Pharmacokinetics of doxycycline

Linberg, L. F.; Tsirlina, L. A.; Mashilov, V P; Lisukova, T. E.; Kashin, A. M.; Alikeeva, G. K.; Kuznetsov, V. F.; Milova, O. G.

doi:10.1007/bf00758307

Cited by 3 publications

(2 citation statements)

References 3 publications

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“…Several reports in the literature have demonstrated BE of doxycycline products 37, 65, 67, 74, 75, 78–87. The study details, BE criteria, and results of the pharmacokinetic studies conducted from 1975 to 2007 are summarized in Table 2.…”

Section: Dosage Form Performancementioning

confidence: 99%

Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclateA project of the International Pharmaceutical Federation (FIP), BCS and Biowaiver, www.fip.org/bcs.This article reflects the scientific opinion of the authors and not the policies of regulating agencies, the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO).

Jantratid

Becker

Dressman

et al. 2010

Journal of Pharmaceutical Sciences

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Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing doxycycline hyclate are reviewed. According to the Biopharmaceutics Classification System (BCS), doxycycline hyclate can be assigned to BCS Class I. No problems with BE of IR doxycycline formulations containing different excipients and produced by different manufacturing methods have been reported and hence the risk of bioinequivalence caused by these factors appears to be low. Doxycycline has a wide therapeutic index. Further, BCS-based dissolution methods have been shown to be capable of identifying formulations which may dissolve too slowly to generate therapeutic levels. It is concluded that a biowaiver is appropriate for IR solid oral dosage forms containing doxycycline hyclate as the single Active Pharmaceutical Ingredient (API) provided that (a) the test product contains only excipients present in doxycycline hyclate IR solid oral drug products approved in the International Conference on Harmonization (ICH) or associated countries; and (b) the comparator and the test products comply with the BCS criteria for "very rapidly dissolving" or, alternatively, when similarity of the dissolution profiles can be demonstrated and the two products are "rapidly dissolving.".

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Section: Dosage Form Performancementioning

confidence: 99%

Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclateA project of the International Pharmaceutical Federation (FIP), BCS and Biowaiver, www.fip.org/bcs.This article reflects the scientific opinion of the authors and not the policies of regulating agencies, the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO).

Jantratid

Becker

Dressman

et al. 2010

Journal of Pharmaceutical Sciences

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“…High-performance liquid chromatography (HPLC) with UV detection was used for the determination of the above antibiotics in blood [1, 2], milk [3,4], meat, and eggs [5]. Silica gel was used as the stationary phase [1, 2], and toxic methanol was used as the mobile phase [1,2,5]. A disadvantage of the method is the long time of the separation of components (15-25 min).…”

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confidence: 99%

Fluorimetric determination of tetracyclines with the europium chelate of 1,10-phenanthroline in micellar solutions of anionic surfactants

et al. 2005

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The group of tetracycline derivatives includes compounds with the condensed tetracyclic system, which are characterized by the common antimicrobial mechanism of action. The wide use of antibiotics of this group in medicine and veterinary medicine and their high toxicity in high concentrations cause the necessity of the permanent monitoring of their concentration in biological fluids of the human body (blood, plasma, and urine) and in food (poultry, milk, and eggs). An important topic is the study of the pharmacokinetics of antibiotics in the human body.Chromatography is most frequently used for determining tetracyclines. High-performance liquid chromatography (HPLC) with UV detection was used for the determination of the above antibiotics in blood [1, 2], milk [3,4], meat, and eggs [5]. Silica gel was used as the stationary phase [1, 2], and toxic methanol was used as the mobile phase [1,2,5]. A disadvantage of the method is the long time of the separation of components (15-25 min). HPLC in combination with mass spectrometry and the internal standard (demeclocycline) was used for the determination of residual concentrations of tetracyclines in food [7-9]. The detection limits were 1 ng for oxytetracycline and 4 ng for chlortetracycline. The high cost of instrumentation and the toxicity of the mobile phase components restrict the use of HPLC in the analytical practice.Spectrophotometry is primarily used in the analysis of ready medicinals of rather simple composition [10,11]. Thus, the photometric determination of individual components of a mixture of tetracycline (1000 mg) and rifampicin (500 mg) with an error below 5% was reported [12].A biosensor was proposed for the determination of tetracycline in raw milk [13]. The detection limits of tetracycline, oxytetracycline, chlortetracycline, doxycycline, and methacycline are from 2 to 35 ng/mL. The main disadvantage of this sensor is the long response time and the high cost of the enzyme (bacterial luciferase) that is used in the sensor.One promising method for determining tetracycline is the fluorimetric method based on the formation of rare-earth metal chelates and the sensitized fluorescence generation. The sensitivity of determination is improved in the presence of the second ligand, e.g., ethylenediaminetetraacetic acid [14][15][16]]. An addition of cationic surfactants, e.g., cetyltrimethylammonium chloride additionally decreases the detection limit of tetracycline. The method was used for the determination of tetracycline in calf serum [16].Another version of the fluorimetric method is the determination of tetracycline as the europium chelate in the presence of trioctylphosphine oxide at the watertetrachloromethane phase boundary in milk and serum with a detection limit of 2 × 10 -9 M [17]. The main disadvantages of the procedure are the use of a toxic solvent and laborious operations with the flotation extract.Previously, we demonstrated that the sensitized fluorescence intensity of thenoyltrifluoroacetone chelates of europium(III) can be increased in micell...

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A bioequivalence study of two brands of doxycycline capsules

Saket

Qaisi

Razzak

et al. 1993

Current Therapeutic Research

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Pharmacokinetics of doxycycline

Cited by 3 publications

References 3 publications

Fluorimetric determination of tetracyclines with the europium chelate of 1,10-phenanthroline in micellar solutions of anionic surfactants

A bioequivalence study of two brands of doxycycline capsules

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