Elucidating Raw Material Variability—Importance of Surface Properties and Functionality in Pharmaceutical Powders

Chamarthy, Sai Prasanth; Pinal, Rodolfo; Carvajal, Micaela

doi:10.1208/s12249-009-9267-5

Cited by 42 publications

(16 citation statements)

References 40 publications

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“…The water content of the films was examined via vapor sorption techniques. [16] Upon drying films to 0% room humidity, it was determined that only 0.5% of the weight of films is due to unbound water.…”

Section: Resultsmentioning

confidence: 99%

Water soluble polymer films for intravascular drug delivery of antithrombotic biomolecules

Scott¹,

Park

Panitch³

2013

European Journal of Pharmaceutics and Biopharmaceutics

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Over the past 10 years, the number of percutaneous coronary intervention (PCI) procedures performed in the United States has increased by 33%; however, restenosis, which inhibits complete functional recovery of the vessel wall, remains a complication of this procedure. To traverse the complications associated with PCI, the investigation of therapeutic delivery has become an integral topic in modern research. One such therapeutic, a mimic of the proteoglycan decorin, termed DS-SILY, can mask exposed collagen and thereby effectively decrease platelet activation, has recently been developed by our lab. Drawing inspiration from coating technologies developed by the pharmaceutical industry, a fast-dissolving polymer film has been developed to deliver active therapeutic agents from a balloon catheter during PCI. This research investigates the release of DS-SILY from fast-dissolving polymer films composed of poly(vinyl alcohol) (PVA) and poly(ethylene glycol) (PEG). Thin, uniform polymer films were produced via spin coating technique. The dissolution speed of the polymer films was found to be dependent on the concentration of polymer solution, where at least 65% of the films were shown to dissolve into nanometer sized polymer fragments within two minutes. DS-SILY, up to 6.26 μg/cm2, was loaded into the films and functional release of the mimic was demonstrated by its successful binding to collagen upon release. Furthermore, DS-SILY released from films resulted in increased platelet inhibition. These results indicate that use of fast-dissolving polymer films allow for the successful release of biomolecules and further investigation of their use for localized drug delivery during PCI procedures is warranted.

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Section: Resultsmentioning

confidence: 99%

Water soluble polymer films for intravascular drug delivery of antithrombotic biomolecules

Scott¹,

Park

Panitch³

2013

European Journal of Pharmaceutics and Biopharmaceutics

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“…Zbog mogućih problema u lancu snabdevanja, poželjno je da svaki proizvođač lekova ima više od jednog potencijalnih dobavljača ekscipijenasa (13). Pronalaženje alternativnih proizvođača eskcipijenasa znatno otežava velika varijabilnost nekih karakteristika ekscipijenasa, koja može uticati na kvalitet finalnog proizvoda.…”

Section: Varijabilnost (Promenljivost Karakteristika) Ekscipijenasaunclassified

“…uvođenje dodatnog ispiranja rastvorljivog skroba (Starch, soluble), tokom procesa proizvodnje ovog ekscipijensa, ima značajan uticaj na njegovu kompaktibilnost. Iako ovaj postupak ne utiče na veličinu čestica, specifičnu površinu, vezivanje vlage, prividni kristalinitet i izgled FT-IR spektra, on dovodi do povećanja površinske energije, pa ovako obrađen skrob formira znatno čvršće komprimate (13).…”

Section: Varijabilnost (Promenljivost Karakteristika) Ekscipijenasaunclassified

Excipients functionality: Importance and compendial status

Milić¹,

Čalija²,

Krajišnik³

2016

Arh farmaciju

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Saznanje da pomoćne supstance/ekscipijensi mogu značajno uticati na kvalitet, bezbednost i efikasnost lekova u potpunosti je izmenilo tradicionalno shvatanje ekscipijenasa kao jednostavnih, inertnih i neaktivnih sastojaka farmaceutskog oblika leka. Da bi se izradio/proizveo lek prihvatljivog kvaliteta neophodno je, pored ostalog, identifikovati one karakteristike ekscipijenasa koje su od značaja za njihovu ulogu u farmaceutskom preparatu/proizvodu, ispitati na koji način i u kojoj meri te karakteristike utiču na konkretnu ulogu, a potom definisati opsege prihvatljivih vrednosti tih karakteristika. Ove karakteristike ekscipijenasa nazivaju se funkcionalnim karakteristikama, a način na koji, i stepen u kome ekscipijensi ostvaruju namenjenu ulogu u konačnoj formulaciji, definišu se kao njihova funkcionalnost. Funkcionalnost ekscipijenasa zavisi i od konačne formulacije leka i postupka njegove izrade/proizvodnje, te se zbog toga ne može generalizovati, nego se može posmatrati samo u odnosu na konkretan lek, određenog sastava, koji se dobija određenim proizvodnim procesom/postupkom izrade.U ovom radu biće reči o definiciji, značaju i farmakopejskom statusu funkcionalnosti i funkcionalnih karakteristika ekscipijenasa, te o funkcionalnim karakteristikama kao kritičnim svojstvima kvaliteta leka, sa stanovišta QbD pristupa razvoju leka.

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“…This may have been due to the exposure of different facets and/or acidic functional groups on the material surface after processing. The effects of processing on the surface energies of different materials have been previously investigated (43)(44)(45)(46). For example, milled lactose has a higher dispersive surface energy than spray-dried particles (47).…”

Section: Surface Energy Of Spray-dried and Milled Samplesmentioning

confidence: 99%

Theophylline Cocrystals Prepared by Spray Drying: Physicochemical Properties and Aerosolization Performance

et al. 2013

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Abstract. The purpose of this work was to characterize theophylline (THF) cocrystals prepared by spray drying in terms of the physicochemical properties and inhalation performance when aerosolized from a dry powder inhaler. Cocrystals of theophylline with urea (THF-URE), saccharin (THF-SAC) and nicotinamide (THF-NIC) were prepared by spray drying. Milled THF and THF-SAC cocrystals were also used for comparison. The physical purity, particle size, particle morphology and surface energy of the materials were determined. The in vitro aerosol performance of the spray-dried cocrystals, drug-alone and a drugcarrier aerosol, was assessed. The spray-dried particles had different size distributions, morphologies and surface energies. The milled samples had higher surface energy than those prepared by spray drying. Good agreement was observed between multi-stage liquid impinger and next-generation impactor in terms of assessing spray-dried THF particles. The fine particle fractions of both formulations were similar for THF, but drug-alone formulations outperformed drug-carrier formulations for the THF cocrystals. The aerosolization performance of different THF cocrystals was within the following rank order as obtained from both drug-alone and drug-carrier formulations: THF-NIC>THF-URE>THF-SAC. It was proposed that micromeritic properties dominate over particle surface energy in terms of determining the aerosol performance of THF cocrystals. Spray drying could be a potential technique for preparing cocrystals with modified physical properties.

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Elucidating Raw Material Variability—Importance of Surface Properties and Functionality in Pharmaceutical Powders

Cited by 42 publications

References 40 publications

Water soluble polymer films for intravascular drug delivery of antithrombotic biomolecules

Water soluble polymer films for intravascular drug delivery of antithrombotic biomolecules

Excipients functionality: Importance and compendial status

Theophylline Cocrystals Prepared by Spray Drying: Physicochemical Properties and Aerosolization Performance

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