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Solid dispersion application in pharmaceutical technology: Methods of preparation and characterization

Primena čvrstih disperzija u farmaceutskoj tehnologiji - postupci izrade i metode karakterizacije

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Authors
Medarević, Đorđe
Ibrić, Svetlana
Đuriš, Jelena
Đurić, Zorica
Article (Published version)
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Abstract
A growing number of newly synthesized drugs exhibit low aqueous solubility, leading to poor bioavailability. Therefore, improving drug solubility and dissolution rate became one of the greatest challenges during formulation development. Solid dispersions formulation is one of the commonly investigated techniques for improving solubility of poorly soluble drugs. Solid dispersions are dispersions of one or more drugs in an inert carrier (matrix) in the solid state prepared by melting, solvent, or melting-solvent method. Generation of drug's amorphous form, drug dissolution within the matrix, reducing particle size and agglomeration, improved wetting and drug solubilization by the carrier molecules are the main mechanisms contributing to the improvement of solubility and dissolution rate by solid dispersions formulation. However, during 50 years research of this field, only a few such preparations appeared on the market. High drug: excipients ratio, difficulties in process scale up, poor ...reproducibility of physico­chemical characteristics and problems in ensuring of long term stability are the main problems in solid dispersions formulation. It is considered that the development and improvement of industrially feasible techniques, such as hot-melt extrusion and spray drying and wider availability of techniques for physic-chemical characterization will contribute to wider application of solid dispersion technique in drugs manufacturing.

Sve veći broj novosintetisanih lekovitih supstanci pokazuje nisku rastvorljivost u vodi, što dovodi do problema u biološkoj raspoloživosti. Stoga, poboljšanje rastvorljivosti i brzine rastvaranja predstavlja jedan od najvećih izazova prilikom razvoja formulacije. Izrada čvrstih disperzija jedna je od najviše istraživanih tehnika za poboljšanje rastvorljivosti teško rastvornih lekovitih supstanci. Čvrste disperzije predstavljaju disperzije jedne ili više lekovitih supstanci u inertnom nosaču (matriksu), u čvrstom stanju, dobijene metodom topljenja, uz korišćenje rastvarača ili kombinacijom ovih metoda. Nastanak amorfne forme leka, rastvaranje leka u matriksu, smanjenje veličine čestica i njihove aglomeracije, poboljšano kvašenje i solubilizacija molekulima nosača, glavni su mehanizmi koji doprinose poboljšanju rastvorljivosti i brzine rastvaranja leka formulacijom čvrstih disperzija. Ipak, za više od 50 godina istraživanja na ovom polju, svega nekoliko preparata sa čvrstim disperzijama ...leka pojavilo se na tržištu. Visok odnos lekovita supstanca: ekscipijens, otežan prenos proizvodnje sa laboratorijskog na industrijski nivo, slaba reproduktivnost fizičko-hemijskih karakteristika i problemi sa obezbeđivanjem dugoročne stabilnosti, glavni su problemi u formulaciji čvrstih disperzija. Smatra se da će razvoj i usavršavanje industrijski primenljivih tehnika izrade, kao što su ekstruzija topljenjem i sušenje raspršivanjem, kao i sve veća dostupnost tehnika za fizičko- hemijsku karakterizaciju, doprineti široj primeni tehnike čvrstih disperzija u proizvodnji lekova.

Keywords:
solid dispersions / solubility improvement / amorphous state / hot-melt extrusion / spray drying / čvrste disperzije / poboljšanje rastvorljivosti / amorfno stanje / ekstruzija topljenjem / sušenje raspršivanjem
Source:
Arhiv za farmaciju, 2013, 63, 6, 473-493
Publisher:
  • Savez farmaceutskih udruženja Srbije, Beograd
Projects:
  • Advanced technologies for controlled release from solid drug delivery systems (RS-34007)

ISSN: 0004-1963

Scopus: 2-s2.0-84940361628
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2053
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