Zolpidem Tartrate

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C L Bhingare - One of the best experts on this subject based on the ideXlab platform.

  • formulation and evaluation of mouth dissolving films of Zolpidem Tartrate by exploration of polymers combination
    International Journal of Pharmacy, 2013
    Co-Authors: M K Patidar, F A Karjikar, F A Patel, S S Rathi, S B Thokal, C L Bhingare
    Abstract:

    Fast dissolving drug delivery is the new approach to administer drugs; mouth dissolving film is one of them. The object of the present research work was to formulate a mouth dissolving film of Zolpidem Tartrate from polymers Hydroxypropyl cellulose (EF-P) with a combination of Hydroxypropyl methyl cellulose K-15 by solvent casting method for enhancing the drug release rate and absorption to incessant increase drug bioavailability. Hydroxypropyl cellulose is a synthetic water soluble polymer, form a brittle film with high elastic modulus, thus to improve film forming properties, Hydroxypropyl methyl cellulose used in a ration of (1:1 and 2:1) with it. Compatibility of drug and polymers were studied by the IR spectrophotometer, any kind of interaction was not found. All the formulations were evaluated by different evaluation parameters and showed satisfactory results. Batches have uniformity in weight with a thickness of (0.930 mm), (98.3%) drug content and 100% drug release within 6 mins and films pH was reassembled with the pH of saliva. Keyword: Hydroxypropyl methyl cellulose, Hydroxypropyl cellulose, Mouth dissolving film, Solvent Casting Method.

  • formulation and evaluation of mouth dissolving tablet of Zolpidem Tartrate
    International Journal of Pharma Research & Review, 2013
    Co-Authors: S S Mittal, Y N Dholariya, M K Patidar, S B Soni, S A Rathi, C L Bhingare
    Abstract:

    Conventional solid dosage form suffers from problem like difficulty in swallowing with age, onset of action and physiological factor of patient like gastric emptying time. To overcome this mouth dissolving tablet is a newer approach to drug delivery. Zolpidem is preferentially used for the short term treatment of insomnia. The aim of present study is to formulate and evaluate mouth dissolving tablets of Zolpidem Tartrate to improve bioavailability and circumvent the first pass effect. The tablet of Zolpidem was prepared by directing compression method using croscarmellose sodium, sodium starch glycolate as super disintegrant and mannitol, microcrystalline cellulose, dicalcium phosphate as diluents. The effects of different super disintegrants and diluents on disintegration and dissolution time were optimized and on the basis of these parameters, formula was finalized. FTIR study showed compatibility between drug and excipients. The pre-compression study indicated the excellent flow properties of bulk powder which is within an acceptable range of pharmacopoeia specifications. The post compression evaluation parameters results match the expected criteria. From the entire formulations, best in-vitro drug release profile was obtained with the system containing sodium starch glycolate (35mg), mannitol (20mg) and microcrystalline cellulose (60mg). These tablets have a hardness less than 4 kg/cm2, disintegration time of 24 seconds and 97.71% drug release within 30 minutes.

Sandy A. Furey - One of the best experts on this subject based on the ideXlab platform.

Thomas Roth - One of the best experts on this subject based on the ideXlab platform.

  • pharmacokinetics of Zolpidem from sublingual Zolpidem Tartrate tablets in healthy elderly versus non elderly subjects
    Drugs & Aging, 2014
    Co-Authors: David J Greenblatt, Jerold S Harmatz, Thomas Roth, Nikhilesh N Singh, Frank Steinberg, Stephen C Harris, Ram P Kapil
    Abstract:

    Pharmacokinetic parameters of sedative–hypnotic medications can be influenced by age and gender. This study analyzed pharmacokinetic parameters of Zolpidem, formulated as a sublingual Zolpidem Tartrate tablet (ZST; Intermezzo®), in healthy elderly males and females (mean age 72 years) and in non-elderly males and females (34 years). This was a randomized, single-dose, open-label, two-way crossover study evaluating pharmacokinetic parameters of 1.75 and 3.5 mg dosages of ZST in elderly subjects (n = 22), and 3.5 mg dosages of ZST in non-elderly subjects (n = 24). Main outcome measures were pharmacokinetic parameters, including area under the plasma concentration–time curve (AUC), maximum observed concentration (C max), time to reach C max (T max), elimination half-life (T ½), and apparent oral clearance (CL/F). Dose proportionality in Zolpidem exposure was maintained between 1.75 and 3.5 mg doses for both elderly females and males. With administration of the 3.5 mg dose of ZST to elderly and non-elderly subjects, significantly higher systemic exposure was seen in elderly females (C max +44.6 %, P < 0.01; AUC +40.4 %) compared with non-elderly females. However, systemic exposure was only modestly higher in elderly males compared with non-elderly males. Greater exposure was seen in elderly females compared to males (C max +46.8 %, P < 0.01; AUC +31.4 %). In this study, exposure between non-elderly females and males was equivalent. Changes in T ½ and T max values were not observed, with no significant age effect on oral clearance. There were no apparent differences in tolerability among age and gender groups. Elderly individuals were found to have higher C max and AUC values compared with non-elderly subjects. C max and AUC were greater in elderly women compared with elderly men.

  • gender influences on efficacy and safety of sublingual Zolpidem Tartrate for middle of the night awakening in insomnia
    Human Psychopharmacology-clinical and Experimental, 2014
    Co-Authors: Thomas Roth, Nikhilesh N Singh, Frank Steinberg, M Moline
    Abstract:

    Objective Evaluate potential gender effects on efficacy and safety of a buffered Zolpidem sublingual tablet (ZST) formulation. Methods Post hoc analysis of the pivotal sleep laboratory and outpatient studies, per gender. Results In the sleep laboratory study, polysomnography-derived latency to persistent sleep after middle-of-the-night was significantly improved for both genders at both 1.75 mg and 3.5 mg ZST (females: 15.7 and 8.6 min, respectively, vs. 27.7 min [placebo]; males: 19.0 and 12.7 min vs. 29.0 min [placebo]) with no significant gender differences. In the outpatient study, subjective sleep onset latency after middle-of-the-night was significantly shorter for both genders treated with ZST 3.5 mg versus placebo over the 4-week average (females: 37.3 vs. 59.4 min, p < 0.0001; males: 38.6 vs. 55.1 min, p ≤ 0.01). There were no gender differences in subjective sleep onset latency after middle-of-the-night awakening. In the outpatient study, weekly usage of ZST and placebo by both genders declined throughout the study. Morning alertness following dosing nights improved in both genders, although significant only in females. In both studies, there were no gender differences in adverse events. Conclusion(s) Time to return to sleep after middle-of-the-night dosing with ZST improved in both genders, with no gender differences in efficacy and safety. Copyright © 2013 John Wiley & Sons, Ltd.

  • influence of food on pharmacokinetics of Zolpidem from fast dissolving sublingual Zolpidem Tartrate tablets
    The Journal of Clinical Pharmacology, 2013
    Co-Authors: David J Greenblatt, Jerold S Harmatz, Thomas Roth, Nikhilesh N Singh, Stephen C Harris, Ram P Kapil
    Abstract:

    Ingesting food can impact the pharmacokinetics of sedative-hypnotic drugs. A buffered Zolpidem sublingual tablet (ZST) recently became available for the treatment of middle-of-the-night awakening. In this randomized, open-label, single-site study, the pharmacokinetic profile of ZST was evaluated when administered while fasting and following a standard high-fat meal (fed state). Healthy adults aged 18-64 years received a single morning dose of 3.5 mg ZST in the fed or fasting state. From 20 min to 3 h post-dose, Zolpidem plasma levels were lower in the fed state compared to the fasting state. After 4 h post-dose (corresponding to "morning wake time"), higher Zolpidem plasma levels were evident in the fed state. Area under the concentration-time curve (AUC) values for the 0-8 h interval were 160 ng/mL h in the fed state and 203 ng/mL h in the fasting state (P < .001). In the fed versus fasting states, Cmax was 32.0 ng/mL versus 57.3 ng/mL (P < .001), respectively, and Tmax was 3.0 h versus 0.92 h (P < .001), respectively. Together these data suggest that administration of ZST in the fed state is not optimal for maximizing the likelihood of therapeutic benefit and minimizing the probability of residual sedation.

  • sex differences in middle of the night efficacy of Zolpidem Tartrate sublingual tablets in a 4 week insomnia outpatient trial p05 013
    Neurology, 2013
    Co-Authors: Thomas Roth, Nikhilesh N Singh, Frank Steinberg, M Moline
    Abstract:

    OBJECTIVE: Assess possible sex differences on latency to sleep onset (LSO) and tolerability of 3.5mg Zolpidem Tartrate sublingual tablets (ZST) in patients whose insomnia is characterized by difficulty returning to sleep after middle-of-the-night (MOTN) awakenings. BACKGROUND: ZST is indicated for as-needed use after appropriate MOTN awakenings. Across sexes, ZST decreased LSO over 4 weeks (baseline 68.1 min; ZST 38.2 min) compared with placebo (baseline 69.4 min; placebo 56.4 min; (P DESIGN/METHODS: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, 201 females/94 males (median 43 years), with primary insomnia characterized by difficulty returning to sleep after MOTN awakenings (≥3 MOTN awakenings/week during screening). New analyses evaluated effects of sex and treatment*sex interactions. After 2-week placebo screening, subjects were randomized to as-needed MOTN dosing with 3.5mg ZST or placebo for 4 weeks. An IVRS determined if study drug could be taken and collected efficacy measures. RESULTS: ZST significantly decreased LSO compared with placebo in females (ZST: baseline 68.6 min; treatment 37.3 min; placebo: baseline 72.6 min; treatment 59.4 min; p CONCLUSIONS: 3.5mg ZST used prn significantly reduced LSO compared to placebo in both female and male insomnia patients. Postdosing wake time was less, and morning sleepiness/alertness scores improved. ZST was well tolerated in both sexes. Supported by: Transcept Pharmaceuticals, Inc. Post-study support was also provided by Purdue Pharma L.P. Disclosure: Dr. Roth has received personal compensation for activities with Abbott, Accadia, AstraZeneca, Aventis, AVER, Bayer, Bristol-Myers Squibb Company, Cypress, GlaxoSmithKline, Inc., Impax, Intec, Jazz, Johnson & Johnson, Merck, Neurocrine, Novartis, Proctor and Gamble, Pfizer Inc, Purdue Pharma, Shire, Somaxon, and TransOral. Dr. Roth has received research support from Cephalon/Teva Neuroscience and Merck. Dr. Steinberg has received personal compensation for activities with Transcept Pharmaceuticals as a consultant. Dr. Steinberg holds stock and/or stock options in Transcept Pharmaceuticals. Dr. Singh has received personal compensation for activities with Transcept Pharmaceuticals as an employee. Dr. Singh holds stock and/or stock options in Transcept Pharmaceuticals. Dr. Moline has received personal compensation for activities with Purdue Pharma, LP.

  • novel sublingual low dose Zolpidem tablet reduces latency to sleep onset following spontaneous middle of the night awakening in insomnia in a randomized double blind placebo controlled outpatient study
    Sleep, 2013
    Co-Authors: Thomas Roth, Nikhilesh N Singh, Frank Steinberg, Andrew D Krystal, M Moline
    Abstract:

    STUDY OBJECTIVES To evaluate efficacy and safety of 3.5-mg Zolpidem Tartrate sublingual tablets (ZST) on latency to sleep onset after middle-of-the-night (MOTN) awakenings in patients with insomnia characterized by difficulty returning to sleep after MOTN awakenings. DESIGN Multicenter randomized, double-blind, placebo-controlled, parallel-group. SETTING Outpatient. PATIENTS There were 295 adults (median age 43 y; 68.1% female) with primary insomnia and difficulty returning to sleep after MOTN awakenings (three or more MOTN awakenings/wk during screening). INTERVENTIONS After a 2-wk, single-blind placebo eligibility period, participants were randomized 1:1 to as-needed MOTN dosing with 3.5 mg ZST or placebo for 28 nights. An interactive voice response system determined if the study drug could be taken and recorded sleep/wake efficacy measures. RESULTS ZST significantly (P < 0.0001) decreased latency to sleep onset over 4 wk (baseline 68.1 min; ZST 38.2 min) compared with placebo (baseline 69.4 min; placebo 56.4 min). Ratings of morning sleepiness/alertness significantly (P = 0.0041) favored the ZST group on nights medication was taken but not on other nights. Participants in the ZST group took the study drug on 62% of nights during the 4 wk; members of the placebo group took study medication on 64% of nights. Adverse events were generally mild and at the same rate (19.3% of participants) in both groups. There were no treatment-related serious adverse events (SAEs), and one adverse event-related study discontinuation from the placebo group. Dosing/week did not increase across the study. CONCLUSIONS 3.5 mg ZST used as needed significantly reduced latency to return to sleep in comparison with placebo in these patients with insomnia. Sleep quality was improved, and morning sleepiness/alertness scores also improved. ZST was well tolerated. These data demonstrate the utility of a sleep-promoting agent when used as needed in the MOTN. CLINICAL TRIAL INFORMATION CLINICAL TRIALS REGISTRATION NCT00466193: "A Study of Zolpidem Tartrate Tablet in Adult Patients with Insomnia" http://www.clinicaltrials.gov/ct2/show/NCT00466193?spons=%22Transcept+Pharmaceuticals%22&spons_ex=Y&rank=2

M Moline - One of the best experts on this subject based on the ideXlab platform.

  • gender influences on efficacy and safety of sublingual Zolpidem Tartrate for middle of the night awakening in insomnia
    Human Psychopharmacology-clinical and Experimental, 2014
    Co-Authors: Thomas Roth, Nikhilesh N Singh, Frank Steinberg, M Moline
    Abstract:

    Objective Evaluate potential gender effects on efficacy and safety of a buffered Zolpidem sublingual tablet (ZST) formulation. Methods Post hoc analysis of the pivotal sleep laboratory and outpatient studies, per gender. Results In the sleep laboratory study, polysomnography-derived latency to persistent sleep after middle-of-the-night was significantly improved for both genders at both 1.75 mg and 3.5 mg ZST (females: 15.7 and 8.6 min, respectively, vs. 27.7 min [placebo]; males: 19.0 and 12.7 min vs. 29.0 min [placebo]) with no significant gender differences. In the outpatient study, subjective sleep onset latency after middle-of-the-night was significantly shorter for both genders treated with ZST 3.5 mg versus placebo over the 4-week average (females: 37.3 vs. 59.4 min, p < 0.0001; males: 38.6 vs. 55.1 min, p ≤ 0.01). There were no gender differences in subjective sleep onset latency after middle-of-the-night awakening. In the outpatient study, weekly usage of ZST and placebo by both genders declined throughout the study. Morning alertness following dosing nights improved in both genders, although significant only in females. In both studies, there were no gender differences in adverse events. Conclusion(s) Time to return to sleep after middle-of-the-night dosing with ZST improved in both genders, with no gender differences in efficacy and safety. Copyright © 2013 John Wiley & Sons, Ltd.

  • sex differences in middle of the night efficacy of Zolpidem Tartrate sublingual tablets in a 4 week insomnia outpatient trial p05 013
    Neurology, 2013
    Co-Authors: Thomas Roth, Nikhilesh N Singh, Frank Steinberg, M Moline
    Abstract:

    OBJECTIVE: Assess possible sex differences on latency to sleep onset (LSO) and tolerability of 3.5mg Zolpidem Tartrate sublingual tablets (ZST) in patients whose insomnia is characterized by difficulty returning to sleep after middle-of-the-night (MOTN) awakenings. BACKGROUND: ZST is indicated for as-needed use after appropriate MOTN awakenings. Across sexes, ZST decreased LSO over 4 weeks (baseline 68.1 min; ZST 38.2 min) compared with placebo (baseline 69.4 min; placebo 56.4 min; (P DESIGN/METHODS: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, 201 females/94 males (median 43 years), with primary insomnia characterized by difficulty returning to sleep after MOTN awakenings (≥3 MOTN awakenings/week during screening). New analyses evaluated effects of sex and treatment*sex interactions. After 2-week placebo screening, subjects were randomized to as-needed MOTN dosing with 3.5mg ZST or placebo for 4 weeks. An IVRS determined if study drug could be taken and collected efficacy measures. RESULTS: ZST significantly decreased LSO compared with placebo in females (ZST: baseline 68.6 min; treatment 37.3 min; placebo: baseline 72.6 min; treatment 59.4 min; p CONCLUSIONS: 3.5mg ZST used prn significantly reduced LSO compared to placebo in both female and male insomnia patients. Postdosing wake time was less, and morning sleepiness/alertness scores improved. ZST was well tolerated in both sexes. Supported by: Transcept Pharmaceuticals, Inc. Post-study support was also provided by Purdue Pharma L.P. Disclosure: Dr. Roth has received personal compensation for activities with Abbott, Accadia, AstraZeneca, Aventis, AVER, Bayer, Bristol-Myers Squibb Company, Cypress, GlaxoSmithKline, Inc., Impax, Intec, Jazz, Johnson & Johnson, Merck, Neurocrine, Novartis, Proctor and Gamble, Pfizer Inc, Purdue Pharma, Shire, Somaxon, and TransOral. Dr. Roth has received research support from Cephalon/Teva Neuroscience and Merck. Dr. Steinberg has received personal compensation for activities with Transcept Pharmaceuticals as a consultant. Dr. Steinberg holds stock and/or stock options in Transcept Pharmaceuticals. Dr. Singh has received personal compensation for activities with Transcept Pharmaceuticals as an employee. Dr. Singh holds stock and/or stock options in Transcept Pharmaceuticals. Dr. Moline has received personal compensation for activities with Purdue Pharma, LP.

  • novel sublingual low dose Zolpidem tablet reduces latency to sleep onset following spontaneous middle of the night awakening in insomnia in a randomized double blind placebo controlled outpatient study
    Sleep, 2013
    Co-Authors: Thomas Roth, Nikhilesh N Singh, Frank Steinberg, Andrew D Krystal, M Moline
    Abstract:

    STUDY OBJECTIVES To evaluate efficacy and safety of 3.5-mg Zolpidem Tartrate sublingual tablets (ZST) on latency to sleep onset after middle-of-the-night (MOTN) awakenings in patients with insomnia characterized by difficulty returning to sleep after MOTN awakenings. DESIGN Multicenter randomized, double-blind, placebo-controlled, parallel-group. SETTING Outpatient. PATIENTS There were 295 adults (median age 43 y; 68.1% female) with primary insomnia and difficulty returning to sleep after MOTN awakenings (three or more MOTN awakenings/wk during screening). INTERVENTIONS After a 2-wk, single-blind placebo eligibility period, participants were randomized 1:1 to as-needed MOTN dosing with 3.5 mg ZST or placebo for 28 nights. An interactive voice response system determined if the study drug could be taken and recorded sleep/wake efficacy measures. RESULTS ZST significantly (P < 0.0001) decreased latency to sleep onset over 4 wk (baseline 68.1 min; ZST 38.2 min) compared with placebo (baseline 69.4 min; placebo 56.4 min). Ratings of morning sleepiness/alertness significantly (P = 0.0041) favored the ZST group on nights medication was taken but not on other nights. Participants in the ZST group took the study drug on 62% of nights during the 4 wk; members of the placebo group took study medication on 64% of nights. Adverse events were generally mild and at the same rate (19.3% of participants) in both groups. There were no treatment-related serious adverse events (SAEs), and one adverse event-related study discontinuation from the placebo group. Dosing/week did not increase across the study. CONCLUSIONS 3.5 mg ZST used as needed significantly reduced latency to return to sleep in comparison with placebo in these patients with insomnia. Sleep quality was improved, and morning sleepiness/alertness scores also improved. ZST was well tolerated. These data demonstrate the utility of a sleep-promoting agent when used as needed in the MOTN. CLINICAL TRIAL INFORMATION CLINICAL TRIALS REGISTRATION NCT00466193: "A Study of Zolpidem Tartrate Tablet in Adult Patients with Insomnia" http://www.clinicaltrials.gov/ct2/show/NCT00466193?spons=%22Transcept+Pharmaceuticals%22&spons_ex=Y&rank=2

M K Patidar - One of the best experts on this subject based on the ideXlab platform.

  • formulation and evaluation of mouth dissolving films of Zolpidem Tartrate by exploration of polymers combination
    International Journal of Pharmacy, 2013
    Co-Authors: M K Patidar, F A Karjikar, F A Patel, S S Rathi, S B Thokal, C L Bhingare
    Abstract:

    Fast dissolving drug delivery is the new approach to administer drugs; mouth dissolving film is one of them. The object of the present research work was to formulate a mouth dissolving film of Zolpidem Tartrate from polymers Hydroxypropyl cellulose (EF-P) with a combination of Hydroxypropyl methyl cellulose K-15 by solvent casting method for enhancing the drug release rate and absorption to incessant increase drug bioavailability. Hydroxypropyl cellulose is a synthetic water soluble polymer, form a brittle film with high elastic modulus, thus to improve film forming properties, Hydroxypropyl methyl cellulose used in a ration of (1:1 and 2:1) with it. Compatibility of drug and polymers were studied by the IR spectrophotometer, any kind of interaction was not found. All the formulations were evaluated by different evaluation parameters and showed satisfactory results. Batches have uniformity in weight with a thickness of (0.930 mm), (98.3%) drug content and 100% drug release within 6 mins and films pH was reassembled with the pH of saliva. Keyword: Hydroxypropyl methyl cellulose, Hydroxypropyl cellulose, Mouth dissolving film, Solvent Casting Method.

  • formulation and evaluation of mouth dissolving tablet of Zolpidem Tartrate
    International Journal of Pharma Research & Review, 2013
    Co-Authors: S S Mittal, Y N Dholariya, M K Patidar, S B Soni, S A Rathi, C L Bhingare
    Abstract:

    Conventional solid dosage form suffers from problem like difficulty in swallowing with age, onset of action and physiological factor of patient like gastric emptying time. To overcome this mouth dissolving tablet is a newer approach to drug delivery. Zolpidem is preferentially used for the short term treatment of insomnia. The aim of present study is to formulate and evaluate mouth dissolving tablets of Zolpidem Tartrate to improve bioavailability and circumvent the first pass effect. The tablet of Zolpidem was prepared by directing compression method using croscarmellose sodium, sodium starch glycolate as super disintegrant and mannitol, microcrystalline cellulose, dicalcium phosphate as diluents. The effects of different super disintegrants and diluents on disintegration and dissolution time were optimized and on the basis of these parameters, formula was finalized. FTIR study showed compatibility between drug and excipients. The pre-compression study indicated the excellent flow properties of bulk powder which is within an acceptable range of pharmacopoeia specifications. The post compression evaluation parameters results match the expected criteria. From the entire formulations, best in-vitro drug release profile was obtained with the system containing sodium starch glycolate (35mg), mannitol (20mg) and microcrystalline cellulose (60mg). These tablets have a hardness less than 4 kg/cm2, disintegration time of 24 seconds and 97.71% drug release within 30 minutes.

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