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Background: An immediate-release, multiparticulate capsule formulation of tizanidine has been developed to modify tizanidine pharmacokinetic characteristics in an attempt to decrease adverse events (AEs) while maintaining effectiveness in the management of spasticity.

Objective: This study was designed to compare the pharmacokinetic properties and tolerability of a single dose (4 mg) of an immediate-release, multiparticulate tizanidine capsule versus a commercially available tablet (reference) administered after a standardized high-fat meal.

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Methods: This single-dose, randomized, open-label, 2-way crossover study in healthy, nonsmoking adult subjects was conducted at MDS Pharma Services, Belfast, United Kingdom. Subjects were randomly assigned to receive the capsule-tablet or tablet-capsule treatment. The 2 treatment periods were separated by a 6-day washout period. All treatments were administered after a standardized high-fat meal. To determine plasma tizanidine pharmacokinetic properties, blood samples were collected over 24 hours after administration. The predetermined bioequivalence range for the test drug (capsule) was 80% to 125% of the reference drug (tablet). Drug tolerability was assessed using routine physical examination, including vital-sign measurements; laboratory analysis (hematology, biochemistry, and urinalysis); 12-lead electrocardiography; direct observation; spontaneous reporting; and non specific questioning.

Results: This study included 18 subjects (12 men, 6 women; mean [SD] age, 26 [7] years). The mean height and body weight of the subjects were 176 (8) cm and 70.1 (9.6) kg, respectively. The peak exposure, as measured by mean natural logarithm-transformed C(max) values, was significantly lower with the capsule compared with the tablet (2.7 vs 4.0 ng/mL; P < 0.019), and mean TmaX was significantly longer (2.6 vs 1.2 hours; P < 0.001). The 90% CIs for the capsule:tablet treatment ratios were 70.55 to 121.94 for AUC(0-lat) and 70.12 to 118.75 for AUC(0-infinity). The capsule did not achieve the protocol-defined definition of bioequivalence when given after a high-fat meal. All AEs were transient and mild in intensity, with asthenia being the most common event with the capsule and tablet formulations, occurring in 5 (28%) and 8 (44%) subjects, respectively.

Conclusions: In this small study in healthy volunteers, after a single oral dose was administered following a high-fat meal, the mean C(max) was significantly lower and mean T(max) was significantly longer with the capsule formulation of tizanidine compared with the tablet. The capsule formulation was found not to be bioequivalent to the tablet when given with food. Based on these findings, caution is needed when a patient is switched between the capsule and tablet formulations of tizanidine, or when the timing of administration of either formulation is changed in relation to food ingestion.

Other tablets come in chewable forms, or as orally dissolving tablets (ODT), which break down on their own in saliva. These types of tablets can be especially helpful for people who have trouble swallowing.

In every case, the dissolved tablet medication is eventually absorbed into your bloodstream. The dissolved medication travels to your liver and is then distributed to one or more target areas in your body so that it can do its job.

Tablets have a longer shelf life and come in a variety of forms. They can also accommodate a higher dose of an active ingredient than a capsule. They tend to be slower acting and, in some cases, may disintegrate unevenly in your body.

If you have allergies to certain pill additives, need a vegan option, or have a hard time swallowing pills, be sure to tell your doctor. They can work with you to find the best type of tablet or capsule for your needs.

Methods: In this prospective interventional study, patients were evaluated from June to November 2016 at DM clinics affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. Adult patients with Type 2 DM who were eligible for inclusion criteria switched from metformin tablet to metformin capsule. Hemoglobin A1c (HbA1c), GI side effects, and patient satisfaction based on visual analog scale (VAS) were assessed during a 6-week follow-up of receiving metformin capsule.

Findings: One hundred and three patients were evaluated, and 75 patients participated in this study. At the baseline, 40 patients (53.3%) had GI side effects due to metformin tablet which was reduced to 16 patients (21.3%) after switching to metformin capsule (P = 0.001). There was also an improvement in HbA1c (from 7 to 6.8,P < 0.0001). The results of patients' satisfaction based on VAS and numeric rating scale indicated that in 59 patients (78.67%), GI side effects were reduced after switching to metformin capsule (mean score: 7.2 with the range of 6-9) while 16 patients stated no treatment preference.

Cellcept (Roche Pharmaceuticals Corporation, Basel, Switzerland) is the original formulation of MMF. My-Rept (Chong Kun Dang Pharmaceutical Corporation, Seoul, Korea) is a generic form of MMF that was approved by the Korean Ministry of Food and Drug Administration (KFDA) in 2008 (for capsule form) and 2010 (for tablet form). The pharmacokinetic profile of an MMF generic formulation (My-Rept tablet and My-Rept capsule) is equivalent to those of Cellcept.3,4

Patients may have a harder time swallowing a capsule than a tablet because the floating property of the capsule makes it lighter than water, causing an uneasy globus sensation. In contrast, tablets are typically heavier than water, which could minimize the uneasy feeling in the oral cavity when swallowing.9 Thus, the tablet formulation may help alleviate patient discomfort, leading to increased compliance, better quality of life, and possibly better efficacy. Tablets undergo a more efficient and scalable manufacturing process than that used for capsule manufacture and are considered a preferred pharmaceutical dosing formulation for higher unit volume commercial production. A 500-mg tablet form of generic MMF (My-Rept), produced by Chong Kun Dang Pharmaceutical Corporation, was approved by the KFDA in 2010.4 Therefore, a bioequivalence investigation should be performed to characterize exposure to the tablet formulation relative to the current marketed capsule formulation.

In this prospective, randomized study, we investigated the efficacy and safety of different forms (tablet or capsule) of generic MMF in LT recipients. The present study showed a similar incidence of BPAR: 6.7% in the tablet group vs 6.1% in the capsule group. No patients in the PP population developed graft failure or died. The incidence of efficacy failure was not significantly different according to the form of MMF. In addition, the new tablet form of MMF with basiliximab induction, tacrolimus, and corticosteroids appeared to be efficacious for preventing acute rejection or graft failure.

MMF has been widely used to improve the renal function commonly associated with CNI.1 The dose of MMF and trough level of MPA in both groups were similar at post-transplant. We tapered the MMF dose of 500 mg/day at the post-transplant 24 weeks because of the possibility of rejection and/or AEs. Serum creatinine and eGFR levels were not different between the two groups at regular visits. Therefore, the tablet formation is not likely to affect renal function. Data on the optimal dose of MMF in combination with tacrolimus are scarce. Moreover, no studies have compared the different forms of MMF in LT recipients, especially in the Asian population. The costs of MMF in the commercial market in Korea are as follows: Cellcept 250-mg capsules, US $0.8; My-Rept 250-mg capsules, US $0.7; and My-Rept 500-mg tablets, US $1.1 (all values were converted using the 2018 exchange rate). The costs for a 1,000 mg dose according to dosage form are as follows: Cellcept 250-mg capsules, US $3.2; My-rept 250-mg capsules, US $2.9; and My-rept 500-mg tablets, US $2.2. When we consider MMF usage during the long-term period, My-Rept tablet is cheaper than My-Rept capsule or Cellcept. Therefore, the present study suggests that the tablet form of MMF (500 mg) may be more convenient in terms of drug ingestion and more cost-effective than the capsule form (250 mg) for LT recipients. The rates of reported SAE were similar (7.2% in the tablet group vs 7.6% in the capsule group). The formulations appeared to be equally well tolerated by liver transplantation recipients. SAEs were not treatment-related drugs. In addition, no clinically relevant differences in overall safety profiles of the two formulations were evident.

Mycophenolate mofetil oral dosage forms (capsules, tablets or oral suspension) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of mycophenolate mofetil oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent.

Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules and oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water.

The type and frequency of adverse events in a clinical study for prevention of kidney allograft rejection in 100 pediatric patients 3 months to 18 years of age dosed with mycophenolate mofetil for oral suspension 600 mg/m2 twice daily (up to 1 g twice daily) were generally similar to those observed in adult patients dosed with mycophenolate mofetil capsules at a dose of 1 g twice daily with the exception of abdominal pain, fever, infection, pain, sepsis, diarrhea, vomiting, pharyngitis, respiratory tract infection, hypertension, leukopenia, and anemia, which were observed in a higher proportion in pediatric patients. 2351a5e196