ACcelerated Dissolution Rate Analysis (ACDRA) for controlled release drugs. Application to Roxiam®

Zackrisson, Gunnar; Östling, Göran; Skagerberg, Bert; Anfält, T.

doi:10.1016/0731-7085(95)01293-t

Cited by 19 publications

(8 citation statements)

References 3 publications

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“…Recently, accelerated dissolution testing at elevated temperatures has been proposed as a means of obtaining an improved at‐line quality assurance of pharmaceutical products 6,7. In this article we propose another potentially very useful application of drug release measurements performed at different temperatures; namely to extract information about the drug release process itself by analyzing the environment and speed of the drug diffusion within the delivery vehicle.…”

Section: Introductionmentioning

confidence: 99%

Characterization of the Drug Release Process by Investigation of Its Temperature Dependence

Brohede

Frenning

Strömme

2004

Journal of Pharmaceutical Sciences

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Section: Introductionmentioning

confidence: 99%

Characterization of the Drug Release Process by Investigation of Its Temperature Dependence

Brohede

Frenning

Strömme

2004

Journal of Pharmaceutical Sciences

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“…Indeed, in vitro release testing is commonly used as a predictor of in vivo behavior, historically with traditional dosage forms like capsules and tablets (i.e., dissolution), and more recently with novel dosage forms like injectable biodegradable microspheres and implants [15][16][17]. Generally, in vitro release studies are performed at 37 ∘ C (physiological temperature), though in some instances testing at elevated temperatures has been explored to characterize drug release from a variety of dosage forms [18,19]. Some of the key objectives of in vitro release testing are one or more of the following: (f) as a compendial requirement [20,21].…”

Section: Introductionmentioning

confidence: 99%

A Review of In Vitro Drug Release Test Methods for Nano-Sized Dosage Forms

D’Souza

2014

Advances in Pharmaceutics

218

169

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This review summarizes the methods used to study real-time (37 ∘ C) drug release from nanoparticulate drug delivery systems and establish an IVIVC. Since no compendial standards exist, drug release is currently assessed using a variety of methods including sample and separate (SS), continuous flow (CF), dialysis membrane (DM) methods, and a combination thereof, as well as novel techniques like voltametry and turbidimetry. This review describes the principle of each method along with their advantages and disadvantages, including challenges with set-up and sampling. The SS method allows direct measurement of drug release with simple set-up requirements, but sampling is cumbersome. With the CF method, sampling is straightforward but the set-up is time consuming. Set-up as well as sampling is easier with the DM, but it may not be suitable for drugs that bind to the membrane. Novel methods offer the possibility of real-time drug release measurement but may be restricted to certain types of drugs. Of these methods, Level A IVIVCs have been obtained with dialysis, alone or in combination with the sample and separate technique. Future efforts should focus on developing mathematical models that describe drug release mechanisms as well as facilitate formulation development of nano-sized dosage forms.

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“…Production and distribution time may decrease by performing accelerated studies. An accelerated dissolution method could be helpful for a fast assessment of the formulation and processing variables (Zackrisson et al 1995). The accelerated dissolution method is desirable for the quality control, especially in the preparation of specifications for all product batches.…”

Section: Introductionmentioning

confidence: 99%

Acceleration of in vitro dissolution studies of sustained release dosage form of theophylline and in vitro–in vivo evaluations in terms of correlations

Ertan

Karasulu

Özgüney

et al. 2011

Eur J Drug Metab Pharmacokinet

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The aim of the study was to accelerate the dissolution of the sustained release dosage forms using both elevated temperature and high rpm rates. Teokap(®) SR 200 mg pellets were tested by in vitro sustained and accelerated dissolution studies using USP XXIII rotating paddle method. Sustained dissolution studies were carried out for 12 h in phosphate buffer at 37 ± 0.5°C and 50 rpm. Accelerated dissolution studies were performed for 48 min in distilled water at 90 ± 1°C and 250 rpm. The results obtained from accelerated and sustained dissolution studies were correlated using both linear and linear kinetic correlation methods by a computer program. While r (2) and maximum error between calculated and observed drug release rates were found to be 0.9129 and 15.9%, respectively, in linear correlation method, these values were observed as 0.9938 and 3.6%, respectively, in linear kinetic correlation method. In vivo plasma concentration data were obtained from six New Zealand rabbits after administration of a single dose of Teokap(®) SR 200 mg pellet. Then, the results of in vivo study were evaluated with in vitro accelerated and sustained dissolution results by applying them to in vitro-in vivo linear correlations. As a result of these correlations, it was shown that the in vitro correlation plots were very similar to the plot which was obtained by the in vivo study (f (2) = 73.81-77.11). This study suggested a way to prevent the loss of time for routine dissolution studies of sustained release preparations for quality control procedures using in vitro accelerated dissolution tests. The storage and quarantine periods of the product in process and process controls in the manufactories could be shortened by this method. Calculation of the in vivo performance of sustained release dosage forms using the results of the accelerated dissolution studies may be counted as another advantage of the method.

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ACcelerated Dissolution Rate Analysis (ACDRA) for controlled release drugs. Application to Roxiam®

Cited by 19 publications

References 3 publications

Characterization of the Drug Release Process by Investigation of Its Temperature Dependence

Characterization of the Drug Release Process by Investigation of Its Temperature Dependence

A Review of In Vitro Drug Release Test Methods for Nano-Sized Dosage Forms

Acceleration of in vitro dissolution studies of sustained release dosage form of theophylline and in vitro–in vivo evaluations in terms of correlations

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