODS:The unstable anhydrous form of ziprasidone hydrochloride was stabilized employing hot-melt extrusion and further opti...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2015.1055764

    authors: Banerjee S,Shankar KR,Prasad Y R

    更新日期:2016-11-01 00:00:00

  • Generation of gelatin aerosol particles from nebulized solutions as model drug carrier systems.

    abstract:PURPOSE:Aerodynamically stable, nebulized aerosols are desirable to achieve optimum asthma therapy. Stabilizing droplet size using gel-forming polymers may assist in achieving this goal. Semisolid particles may be generated through aerosolization of a polymer solution. Gelatin was employed as a model polymer in a proce...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-120003483

    authors: Deaton AT,Jones LD,Dunbar CA,Hickey AJ,Williams DM

    更新日期:2002-05-01 00:00:00

  • The apparent solubilizing capacity of simulated intestinal fluids for poorly water-soluble drugs.

    abstract::Drug solubility testing in biorelevant media has become an indispensable tool in pharmaceutical development. Despite this importance, there is still an incomplete understanding of how poorly soluble compounds interact with these media. The aim of this study was to apply the concept of the apparent solubilization capac...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837451003664099

    authors: Schwebel HJ,van Hoogevest P,Leigh ML,Kuentz M

    更新日期:2011-06-01 00:00:00

  • Doxorubicin-loaded microgels composed of cinnamic acid-gelatin conjugate and cinnamic acid-Pluronic F127 conjugate.

    abstract::Microgels were prepared by cinnamic acid-gelatin (type B) conjugate (CA-GelB) and cinnamic acid-Pluronic F127 conjugate (CA-Plur). (1)H NMR confirmed that CA was conjugated to gelatin and the gelatin to CA residue molar ratio was estimated to be 1:4.7 by a colorimetric method. CA-Plur of which the CA residue to Plur m...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2014.999787

    authors: Zhang H,Kim JC

    更新日期:2016-01-01 00:00:00

  • Isolation technology for research and development applications: from concept to production.

    abstract::A prototype parenteral manufacturing facility based on isolation technology was designed, constructed, and commissioned at Warner-Lambert Co., Morris Plains, NJ, with emphasis on its application to research and development (R&D) settings. The facility contains closed isolators for holding, transferring, and manufactur...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-100102034

    authors: Krishna AK,Lodhi SA,Harris MR

    更新日期:2000-01-01 00:00:00