Bioavailability testing of a newly developed clindamycin oral suspension in a pediatric porcine model.

Abstract:

:Background: Clindamycin's bitter taste and odor is known to affect treatment adherence in children. Recently, a formulation of clindamycin HCl complexed with ion exchange resin IRP 69 was shown to mask the bitter taste. Because of the potential benefit of this formulation for children, a pilot study using a porcine model was conducted to evaluate its relative bioavailability. Methods: A randomized two-way crossover study design using six (n = 6) healthy male piglets 10-12 kg was used to evaluate the absorption profiles and pharmacokinetic parameters of clindamycin from the resinate complex formulation (Test) compared to a commercialized reference suspension. A dose of 15 mg/kg was administered orally by gastric gavage to each piglet followed by repeated blood sampling over 12 h. A wash-out period of 48 h occurred between treatments. Plasma concentration vs. time data was analyzed by non-compartmental analysis. Results: The mean relative bioavailability of clindamycin from the resinate formulation was 78.8%. A two-tailed, paired Student t test yielded a p < 0.05 for AUC∞ and Tmax parameters. A two one-sided test (TOST) suggested a difference in AUC∞ and Cmax for the Test formulation compared to the reference formulation according to the FDA's criteria for bioequivalence. Conclusion: The bioavailability of clindamycin from this novel oral formulation supports continued evaluation of the drug in humans for potential pediatric applications.

journal_name

Pharm Dev Technol

authors

Goode GA,Wagh SJ,Irby DJ,Ma D,Jacobs RF,Kearns GL,Almoazen H

doi

10.1080/10837450.2019.1624771

subject

Has Abstract

pub_date

2019-10-01 00:00:00

pages

1038-1043

issue

8

eissn

1083-7450

issn

1097-9867

journal_volume

24

pub_type

杂志文章,随机对照试验
  • Characterization of acid modified Dioscorea starches as direct compression excipient.

    abstract::Starches obtained from four different Dioscorea species namely White (D. rotundata), Bitter (D. dumetorum), Chinese (D. oppositifolia) and Water yam (D. alata), were modified by acid hydrolysis and the physicochemical, material and tablet formation properties of the starches were investigated with the aim of determini...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450802572367

    authors: Odeku OA,Picker-Freyer KM

    更新日期:2009-01-01 00:00:00

  • Utilizing quantitative certificate of analysis data to assess the amount of excipient lot-to-lot variability sampled during drug product development.

    abstract::Understanding variability in excipient physico-chemical properties is becoming an important aspect of Quality-by-Design drug product development. However, present experimental methods have only been able to study a few physico-chemical properties for a few excipient lots due to time, cost, and sample gathering conside...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2011.604784

    authors: Kushner J 4th

    更新日期:2013-03-01 00:00:00

  • Pharmacokinetics of 16-dehydropregnenolone hydroxypropyl-β-cyclodextrin inclusion complex following peroral administration.

    abstract::16-Dehydropregnenolone (16-DHP) is an active compound with an unsatisfied in vivo behavior and poor water-solubility, which limits its clinical application. To improve its in vivo behavior and water-solubility, a Hydroxypropyl-beta-Cyclodextrin (HP-β-CD) inclusion complex of 16-DHP was prepared in this paper. Pharmaco...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2016.1193192

    authors: Sun Y,Jia L,Zhou H,Mao M,Wang X,Wei L,Sun L

    更新日期:2017-03-01 00:00:00

  • A new method for evaluating the dissolution of orodispersible films.

    abstract::The aim of this research was to develop and assess a new dissolution apparatus for orodispersible films (ODFs). The new apparatus was based on a flow-through cell design which requires only a limited amount of dissolution medium and can automatically collect samples in short-time intervals. Compared with the dissoluti...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2014.882936

    authors: Xia Y,Chen F,Zhang H,Luo C

    更新日期:2015-05-01 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

  • 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

  • Identification of physical-chemical variables affecting particle size following precipitation using a supercritical fluid.

    abstract::The physical-chemical processing variables affecting particle size following precipitation using the supercritical antisolvent (SAS) method were investigated by varying both the composition of the feed solvent and the structure of the solute, using a series of steroids. The key factor influencing particle size in thes...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450600561299

    authors: Sacha GA,Schmitt WJ,Nail SL

    更新日期:2006-01-01 00:00:00

  • The nonsteady state modeling of freeze drying: in-process product temperature and moisture content mapping and pharmaceutical product quality applications.

    abstract:INTRODUCTION:Theoretical models of the freeze-drying process are potentially useful to guide the design of a freeze-drying process as well as to obtain information not readily accessible by direct experimentation, such as moisture distribution and glass transition temperature, Tg, within a vial during processing. Previ...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-35869

    authors: Pikal MJ,Cardon S,Bhugra C,Jameel F,Rambhatla S,Mascarenhas WJ,Akay HU

    更新日期:2005-01-01 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

  • Degradation of a pharmaceutical in HPLC grade methanol containing trace level formaldehyde.

    abstract::An anomalous peak was observed in the HPLC/UV analysis of a developmental drug product. High resolution LC/MS revealed that the mass of this degradant was 12 Da greater than the drug substance, corresponding to a net gain of a single carbon atom. The degradant was reproduced by incubating the drug substance with forma...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2012.696265

    authors: Zhong Q,Stowers S,Segraves NL,Ngim KK,Zhang K,Bostick T,Deese A,Chetwyn NP

    更新日期:2013-07-01 00:00:00

  • Effects of light intensity, n-alcohols, water-soluble colorants, and solution viscosity on photoisomerization of sorivudine.

    abstract::Effects of various factors, such as light intensity, polarizability of n-alcohol solvents, addition of colorants, and viscosity of solutions on the kinetics of the photoisomerization of therapeutically effective E-isomer of sorivudine to its less effective Z-isomer were studied. Solutions of known concentrations of E-...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-100000047

    authors: Desai D,Li D,Janjikhel R,Lang B,Jain N

    更新日期:2001-01-01 00:00:00

  • Preparation of a reproducible long-acting formulation of risperidone-loaded PLGA microspheres using microfluidic method.

    abstract::The aim of the present study is to prepare risperidone-loaded poly lactic-co-glycolic acid (PLGA) microspheres within microfluidic system and to achieve a formulation with uniform size and monotonic and reproducible release profile. In comparison to batch method, T-junction and serpentine chips were utilized and optim...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2016.1221426

    authors: Jafarifar E,Hajialyani M,Akbari M,Rahimi M,Shokoohinia Y,Fattahi A

    更新日期:2017-09-01 00:00:00

  • Purification of pharmaceutical excipients with supercritical fluid extraction.

    abstract::Supercritical fluid extraction (SFE), with carbon dioxide as the solvent, was tested for its ability to remove common reactive impurities from several pharmaceutical excipient powders including starch, microcrystalline cellulose (MCC), hydroxypropylcellulose (HPC), polyethylene oxide (PEO), and polyvinylpyrrolidone (P...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450500299958

    authors: Ashraf-Khorassani M,Taylor LT,Waterman KC,Narayan P,Brannegan DR,Reid GL

    更新日期:2005-01-01 00:00:00

  • Modern pediatric formulations of the soft candies in the form of a jelly: determination of metoclopramide content and dissolution.

    abstract::In pediatrics, it is crucial to ameliorate the unpleasant taste of oral pharmaceutical formulations in order to facilitate patient compliance. Scientists' attempt to develop modern products for children is included among the new trends in pharmaceutical technology. Designing the preparation procedures and selecting th...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2019.1609499

    authors: Karaiskou SG,Kouskoura MG,Markopoulou CK

    更新日期:2020-01-01 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

  • 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

  • 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

  • One-step preparation of ibuprofen fast- and sustained-release formulation by electrospinning with improved efficacy and reduced side effect.

    abstract::In this study, we developed a one-step method to prepare ibuprofen fast- and sustained-release complex preparation. It was based on a double jets electrospinning process. Ibuprofen, a poorly water-soluble drug, was electrospun into fibers with polyvinyl pyrrolidone and hydroxypropyl methyl cellulose by two jets, respe...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2020.1728773

    authors: Che X,Xue J,Zhang J,Yang X,Wang L

    更新日期:2020-07-01 00:00:00

  • Development and evaluation of a laboratory-scale apparatus to simulate the scale-up of a sterile semisolid and effects of manufacturing parameters on product viscosity.

    abstract::The purpose of this study was to develop a benchtop apparatus to simulate the scale-up of the moist-heat sterilization process of sodium carboxymethylcellulose (CMC) gel and identify critical process parameters that affect the sterilized gel viscosity. A 600-ml benchtop Parr reactor was modified and used to achieve go...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1081/pdt-100101394

    authors: Chu PI,Doyle D

    更新日期:1999-01-01 00:00:00

  • Percolation theory and the role of maize starch as a disintegrant for a low water-soluble drug.

    abstract::The objective of the present work is to investigate the presence or absence of a critical concentration of maize starch according to the percolation theory for a truly ternary system with respect to a minimum disintegration time. The results of this study show that the application of percolation theory is not limited ...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450601166494

    authors: Kimura G,Puchkov M,Betz G,Leuenberger H

    更新日期:2007-01-01 00:00:00

  • Development of a small-scale spray-drying approach for amorphous solid dispersions (ASDs) screening in early drug development.

    abstract::The present study details the development of a small-scale spray-drying approach for the routine screening of amorphous solid dispersions (ASDs). This strategy aims to overcome the limitations of standard screening methodologies like solvent casting and quench cooling to predict drug-polymer miscibility of spray-dried...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2018.1534861

    authors: Ousset A,Bassand C,Chavez PF,Meeus J,Robin F,Schubert MA,Somville P,Dodou K

    更新日期:2019-06-01 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

  • 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

  • Gastroretentive bilayer film for sustained release of atorvastatin calcium and immediate release of amlodipine besylate: pharmaceutical, pharmacokinetic evaluation, and IVIVC.

    abstract::The present study was aimed to optimize capsulated unfolding type gastroretentive bilayer film constituting immediate release (IR) layer of amlodipine besylate and sustained release (SR) layer of atorvastatin calcium. A three-factor, three-level Box-Behnken-design was used to optimize bilayer film with dual-release ch...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2019.1705486

    authors: Porwal A,Dwivedi H,Pathak K

    更新日期:2020-04-01 00:00:00

  • Physicochemical stability of bioadhesive thermoresponsive platforms for methylene blue and hypericin delivery in photodynamic therapy.

    abstract::Hypericin (Hyp), a natural hydrophobic and photoactive pigment, and methylene blue (MB), a hydrophilic cationic dye, are utilized as photosensitizer (PS) for photodynamic therapy of cancer. Bioadhesive and thermoresponsive polymeric systems can improve the drug availability by increasing the contact time between the s...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2019.1711394

    authors: Borghi-Pangoni FB,Junqueira MV,Bruschi ML

    更新日期:2020-04-01 00:00:00

  • Prolonged injectable formulation of Nafarelin using in situ gel combination delivery system.

    abstract::The principal purpose of the present study was to prepare and characterize a complex drug delivery system consisting of Nafarelin-poly (3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) nanoparticles (NPs) in combination with sodium alginate/poloxamer 407 in situ gel. Nafarelin-loaded PHBV NPs were prepared via double em...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2017.1321662

    authors: Alizadeh B,Bahari Javan N,Akbari Javar H,Khoshayand MR,Dorkoosh F

    更新日期:2018-02-01 00:00:00

  • Controlled-release drug delivery system based on fluocinolone acetonide-cyclodextrin inclusion complex incorporated in multivesicular liposomes.

    abstract::Multivesicular liposomes (MVLs) have been widely studied for encapsulation of hydrophilic drugs due to their structural properties and large aqueous inner cavities. In this study, to investigate MVLs and their potential application for incorporation of hydrophobic drugs, new drug delivery system for fluocinolone aceto...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837450.2014.920358

    authors: Vafaei SY,Dinarvand R,Esmaeili M,Mahjub R,Toliyat T

    更新日期:2015-11-01 00:00:00

  • Assessment of taste masking of captopril by ion-exchange resins using electronic gustatory system.

    abstract::The objective of the study was to mask the unpleasant taste of captopril (CPT). Taste masking was achieved by complexation of CPT with a basic ion exchange resin, Dowex® 66, using the batch method. Dowex® 66 was used for the adsorption of CPT, and physical and chemical parameters of the CPT resinates complex were eval...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2019.1687520

    authors: Chikukwa MTR,Wesoly M,Korzeniowska AB,Ciosek-Skibinska P,Walker RB,Khamanga SMM

    更新日期:2020-03-01 00:00:00

  • Casein hydrolysate as a rapid and/or enteric dissolving additive for oral drugs.

    abstract::Two types of casein hydrolysates, casein A (mean peptide length 3.3) and casein B (mean peptide length 17.4) were prepared by the enzymatic hydrolysis of casein, and their effects on in vitro dissolution rates and oral bioavailability of drugs were evaluated. The in vitro dissolution behavior of the kneaded mixture of...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.3109/10837459809028499

    authors: Imai T,Nishiyama T,Shameem M,Otagiri M

    更新日期:1998-05-01 00:00:00

  • Investigation of propellant-free aqueous foams as pharmaceutical carrier systems.

    abstract::Due to their light consistency and good spreadability, aqueous foams are considered as convenient and highly accepted drug carrier systems that are of great importance in the field of topical drug delivery. The production of a stable, easy to dose, preferably environmentally harmless foam formulation is challenging. T...

    journal_title:Pharmaceutical development and technology

    pub_type: 杂志文章

    doi:10.1080/10837450.2020.1863426

    authors: Farkas D,Kállai-Szabó N,Sárádi-Kesztyűs Á,Lengyel M,Magramane S,Kiss É,Antal I

    更新日期:2020-12-27 00:00:00