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Quintessence International (Berlin,... Sep 2022Doxycycline hyclate is a controlled-release doxycycline polymer which can locally be applied. This study aimed to assess the effects of the prophylactic application of... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
Doxycycline hyclate is a controlled-release doxycycline polymer which can locally be applied. This study aimed to assess the effects of the prophylactic application of doxycycline hyclate at the implant-abutment interface on the short-term outcomes of implant therapy.
METHOD AND MATERIALS
The present split-mouth randomized clinical trial included 20 subjects who received two mandibular implants bilaterally (40 implants in total). In the test side (n = 20), doxycycline hyclate was injected at the implant-abutment interface at the time of delivery of final prosthesis. No intervention was performed for the control side (n = 20). The marginal bone level on mesial and distal implant surfaces, bleeding on probing, pocket probing depth, and incidence of peri-implant mucositis were recorded at baseline and after 3, 6, and 12 months.
RESULTS
Significant differences were found between the test and control sites, all favoring the test group, for marginal bone level changes at mesial and distal implant surfaces as well as for changes in pocket probing depth after 6 and 12 months. Furthermore, the numbers of implants with bleeding on probing and risk of developing peri-implant mucositis were significantly greater in the control group compared to the test group at 3-months, 6-months, and 12-months following baseline.
CONCLUSIONS
Within the limitations of this study, it can be concluded that prophylactic application of doxycycline hyclate at the implant-abutment interface results in reduced crestal bone resorption and pocket probing depth levels. In addition, it reduces the risk of developing peri-implant mucositis.
Topics: Alveolar Bone Loss; Delayed-Action Preparations; Dental Implantation, Endosseous; Dental Implants; Doxycycline; Humans; Mucositis
PubMed: 36112019
DOI: 10.3290/j.qi.b3320823 -
Skinmed 2006
Topics: Doxycycline; Humans; Rosacea
PubMed: 16957435
DOI: 10.1111/j.1540-9740.2006.5025.x -
Pharmacokinetics of an injectable long-acting parenteral formulation of doxycycline hyclate in pigs.Journal of Veterinary Pharmacology and... Feb 2014Based on its ideal PK/PD ratios, doxycycline hyclate (DOX-h), a time-dependant antibacterial, is ideally expected to achieve sustained plasma drug concentrations at or... (Clinical Trial)
Clinical Trial
Based on its ideal PK/PD ratios, doxycycline hyclate (DOX-h), a time-dependant antibacterial, is ideally expected to achieve sustained plasma drug concentrations at or slightly above the MIC level for as long as possible between dosing intervals. Pursuing this end, a poloxamer-based matrix was used to produce a 10% long-acting injectable preparation (DOX-h-LA) and its serum concentrations vs. time profile investigated after its injection to pigs in the pericaudal s.c. by parallel design. Results were compared with the forced oral bolus dose and i.v. pharmacokinetics of DOX-h. For this study, 12 recently weaned pigs per group were included in this trial, and a dose of 20 mg/kg was injected in all cases. DOX-h-LA showed the greatest values for bioavailability (115.38%); maximum serum concentration (Cmax) value was 1.5 ± 0.2 with a time to reach Cmax of 3.41 ± 0.04 h and an elimination rate constant of 70.93 ± 0.87( ) h. Considering minimum effective serum concentration of 0.5 μg/mL, a dose interval of at least 5 days can be achieved for DOX-h-LA, whereas p.o. and i.v. dosing of DOX-h may only last 11 and 15 h, respectively. Pigs were slaughtered on day 30 after this trial, and no visible remnants of the preparation were detected neither fibrosis was observed after a thorough macroscopic and histopathological analysis.
Topics: Animals; Anti-Bacterial Agents; Area Under Curve; Biological Availability; Delayed-Action Preparations; Doxycycline; Half-Life; Injections, Subcutaneous; Microbial Sensitivity Tests; Swine
PubMed: 23866042
DOI: 10.1111/jvp.12066 -
International Journal of Clinical... Jul 2004This investigation was carried out to evaluate the bioavailability of a new capsule formulation of doxycycline (100 mg), doxycin, relative to the reference product,... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
Comparative bioavailability study of doxycycline hyclate (equivalent to 100 mg doxycycline) capsules (doxycin vs vibramycin) for bioequivalence evaluation in healthy adult volunteers.
This investigation was carried out to evaluate the bioavailability of a new capsule formulation of doxycycline (100 mg), doxycin, relative to the reference product, vibramycin (100 mg) capsules. The bioavailability was carried out in 24 healthy male volunteers who received a single dose (100 mg) of the test (A) and the reference (B) products after an overnight fast of at least 10 hours on 2 treatment days. The treatment periods were separated by a 2-week washout period. A randomized, balanced 2-way cross-over design was used. After dosing, serial blood samples were collected for a period of 48 hours. Plasma concentrations of doxycycline were analyzed by a sensitive and validated high-performance liquid chromatography assay. The pharmacokinetic parameters for doxycycline were determined using standard noncompartmental methods. The parameters AUC(0-t), AUC(0-infinity), Cmax, K(el), t(1/2) and Cmax/AUC(0-infinity) were analyzed statistically using log-transformed data. The time to maximum concentration (tmax) was analyzed using raw data. The parametric 90% confidence intervals of the mean values of the pharmacokinetic parameters: AUC(0-t), AUC(0-infinity), Cmax and Cmax/AUC(0-infinity) were within the range 80-125% which is acceptable for bioequivalence (using log-transformed data). The calculated 90% confidence intervals based on the ANOVA analysis of the mean test/reference ratios of AUC(0-t), AUC(0-infinity), Cmax and Cmax/AUC(0-infinity) were 95.98-109.56%, 92.21 to 107.66%, 93.90-112.56%, and 96.0 to 106.91% respectively. The test formulation was found bioequivalent to the reference formulation with regard to AUC(0-t), AUC(0-infinity), Cmax and Cmax/AUC(0-infinity) by the Schuirmann's two 1-sided t-tests. Therefore, the 2 formulations were considered to be bioequivalent.
Topics: Administration, Oral; Adult; Anti-Bacterial Agents; Area Under Curve; Biological Availability; Capsules; Chromatography, High Pressure Liquid; Cross-Over Studies; Doxycycline; Humans; Male; Therapeutic Equivalency; Time Factors
PubMed: 15605689
DOI: 10.5414/cpp42373 -
ELife Nov 2020Doxycycline (DOX) is a key antimalarial drug thought to kill parasites by blocking protein translation in the essential apicoplast organelle. Clinical use is primarily...
Doxycycline (DOX) is a key antimalarial drug thought to kill parasites by blocking protein translation in the essential apicoplast organelle. Clinical use is primarily limited to prophylaxis due to delayed second-cycle parasite death at 1-3 µM serum concentrations. DOX concentrations > 5 µM kill parasites with first-cycle activity but are thought to involve off-target mechanisms outside the apicoplast. We report that 10 µM DOX blocks apicoplast biogenesis in the first cycle and is rescued by isopentenyl pyrophosphate, an essential apicoplast product, confirming an apicoplast-specific mechanism. Exogenous iron rescues parasites and apicoplast biogenesis from first- but not second-cycle effects of 10 µM DOX, revealing that first-cycle activity involves a metal-dependent mechanism distinct from the delayed-death mechanism. These results critically expand the paradigm for understanding the fundamental antiparasitic mechanisms of DOX and suggest repurposing DOX as a faster acting antimalarial at higher dosing whose multiple mechanisms would be expected to limit parasite resistance.
Topics: Antimalarials; Apicoplasts; Doxycycline; Molecular Structure; Plasmodium falciparum
PubMed: 33135634
DOI: 10.7554/eLife.60246 -
Journal of Periodontology Feb 2005Clinical studies using locally applied doxycycline hyclate (DHV) have demonstrated significant probing depth reduction and gain in clinical attachment as a monotherapy... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
BACKGROUND
Clinical studies using locally applied doxycycline hyclate (DHV) have demonstrated significant probing depth reduction and gain in clinical attachment as a monotherapy without scaling and root planing. The mechanism for this attachment level gain to the non-root planed tooth is not understood. The purpose of this study was to investigate the effect of locally applied doxycycline hyclate on human gingival fibroblast attachment to subgingival calculus on contaminated root surfaces.
METHODS
Two separate experiments were performed, both on subgingival calculus. In experiment 1, teeth with subgingival calculus were treated with either doxcycycline hyclate in bioabsorbable vehicle (DHV) or with vehicle control (VC) in vivo. In experiment 2, teeth with subgingival calculus were treated with DHV, VC, scaling and root planing (SRP), or no treatment in vitro. The amount of cell attachment to calculus-covered root surfaces was quantitatively compared using a fluorescent dye assay and epifluorescence microscope. Values for cell attachment are presented as the mean standard deviation of the mean. The data were evaluated using Student t test.
RESULTS
In both experiments, there was no statistically significant difference in fibroblast attachment in the DHV, VC, or no treatment groups (P >0.05). The SRP group showed significantly more cellular attachment to tooth surfaces formerly covered by subgingival calculus than all other groups (P <0.001). In general, more cells attached to cementum than to calculus. Root chips that showed no attachment to the subgingival calculus also had no cells attached to the adjacent cemental root surface.
CONCLUSION
The addition of doxycycline hyclate in a bioabsorbable vehicle used as a locally delivered drug did not enhance the initial cellular attachment of human gingival fibroblasts to subgingival calculus or contaminated root surfaces.
Topics: Absorbable Implants; Anti-Bacterial Agents; Cell Adhesion; Cells, Cultured; Dental Calculus; Dental Cementum; Dental Scaling; Doxycycline; Fibroblasts; Gingiva; Humans; Pharmaceutical Vehicles; Polyesters
PubMed: 15974845
DOI: 10.1902/jop.2005.76.2.221 -
Ophthalmic Plastic and Reconstructive... 2019To investigate the safety and efficacy of direct, intralesional doxycycline hyclate injection for improving the appearance of cosmetically significant lower eyelid...
PURPOSE
To investigate the safety and efficacy of direct, intralesional doxycycline hyclate injection for improving the appearance of cosmetically significant lower eyelid festoons and malar edema.
METHODS
An Institutional Review Board approved, retrospective review was performed of 15 consecutive patients with malar edema and/or festoons injected with doxycycline hyclate at a concentration of 10 mg/ml. Pre- and postinjection photographs were reviewed and graded on a scale of 0 to 3 (0: no festoon; 1: small festoon; 2: medium festoon; 3: large festoon) by 2 masked physician observers. Patients were excluded from the final analysis if they received an alternate dose concentration, had incomplete photographic records, or did not follow up. Student t test was used for statistical analysis.
RESULTS
Twenty consecutive treatment areas of 11 patients were included in the analysis. Final follow up ranged from 3 to 104 weeks, with a mean follow up of 22.5 weeks. The average (standard deviation) initial festoon grade of 2.5 (0.58) decreased to 0.9 (0.82) with a p value of <0.001. The average number of injections performed per side was 1.4 (range: 1-2). The mean volume per injection was 0.72 ml (range: 0.15-2.0 ml). Commonly documented subjective complaints were burning sensation with injection, pain, bruising, and erythema. There were no other dermatologic or visual complications following treatment.
CONCLUSIONS
These preliminary results suggest that intralesional injections of doxycycline hyclate at a concentration of 10 mg/ml may be an effective treatment option for cosmetically significant lower eyelid festoons and malar edema. Future prospective studies with increased patient numbers, increasing concentrations, combination therapies with local anesthetic or regional nerve blocks, and longer follow up are needed to validate these results and determine optimal injection technique.
Topics: Aged; Anti-Bacterial Agents; Doxycycline; Edema; Eyelid Diseases; Female; Humans; Male; Middle Aged; Sclerotherapy
PubMed: 30882591
DOI: 10.1097/IOP.0000000000001332 -
Acta Pharmaceutica (Zagreb, Croatia) Dec 2010A spectrophotometric method for the determination of doxycycline (DOX) is described. The method is based on the formation of blue colored chromogen due to reduction of...
A spectrophotometric method for the determination of doxycycline (DOX) is described. The method is based on the formation of blue colored chromogen due to reduction of tungstate and/or molybdate in Folin-Ciocalteu (F-C) reagent by DOX in alkaline medium. The colored species has an absorption maximum at 770 nm and the system obeys Beer's law over the concentration range 0.75-12.0 μg mL-1 DOX. The apparent molar absorptivity is 2.78 × 104 L mol-1 cm-1. The limit of quantification and detection values are reported to be 0.20 and 0.08 μg mL-1, respectively. Over the linear range applicable, the accuracy and precision of the method were evaluated on intra-day and inter-day basis. The reported mean accuracy value was 101.0 ± 1.7 %, the relative error was ≤ 2.7 % and the relative standard deviation was ≤ 2.5 %. Application of the proposed method to bulk powder and commercial pharmaceutical tablets is also presented. No significant difference was obtained between the results of the proposed method and the official BP method. The procedure described in this paper is simple, rapid, accurate and precise.
Topics: Anti-Bacterial Agents; Doxycycline; Humans; Indicators and Reagents; Molybdenum; Powders; Reproducibility of Results; Sensitivity and Specificity; Spectrophotometry; Tablets; Tungsten Compounds
PubMed: 21169136
DOI: 10.2478/v10007-010-0032-9 -
Journal of the American Veterinary... Jun 2013To determine the concentration of doxycycline compounded from doxycycline hyclate tablets into liquid formulations for oral administration in veterinary species and...
OBJECTIVE
To determine the concentration of doxycycline compounded from doxycycline hyclate tablets into liquid formulations for oral administration in veterinary species and stored for 28 days.
DESIGN
Evaluation study.
SAMPLE
Doxycycline hyclate tablets (100 mg) crushed and mixed with a 50:50 mixture of syrup and suspension vehicles for oral administration to produce 3 batches each of 2 doxycycline formulations: 33.3 and 166.7 mg/mL.
PROCEDURES
Formulations were stored, protected from light, at room temperature (22° to 26°C [71.6° to 78.8°F]) and at a controlled cold temperature (refrigerated 2° to 8°C [35.6° to 46.4°F]). Doxycycline was extracted from the formulations, and concentration was measured by high-pressure liquid chromatography on days 0 (date of preparation), 1, 4, 7, 14, 21, and 28. Concentrations were compared with those of a US Pharmacopeial Convention reference standard. Formulation quality at each point was also assessed through color change, formulation consistency, and suspension uniformity.
RESULTS
On days 0, 1, 4, and 7, the concentration of each formulation was within 90% to 110% of the reference standard (range, 93% to 109%), which was deemed acceptable. However, doxycycline concentrations had decreased dramatically by day 14 and remained low for the duration of the study period. Doxycycline concentrations on days 14, 21, and 28 were all < 20% (range, 14% to 18%) of the reference standard, and the quality of the formulations decreased as well. No effect of storage temperatures on doxycycline concentration was identified.
CONCLUSIONS AND CLINICAL RELEVANCE
The concentration of doxycycline, compounded from commercial tablets in the vehicles evaluated to yield doses of 33.3 and 166.7 mg/mL, cannot be assured beyond 7 days.
Topics: Anti-Bacterial Agents; Chemistry, Pharmaceutical; Doxycycline; Drug Compounding; Drug Stability; Drug Storage; Suspensions; Time Factors; Veterinary Drugs
PubMed: 23725430
DOI: 10.2460/javma.242.12.1674 -
Bulletin of the World Health... 1976Doxycycline was compared with tetracycline in the treatment of cholera. Four types of treatment were compared: Group A was given 200 mg of doxycycline on admission and... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
Doxycycline was compared with tetracycline in the treatment of cholera. Four types of treatment were compared: Group A was given 200 mg of doxycycline on admission and 100 mg on the second day; Group B was given 200 mg of doxycycline on admission only; Group C was given 300 mg of doxycycline on admission only; and Group D received 500 mg of tetracycline every 6 h for 48 h. Tetracycline showed a slight advantage in respect of duration of diarrhoea and vibrio excretion compared with doxycycline given as a single dose of 300 mg, but fluid intake and output were about the same in these two groups. The other two doxycycline treatment schedules did not compare well with tetracycline treatment.
Topics: Adolescent; Adult; Aged; Child; Cholera; Doxycycline; Drug Evaluation; Humans; Male; Middle Aged; Tetracycline
PubMed: 1088099
DOI: No ID Found