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Jens Peter Norgaard - One of the best experts on this subject based on the ideXlab platform.
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the nocturia impact diary a self reported impact measure to complement the voiding diary
Value in Health, 2014Co-Authors: Tove Holmlarsen, Raymond C. Rosen, Fredrik L Andersson, Egbert Van Der Meulen, Vladimir Yankov, Jens Peter NorgaardAbstract:Background: Nocturia is a chronic, fluctuating disease that disrupts sleep and has a wide-ranging impact on quality of life. Valid tools to measure the patient-reported impact of nocturia are essential for evaluating the value of treatment, but the available tools are suboptimal. Objectives: This study reports the development and validation of the Nocturia Impact Diary—an augmented form of the Nocturia Quality of Life questionnaire designed to be completed in conjunction with the widely used 3-day voiding diary. Methods: The process comprised three steps: Step 1: Development of a concept pool using the Nocturia Quality of Life questionnaire and data from relevant studies; Step 2: Content validity study; Step 3: Psychometric testing of construct validity, reliability, and sensitivity of the diary in a randomized, placebo-controlled study in patients with nocturia. Results: Step 1: Fourteen items and 4 domains were included in the first draft of the diary. Step 2: Twenty-three patients with nocturia participated in the cognitive debriefing study. Items were adjusted accordingly, and the content validity was high. Step 3: Fifty-six patients were randomized to desmopressin Orally Disintegrating Tablet or placebo. The diary demonstrated high construct validity, with good sensitivity and a good fit to Rasch model, as well as high internal consistency, discriminatory ability, and acceptable sensitivity to change. Results indicated that the diary was unidimensional. Conclusions: The Nocturia Impact Diary is a convenient, validated patient-reported outcome measure. It should be used in conjunction with a voiding diary to capture the real-life consequences of nocturia and its treatment.
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gender difference in efficacy and dose response in japanese patients with nocturia treated with four different doses of desmopressin Orally Disintegrating Tablet in a randomized placebo controlled trial
BJUI, 2013Co-Authors: Osamu Yamaguchi, Kristian Vinter Juul, Osamu Nishizawa, Jens Peter NorgaardAbstract:What's known on the subject? and What does the study add? Desmopressin Orally Disintegrating Tablet (ODT) 60–240 μg has proved an effective and well-tolerated antidiuretic treatment in male and female patients with nocturia. The main adverse event is hyponatraemia. Recent studies suggest that female patients are more sensitive to desmopressin ODT, achieving the same efficacy at lower doses than male patients. The study demonstrates the efficacy of desmopressin ODT in male and female Japanese patients with nocturia. It provides further evidence that the optimum desmopressin dose for the treatment of nocturia is lower in females than in males. Tailoring the dose according to gender provides an improved therapeutic window with the benefits of a decreased risk of hyponatraemia without compromising efficacy. Objectives To establish the dose–response efficacy of desmopressin in a Japanese patient population for the treatment of nocturia. To explore gender differences in sensitivity to desmopressin in Japanese patients with nocturia. Patients and Methods A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted. Subjects aged 55–75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin Orally Disintegrating Tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg. The dose–response relationship of pharmacodynamic variables measured after a single dose of desmopressin administered to water-loaded subjects (treatment period 1) was compared with the primary clinical endpoint of change from baseline in mean number of nocturnal voids, after 28 days of desmopressin treatment (treatment period 2). Results A total of 116 patients were treated in treatment period 1 of whom 113 qualified for treatment period 2, and 111 completed the study. In treatment period 1 a dose–response relationship was observed, both overall and in each gender group. Overall, the duration of antidiuretic action (DOA; time with urine osmolality >200 mOsm/kg) for the 25, 50 and 100 μg doses was 2 h (P = 0.010), 3.45 h (P < 0.001) and 5.74 h (P < 0.001), respectively; all statistically significant compared with placebo. Female patients were found to be more sensitive to desmopressin; DOA in female patients was longer than in male patients after desmopressin 25 and 50 μg. Extrapolation suggests that male patients require ∼58 μg to achieve similar DOA to females receiving 25 μg. A dose–response relationship was also seen in treatment period 2 for the group overall with a greater reduction in mean number of nocturnal voids from baseline to day 28 at higher doses, and with significant reductions in the 25- (P = 0.015) 50- (P < 0.001) and 100-μg (P = 0.001) dose groups compared with placebo. Similar dose–response relationships were also seen when the data were analysed by gender. Desmopressin ODT was well tolerated with no serious or severe adverse events. Conclusions A dose–response relationship for desmopressin ODT was shown in a population of Japanese patients with nocturia. The study suggests that the optimum desmopressin dose for the treatment of nocturia is lower in females than in males, indicating a gender-specific therapeutic window with a decreased risk of hyponatraemia without compromising efficacy on reduction of nocturnal voids. Further dose-finding studies are planned to confirm the recommended dose for the treatment of nocturia in a Japanese patient population.
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efficacy and safety of desmopressin Orally Disintegrating Tablet in patients with central diabetes insipidus results of a multicenter open label dose titration study
Endocrine Journal, 2013Co-Authors: Hiroshi Arima, Kristian Vinter Juul, Yutaka Oiso, Jens Peter NorgaardAbstract:: Central diabetes insipidus (CDI) is associated with arginine vasopressin (AVP) deficiency with resultant polyuria and polydipsia. Intranasal desmopressin provides physiological replacement but oral formulations are preferred for their ease of administration. This study aimed to demonstrate the efficacy and safety of desmopressin Orally Disintegrating Tablet (ODT) in the treatment of Japanese patients with CDI, and confirm that antidiuresis is maintained on switching from intranasal desmopressin to desmopressin ODT. A total of 20 patients aged 6-75 years with CDI were included in this 4-week multicenter, open-label study. Following observation, patients switched from intranasal desmopressin to desmopressin ODT with titration to optimal dose over ≤5 days at the study site. Following three consecutive doses with stable patient fluid balance, patients were discharged with visits at Weeks 2 and 4. Following titration from intranasal desmopressin to ODT, the mean 24-hour urine volume was unchanged, indicating similar antidiuresis with both formulations. The proportion of patients with endpoint measurements (urine osmolality, 24-hour urine volume, hourly diuresis rate and urine-specific gravity) within normal range at Days 1-2 (intranasal desmopressin) and Week 4 (desmopressin ODT) was similar. The mean daily dose ratio of intranasal desmopressin to desmopressin ODT (Week 4) was 1:24 but a wide range was observed across individuals to maintain adequate antidiuretic effect. Hyponatraemia was generally mild and managed by dose titration. Desmopressin ODT achieved sufficient antidiuretic control compared to intranasal therapy and was well tolerated over long-term treatment. The wide range of intranasal:ODT dose ratios underline the importance of individual titration.
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desmopressin Orally Disintegrating Tablet effectively reduces nocturia results of a randomized double blind placebo controlled trial
Neurourology and Urodynamics, 2012Co-Authors: Jeffrey P Weiss, Norman R Zinner, Bjarke Mirner Klein, Jens Peter NorgaardAbstract:Aims The primary objective was to investigate the efficacy of desmopressin Orally Disintegrating Tablet versus placebo in patients with nocturia. Pharmacodynamics, safety and patient-reported quality of life (QoL) outcomes were also evaluated. One of several benefits of the new formulation is increased bioavailability. Exploring lower doses allows for a better evaluation of therapeutic effect versus tolerability. Methods This was a 4-week, randomized, double-blind study comparing 10, 25, 50, or 100 µg desmopressin versus placebo in adults with defined nocturia. Results The intent to treat population comprised 757 patients experiencing ∼3 voids/night and a high prevalence of nocturnal polyuria (∼90%). Increasing doses of desmopressin were associated with decreasing numbers of nocturnal voids and voided volume, greater proportions of subjects with >33% reduction in nocturnal voids, and increased duration of first sleep period. The lowest dose reaching statistical significance (P 25 µg desmopressin) and two men (aged 67 and 82) taking 100 µg, support lower and gender-specific dosing to reduce the small but clinically significant risk of hyponatraemia. Each void reduced/hour of sleep gained was associated with significant improvements in QoL. Conclusions Desmopressin Orally Disintegrating Tablet is an effective and well-tolerated treatment for patients with nocturia. Further exploration of the lower dose range is warranted. Neurourol. Urodynam. 31:441–447, 2012. © 2012 Wiley Periodicals, Inc.
Sai Nudurupati - One of the best experts on this subject based on the ideXlab platform.
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bioavailability of a dexlansoprazole delayed release Orally Disintegrating Tablet effects of food and mode of administration
Clinical and Experimental Gastroenterology, 2017Co-Authors: Michael Kukulka, Sai NudurupatiAbstract:Background Dexlansoprazole is a proton pump inhibitor (PPI) approved for use in dual delayed-release capsule and Orally Disintegrating Tablet (ODT) formulations. Aim To assess effects of food, water, and route of administration on the bioavailability of dexlansoprazole 30-mg ODT. Methods Two separate open-label, phase 1, single-dose crossover studies were conducted in healthy adults. In study 1, pharmacokinetic parameters were analyzed in participants receiving dexlansoprazole ODT in a fed or fasted state with and without water. In study 2, the bioavailability of dexlansoprazole after administration via oral syringe or nasogastric (NG) tube, or after swallowing intact with water was compared to ODT administration in the fasted state, swallowed without water. Blood samples for determining dexlansoprazole plasma concentrations and pharmacokinetic parameter estimates were collected before and after dosing. Results Equivalent values for area under the plasma concentration-time curve (AUC) were observed in the fed and fasted states, but the maximum observed plasma concentration (Cmax) was 38% lower in the fed state; therefore, bioequivalence was not achieved. A water rinse following standard ODT administration decreased dexlansoprazole bioavailability, with lower Cmax and AUC values than when ODT was administered without a water rinse. Bioequivalence was demonstrated when comparing the alternative routes of administration, including via oral syringe or NG tube with standard ODT administration. Unlike with a water rinse, bioequivalence to standard ODT administration (i.e., without water) was demonstrated when swallowing the ODT intact with water. Rates of adverse events were comparable irrespective of administration route in the fasted state (6.7%-9.3%) and were 12% higher in the fed state than in the fasted state. Conclusion The AUC from the dexlansoprazole ODT was equivalent when administered in the fed and fasted states. Equivalent systemic exposure to dexlansoprazole was achieved regardless of the administration route.
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pharmacokinetics and pharmacodynamics of an Orally Disintegrating Tablet formulation of dexlansoprazole
Therapeutic Advances in Gastroenterology, 2016Co-Authors: Michael Kukulka, Sai NudurupatiAbstract:Background:The pharmacokinetics and pharmacodynamics of a novel Orally Disintegrating Tablet (ODT) formulation of delayed-release dexlansoprazole 30 mg was evaluated versus the dexlansoprazole 30 mg capsule in this phase I, open-label, multiple-dose, randomized, two-period crossover study.Methods:Healthy adults received daily doses of 30 mg dexlansoprazole ODT or 30 mg dexlansoprazole delayed-release capsule for 5 days during two treatment periods, separated by a 7-day washout interval. Blood samples for dexlansoprazole plasma concentrations and intragastric pH measurements were collected through 24 hours postdose on days 1 and 5 of each period.Results:Bioequivalence between the 30 mg ODT and 30 mg capsule dosage forms was demonstrated by the primary endpoints of dexlansoprazole peak concentration (Cmax) and systemic exposure (AUC) values contained within the prespecified 90% confidence interval (CI) range of 0.80–1.25. Additional primary endpoints of intragastric mean pH values and percentage of time wit...
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bioavailability safety and pharmacodynamics of delayed release dexlansoprazole administered as two 30 mg Orally Disintegrating Tablets or one 60 mg capsule
Therapeutic Advances in Gastroenterology, 2016Co-Authors: Michael Kukulka, Sai NudurupatiAbstract:Background:Dual delayed-release dexlansoprazole is approved for use in adults as a 30 mg Orally Disintegrating Tablet (ODT) or as 30 mg and 60 mg capsules. The pharmacokinetics, pharmacodynamics, and safety profile of two dexlansoprazole 30 mg ODTs were compared with one dexlansoprazole 60 mg capsule in this randomized, phase I, open-label, single-center, multiple-dose, two-period crossover study.Methods:Participants were randomized in one of two treatment sequences, each comprised two 5-day treatment periods during which two dexlansoprazole 30 mg ODTs or one 60 mg capsule was administered once daily. Pharmacokinetic parameters and the mean intragastric pH profile for the 24-hour period after dosing on days 1 and 5 were described. Adverse events were monitored during study duration and followed up with a phone call 5–10 days after the last dose of study drug.Results:On day 1, peak observed plasma concentration (Cmax) values were similar between two 30 mg ODTs (1047 ng/ml) and one 60 mg capsule (1164 ng/ml...
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Pharmacokinetics and pharmacodynamics of an Orally Disintegrating Tablet formulation of dexlansoprazole
'SAGE Publications', 2016Co-Authors: Michael Kukulka, Sai NudurupatiAbstract:Background: The pharmacokinetics and pharmacodynamics of a novel Orally Disintegrating Tablet (ODT) formulation of delayed-release dexlansoprazole 30 mg was evaluated versus the dexlansoprazole 30 mg capsule in this phase I, open-label, multiple-dose, randomized, two-period crossover study. Methods: Healthy adults received daily doses of 30 mg dexlansoprazole ODT or 30 mg dexlansoprazole delayed-release capsule for 5 days during two treatment periods, separated by a 7-day washout interval. Blood samples for dexlansoprazole plasma concentrations and intragastric pH measurements were collected through 24 hours postdose on days 1 and 5 of each period. Results: Bioequivalence between the 30 mg ODT and 30 mg capsule dosage forms was demonstrated by the primary endpoints of dexlansoprazole peak concentration ( C max ) and systemic exposure (AUC) values contained within the prespecified 90% confidence interval (CI) range of 0.80–1.25. Additional primary endpoints of intragastric mean pH values and percentage of time with pH > 4 over the 24-hour postdose interval were equivalent for dexlansoprazole ODT and dexlansoprazole capsule. Treatment-emergent adverse events were reported in 23% and 28% of participants receiving the ODT and capsule formulations, respectively. Headache was the most common adverse event in both treatment regimens (5.8% with ODT and 6.0% with capsule). Conclusions: Administration of dexlansoprazole 30 mg ODT or 30 mg capsule provided equivalent plasma exposure when either was administered as a single dose or as once daily doses for 5 days. Pharmacodynamic equivalence between the two formulations was demonstrated by similar intragastric pH parameters on both day 1 and day 5. No effect of day on dexlansoprazole pharmacokinetics was observed. Dexlansoprazole ODT and dexlansoprazole capsule were both well tolerated
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tu1113 dexlansoprazole modified release Orally Disintegrating Tablet the bioavailability of alternate dosing options
Gastroenterology, 2014Co-Authors: Michael Kukulka, Sai NudurupatiAbstract:Introduction: The proton pump inhibitor dexlansoprazole (DEX) is a modified release (MR) formulation consisting of 2 types of granules within a single capsule. DEX delayed-release capsules are approved for use in adults for treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease, healing of erosive esophagitis (EE), and maintenance of healed EE and relief of heartburn. Because some patients are unable or unwilling to swallow capsules, a DEX MR Orally-Disintegrating (OD) Tablet has been developed. DEX MR OD contains 2 types of granules that release drug in a pH-dependent manner in order to extend DEX plasma concentrations. Objective: To assess the bioavailability (BA) of DEX MR OD 30 mg Tablet swallowed intact with water or mixed with water and administered via nasogastric (NG) tube or oral syringe compared to administration of DEX MR OD 30 mg on the tongue, allowed to disintegrate, and swallowed without water. Methods: This was a phase 1, randomized, single-dose, 4-period crossover study. Qualified healthy subjects 18-55 years old received a single oral dose of 30 mg DEX MR OD as an intact Tablet administered on the tongue, swallowed intact, or mixed with water and administered via oral syringe or NG tube. Each study period was followed by a 5-day washout. Blood samples for determination of plasma pharmacokinetics were collected for 24 hours post-dose in each period. Analyses of variance models were performed, and bioequivalence (BE) between an administration option and DEX MR OD administered on the tongue without water was declared if 90% confidence intervals (CIs) of central value ratios between 2 regimens for maximum plasma concentration (Cmax) and area under the curve (AUC) mean ratios were contained within the BE limits of 0.80-1.25. Safety was assessed via physical examination (PE), clinical laboratory evaluation, vital sign assessment, electrocardiograms (ECG), and adverse event reports (AE). Results: Seventy-seven subjects (mean age 38±9.8 years) were enrolled. The 90% CIs for the BA of DEX MR OD 30 mg administered via oral syringe or NG tube, or swallowed intact, relative to that from administration of DEX MR OD on the tongue without water, for Cmax and AUCs were within the BE range of 0.80-1.25 (TABLE). All 4 regimens were well tolerated. AEs were mild in intensity and were considered not related to study drug. Percentages of subjects experiencing AEs were comparable across the 4 regimens. There were no clinically important findings noted in the PE, safety clinical laboratory, vital sign, or ECG reports. Conclusions: DEX MR OD 30 mg administered as an aqueous mixture via an oral syringe or an NG tube, or as an intact Tablet swallowed with water was each BE to the administration of the DEX MR OD 30 mg on the tongue without water. Single oral doses of DEX MR OD Tablets were well tolerated in this study. Table. BE Assessment of Administration Routes for DEX MR OD Tablets
Julian Howell - One of the best experts on this subject based on the ideXlab platform.
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long term effectiveness and tolerability of sublingual fentanyl Orally Disintegrating Tablet for the treatment of breakthrough cancer pain
Current Medical Research and Opinion, 2011Co-Authors: Srinivas Nalamachu, David Hassman, Mark S Wallace, Sam Dumble, Rob Derrick, Julian HowellAbstract:AbstractBackground and objectives:Breakthrough cancer pain (BTcP) is a transient exacerbation of cancer pain in patients with otherwise stable, persistent background pain. This study evaluated the long-term effectiveness and tolerability of sublingual fentanyl Orally Disintegrating Tablet (sublingual fentanyl ODT), for the treatment of BTcP in opioid-tolerant patients with cancer.Research design and methods:This was a non-randomized, open-label, multi-center, Phase III study conducted in opioid-tolerant patients (aged ≥17 years) with BTcP. The study comprised a 2-week titration phase, followed by a maintenance phase of up to 12 months. Patients self-administered sublingual fentanyl ODT for episodes of BTcP. Effectiveness was assessed using patients’ global evaluation of medication (PGEM), the brief pain inventory (BPI) and the depression, anxiety and positive outlook scale (DAPOS). Adverse events were recorded throughout.Clinical trial registration:NCT00263575 (http://www.clinicaltrials.gov/).Results:Of 1...
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efficacy and long term tolerability of sublingual fentanyl Orally Disintegrating Tablet in the treatment of breakthrough cancer pain
Current Medical Research and Opinion, 2009Co-Authors: Richard L Rauck, Srinivas Nalamachu, David Hassman, Rob Derrick, Marvin Tark, Eva Reyes, Teresa G Hayes, Anthony J Bartkowiak, Julian HowellAbstract:AbstractBackground and objectives:Breakthrough cancer pain (BTcP) represents an important clinical challenge in the care of patients with cancer. This trial evaluated the efficacy and long-term tolerability of a sublingual formulation of the fast-acting opioid fentanyl, for the treatment of BTcP in opioid-tolerant patients with cancer.Research design and methods:This was a randomized, placebo-controlled, multi-center, phase III trial, conducted in opioid-tolerant male and female patients (aged ≥17 years) with BTcP. The study was conducted at 36 centers across the USA. The study comprised a 2-week open-label titration phase, followed by a double-blind efficacy phase, during which patients received sublingual fentanyl citrate Orally Disintegrating Tablet (sublingual fentanyl ODT) or placebo, in a random order. The primary efficacy endpoint was the sum of pain intensity difference (SPID) over 30 min post-administration. Secondary efficacy endpoints included pain intensity difference (PID) and pain relief (PR...
Rani, Karina Citra - One of the best experts on this subject based on the ideXlab platform.
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PREPARATION AND CHARACTERIZATION OF ATENOLOL-β-CYCLODEXTRIN Orally Disintegrating TabletS
'International Journal of Pharmaceutical Sciences and Research', 2019Co-Authors: Rani, Karina Citra, Parfati Nani, Stephanie StephanieAbstract:Atenolol is a hypertension drug that has a low solubility characteristic in water and gastric fluid. The rate of absorption of the drug with poor solubility characteristics is determined by the dissolution process. In this study, an attempt has been conducted to increase the dissolution of atenolol by increasing its solubility. The solubility of atenolol has been enhanced by the inclusion complex using β-cyclodextrin made by several methods (physical mixing, kneading, and solvent evaporation). Evaluation and characterization of atenolol-β-cyclodextrin inclusion complex consist of drug content, dissolution test, Fourier Transformed Infrared analysis (FT-IR), Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD) and Scanning Electron Microscope (SEM). The results of the drug content analysis, dissolution test, and characterization showed that atenolol- β-cyclodextrin inclusion complex, which has been made by the solvent evaporation method was the best approach. Therefore, a solvent evaporation method was chosen to formulate Orally Disintegrating Tablets of atenolol-β-cyclodextrin using direct compression technique. Orally Disintegrating Tablets of atenolol-β-cyclodextrin were prepared using crospovidone as disintegrant. The results of pre-compression test and the post-compression test revealed that Orally Disintegrating Tablets of atenolol-β-cyclodextrin inclusion complex disintegrate within 8.17 ± 0.41 sec. In-vitro dispersion time in simulated saliva was found to be 45.33 ± 0.58 sec and the percentage of atenolol dissolved from this formula was 92.22% in 30 min. Hence, this formula shows good physicochemical characteristics and fulfill pharmaceutical quality requirements of Orally Disintegrating Tablet
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PENGARUH KONSENTRASI SODIUM STARCH GLYCOLATE SEBAGAI SUPERDISINTEGRAN (0% DAN 20%) TERHADAP KARAKTERISTIK FISIK Orally Disintegrating Tablet ATENOLOL
Perpustakaan Universitas Surabaya, 2018Co-Authors: Putri, Jessica Wangsa, Parfati Nani, Rani, Karina CitraAbstract:Abstract - Some geriatric patients have difficulty in swallowing Tablets, resulting non-compliance issues on patient. Respond from the issues, people developed an oral dosage Tablet which easily become soft and rapidly disintegrate in mouth which called Orally Disintegrating Tablet (ODT). Atenolol is one of the anti-hypertension drugs. Atenolol is classified as antagonist selective β1 receptor class that gives the effect of anti-hypertension with low bioavailability, it is necessary to change atenolol dosage forms become ODT to increased absorption of the drug in the body. To accelerate the disintegration time (less than 3 minutes) is used disintegrant sodium starch glycolate with concentration of 0% and 20%. The method that used in the Tablet’s manufacture is a direct compresssion. The result of the ODT evaluation, Tablet dispersion time in vitro, wetting time , water absorption ratio, and dissolution test with its parameters include (AUC, ED and kr) were analysed statistically using one way ANOVA. There a significant difference (α = 0,05) between the formulas that using sodium starch glycolate 0% and 20% in terms of Tablet’s dispersion time in vitro, wetting time, water absorption ratio, dissolution test with its parameters include (AUC, ED and kr). The formula that gives the best result is the one that using 20% disintegran sodium starch glycolate because disintegration time in 19,85±0,95 seconds, Tablet’s dispersion time in vitro 29,00±1,00 seconds, wetting time 23,33±1,53 seconds, water absorption ratio 555±28,45%, TQ% 1,41 minutes, the Q% 90,64±0,44%, AUC 10134,52±29,49% minutes, ED 84,45±0,27%, and kr 0,0056/minutes
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Formulasi Orally Disintegrating Tablet Atenolol β-siklodekstrinmenggunakan Co-process Superdisintegran Crospovidone-Sodium Starch Glycolate
Faculty of Pharmacy University of Surabaya, 2017Co-Authors: Parfati Nani, Rani, Karina Citra, Charles Nathanael, Geovanny Valencia, Paramartha, Dewa Putu PradnyaAbstract:Atenolol-β siklodekstrin sebagai obat anti hipertensi, merupakan rekayasa materi atenolol, yang mempunyai kelarutan kecil. Atenolol-β-siklodekstrin diharapkan mempunyai pelarutan yang besar, sehingga bioavailabilitas meningkat, demikian juga untuk efektivitas terapinya. Orally Disintegrating Tablet adalah bentuk sediaan yang dapat diterima untuk meningkatkan disolusi dengan mempercepat waktu hancur pada media saliva. Karakter Tablet yang cepat hancur dan larut dalam media yang sedikit, hal tersebut aseptabel untuk penderita geriatrik. Co-process superdisintegran crospovidone-sodium starch glycolate memiliki waktu hancur yang sangat cepat, dengan kombinasi mekanisme penetrasi air melalui kapiler dan pengembangan Tablet. Tujuan penelitian ini mempercepat waktu hancur Tablet dengan co-process crospovidone-sodium starch glycolate perbandingan 1:1, 1:2, 1:3. Pembuatan co-process menggunakan metode solvent evaporation. Co-process yang dihasilkan kemudian digunakan dalam formulasi sediaan Orally Disintegrating Tablet atenolol dengan metode cetak langsung. Hasil penelitian Tablet dengan co-process tersebut mempunyai waktu hancur yang cepat, yaitu antara 27,24 detik hingga 60,83 detik, dan formula dengan perbandingan 1:1 yang paling cepat mempunyai waktu hancur rata-rata 27,24 detik. Orally Disintegrating Tablet dengan co-process menghasilkan waktu hancur yang lebih cepat 44% dibandingkan dengan campuran fisikny
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Pengaruh Co-Process Superdisintegran Crospovidone- Croscarmellose Sodium (1:3) pada Sediaan Orally Disintegrating Tablet Atenolol-β-Siklodekstrin
Fakultas Farmasi Universitas Surabaya, 2016Co-Authors: Parfati Nani, Rani, Karina Citra, Saputra, Wayan Gede I ArieAbstract:Orally Disintegrating Tablet (ODT) merupakan bentuk sediaan yang dikembangkan untuk mempercepat waktu hancur, meningkatkan kepatuhan pasien dan efek terapi obat. ODT dirancang memiliki sifat mudah hancur pada rongga mulut kurang dari 1 menit, sehingga geriatri tidak memerlukan tambahan air untuk membantu menelan dan cocok untuk penderita geriatri. Pada penelitian ini dilakukan formulasi sediaan ODT dengan pembentukan kompleks inklusi atenolol-β-siklodekstrin dengan penambahan superdisintegran co-process crospovidone-croscarmellose sodium (1:3) menggunakan metode cetak langsung. Evaluasi pembuatan ODT terdiri dari uji pre-kompresi dan postkompresi. Hasil pembuatan ODT atenolol-β-siklodekstrin juga diuji statistik dari segi waktu pembasahan, rasio penyerapan air, waktu hancur, waktu dispersi in vitro, dan parameter disolusi (AUC,%ED, dan Kr). Penambahan co-process superdisintegran menunjukkan waktu pembasahan 44,45 ± 2,76 detik; rasio penyerapan air 26,27 ± 1,1%; waktu hancur 38,07 ± 4,56 detik; dan waktu dispersi in vitro 73,83 ± 2,71 detik. Hasil Uji disolusi didapatkan nilai AUC 3983,40 ± 189,60; ED 66,39 ± 3,16%; dan Kr 0,0778 ± 0,04. Campuran fisik menunjukkan waktu pembasahan 44,87 ± 3,33 detik; rasio penyerapan air 27,76 ± 1,35%; waktu hancur 38,28 ± 5,32 detik; dan waktu dispersi in vitro 83,20 ± 2,67 detik. Hasil uji disolusi didapatkan nilai AUC 3916,20 ± 235,80; ED 65,27 ± 3,93%; dan Kr 0,0655 ± 0,03. Berdasarkan hasil penelitian yang diperoleh, dapat dilihat bahwa penambahan superdisintegran co-process menunjukkan hasil yang tidak berbeda bermakna dengan campuran fisik
Andrew J. Dowson - One of the best experts on this subject based on the ideXlab platform.
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improved migraine management in primary care results of a patient treatment experience study using zolmitriptan Orally Disintegrating Tablet
International Journal of Clinical Practice, 2006Co-Authors: G Shapero, Andrew J. Dowson, J P Lacoste, Per AlmqvistAbstract:The ‘Zomig Appropriate for Primary care’ programme was developed to address the needs of primary care physicians (PCPs) to improve migraine management. As part of the programme, an international, open-label, 6-month clinical study was performed. The study included new and tangible outcome variables relevant to PCPs and recruited patients presenting in primary care with an established migraine diagnosis. Patients treated up to three migraine attacks per month with zolmitriptan Orally Disintegrating Tablet (ODT) 2.5 mg. All other migraine attacks occurring during the study period were treated with the patient's usual migraine medication (including other triptans). Questionnaires were used to record patient treatment experiences at the study end. The primary end-point was the proportion of patients wanting to continue using zolmitriptan ODT. Some 595 patients treated 7171 migraine attacks with zolmitriptan ODT. Of the 504 patients who completed the 6-month questionnaire, 380 (75.4%) wished to continue using zolmitriptan ODT. The results of the study indicate that patient-orientated end-points are more motivational and meaningful to physicians than traditional end-points used in controlled clinical trials, allowing them to make informed decisions regarding migraine management.
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part iii the convenience of and patient preference for zolmitriptan Orally Disintegrating Tablet
Current Medical Research and Opinion, 2005Co-Authors: Andrew J. Dowson, Per AlmqvistAbstract:ABSTRACTAs part of an optimal strategy for the management of migraine, the individual needs and preferences of patients need to be considered when prescribing treatments. Zolmitriptan has been available as a conventional oral Tablet for more than seven years, and is established as a highly effective, well-tolerated compound for the acute treatment of migraine. A bioequivalent, Orally Disintegrating Tablet (ODT) of zolmitriptan, which dissolves on the tongue without the need for additional fluid intake, has been developed. In a study designed to compare patient preference for zolmitriptan ODT and conventional oral sumatriptan Tablets, > 60% of the 186 patients questioned had an overall preference for zolmitriptan ODT, with > 80% of patients reporting that this was the more convenient and less disruptive therapy to take. Approximately 90% of patients agreed that, unlike a conventional Tablet, zolmitriptan ODT can be taken wherever and whenever a migraine occurs. When patient preference for zolmitriptan ODT ...
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patients with migraine prefer zolmitriptan Orally Disintegrating Tablet to sumatriptan conventional oral Tablet
International Journal of Clinical Practice, 2003Co-Authors: Andrew J. Dowson, B R CharlesworthAbstract:: The Zolmitriptan Evaluation versus Sumatriptan Trial (ZEST) assessed patient preference for 2.5 mg zolmitriptan Orally Disintegrating Tablet (ODT) or 50 mg sumatriptan conventional Tablet in 218 patients with significant migraine disability. Significantly more patients preferred zolmitriptan ODT to sumatriptan conventional Tablet (60.1% vs 39.9%; p = 0.0130). In terms of efficacy, significantly more patients considered zolmitriptan ODT to be an effective migraine treatment than sumatriptan conventional Tablet (77% vs 63%; p = 0.0063). When asked about specific formulation attributes, significantly more patients selected zolmitriptan ODT as the least disruptive therapy (83.6% vs 16.4%), the easiest to take (85.5% vs 14.5%), the most convenient to take (86.1% vs 13.9%), and the one which enabled them to maintain an active lifestyle (65.5% vs 34.5%), compared with the sumatriptan conventional Tablet (all comparisons p < 0.001). Zolmitriptan ODT is a convenient and beneficial alternative to conventional Tablets and is preferred to sumatriptan conventional Tablets by migraineurs.
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zolmitriptan Orally Disintegrating Tablet is effective in the acute treatment of migraine
Cephalalgia, 2002Co-Authors: Andrew J. Dowson, Werner J. Becker, E A Macgregor, R A Purdy, J Green, S L LevyAbstract:A new formulation of zolmitriptan has been developed that dissolves on the tongue without the need for additional fluid intake. In this double-blind, parallel study, 471 patients were randomized to receive the zolmitriptan Orally Disintegrating Tablet 2.5 mg (n=231) or matching placebo (n=240) to treat a single moderate or severe migraine. Headache relief following zolmitriptan 2.5 mg (63%) was significantly greater than with placebo (22%) at 2 h post-dose (primary endpoint; P < 0.0001). The zolmitriptan Orally Disintegrating Tablet was also significantly more effective than placebo for 1-, 2- and 4-h pain-free response (8% vs. 3%, P=0.0207, 27% vs. 7%, P < 0.0001, and 37% vs. 11%, P < 0.0001, respectively). Of those patients stating a preference, 70% of patients preferred the Orally Disintegrating Tablet to a conventional Tablet. Zolmitriptan Orally Disintegrating Tablets are an effective and convenient alternative to a conventional Tablet, allowing migraine attacks to be treated anytime a migraine strikes, which can facilitate earlier treatment.