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At least 1,441 records · Page 80Linked to original sources
PubMed2001

Predictive ability of level A in vitro-in vivo correlation for ringcap controlled-release acetaminophen tablets.

PURPOSE: The goal of this study was to establish and validate an in vitro-in vivo correlation (IVIVC) for two sustained-release formulations (i.e., a matrix tablet and a RingCap banded matrix tablet) containing 750 mg of acetaminophen. METHODS: The in vitro dissolution and in vivo disposition of these formulations were examined by using a USP type III dissolution apparatus and a single-dose, three-way, crossover study that included an immediate-release acetaminophen dosage form, respectively. An IVIVC was established by using the mean fraction dissolved (FD) and mean fraction absorbed (FA) and used to simulate the plasma concentration-time profile of acetaminophen after administration of the matrix tablet (i.e., internal validation) and RingCap banded matrix tablet (i.e., external validation). RESULTS: A statistically significant relationship (r2 = 0.997, P < 0.001) existed between the FD and FA for matrix tablets and was best described by the equation (FA) = 0.984 x (FD) + 0.0133. The percent predictions errors in CMAX and AUCL were <10% when predicting the plasma concentration-time profiles for the two formulations, validating the internal and external predictability of the IVIVC. CONCLUSIONS: The data (i) show that in vitro dissolution data are a good predictor of in vivo fraction absorbed for acetaminophen, (ii) support the general use of in vitro dissolution data for readily soluble and readily absorbed drugs, (iii) suggest that acetaminophen may serve as a model drug for evaluating novel sustained-release delivery systems, and (iv) provide a tangible example of the limitations of current methods for predicting and validating IVIVC.

Acetaminophen↗
PubMed1990

Formulation and in vitro-in vivo evaluation of sustained-release lithium carbonate tablets.

The release of lithium carbonate incorporated into polymethylmethacrylate, polyvinyl chloride, hydrogenated vegetable oil, and carbomer matrix tablets was studied in vitro. The formulation containing 10% carbomer showed a sustained-release profile comparable to that of a standard, commercially available, sustained-release preparation containing 400 mg lithium carbonate embedded in a composite material. In vivo the newly formulated and standard sustained-release lithium carbonate tablets were compared to an oral solution and conventional lithium carbonate tablets in 12 healthy subjects. These crossover studies showed that the sustained-release tablets produced a flatter serum concentration curve than the oral solution and conventional tablet, without loss of total bioavailability.

Adult↗
PubMed1996

Excipient interaction with cetylpyridinium chloride activity in tablet based lozenges.

PURPOSE: The purpose of the investigation was to determine the effect of tablet excipients on the activity of cetylpyridinium chloride (CPC) and the relative interaction between excipients and CPC. METHODS: An analytical assay was developed to evaluate the interaction between CPC and the excipients. In vivo activity was investigated using six volunteers by determining the reduction in colony forming units recoverable from the oropharynx after sucking each proprietary lozenge separately on different days. In vitro determinations investigated the relative antimicrobial activity of aqueous solutions of the lozenges and, the effect of pH and tablet base excipients on that activity against Staphylococcus aureus, Streptococcus pyogenes and Candida albicans. RESULTS: Both in vivo and in vitro results showed that the tablet based lozenges had markedly reduced antimicrobial activities compared with previous results with a candy based lozenge (in vivo and in vitro) or the same concentration of aqueous CPC (in vitro). Magnesium stearate suspensions in CPC 250 micrograms/ml indicated that magnesium stearate adsorbed CPC and at 0.4% lozenge weight and above significantly reduced the antimicrobial activity of CPC 250 micrograms/ml. CONCLUSIONS: The reduced activity of CPC in tablet based lozenges resulted from a decreased availability of CPC in solution due to an adsorption of CPC on magnesium stearate. To avoid this reduction in activity tablet based lozenges containing CPC 250 micrograms/ml, or similar concentrations, plus magnesium stearate should contain not more than 0.3% w/w lozenge weight of the lubricant.

Administration, Oral↗
PubMed1987

Correlation of ibuprofen bioavailability with gastrointestinal transit by scintigraphic monitoring of 171Er-labeled sustained-release tablets.

External gamma scintigraphy was used to monitor the gastrointestinal (GI) transit of radiolabeled sustained-release tablets containing 800 mg ibuprofen in eight fasted healthy volunteers. Ibuprofen serum concentrations were determined from blood samples drawn sequentially over a 24-hr period. Serum concentrations and related parameters were correlated to the position of the dosage form in the GI tract from the scintiphotos. The sustained-release tablets were radiolabeled intact utilizing a neutron activation procedure, by incorporating 0.18% of 170Er2O3 (enriched to greater than 96% 170Er) into the bulk formulation. After manufacture of the final dosage forms, the tablets were irradiated in a neutron flux (4.4 x 10(13) n/cm2.sec) for 2 min, converting the stable 170Er to radioactive 171Er (t1/2 = 7.5 hr). Each tablet contained 50 microCi of 171Er at the time of administration. The scintigraphy studies suggested that the greatest proportion of ibuprofen was absorbed from this dosage form while the tablet was in the large bowel. The dosage forms eroded slowly in the small bowel and appeared to lose their integrity in the large bowel. In vitro studies showed only minimal effects of the neutron irradiation procedure on the dosage form performance.

Biological Availability↗
PubMed1988

Use of a pharmacologic indicator to compare compliance with tablets prescribed to be taken once, twice, or three times daily.

By use of an interview, return tablet count, and a pharmacologic indicator (low-dose phenobarbital), we compared compliance with tablets prescribed to be taken once, twice, or three times daily. One hundred seventy-nine patients with type II diabetes were randomly allocated to take one 2 mg phenobarbital tablet once, twice, or three times daily for 28 days. Phenobarbital level/dose ratios indicated that compliance was similar with once- and twice-daily regimens, and both were better than thrice-daily dosing. Mean return tablet counts suggested that compliance was best with the once-daily regimen; both twice- and thrice-daily regimens were similarly inferior. This difference between the techniques may be explained by the inadequacies of the residual tablet count, which identified only 13% of cases identified by phenobarbital. We conclude that compliance with the once-daily regimen was best, but that compliance with a twice-daily regimen was very similar, and both were superior to dosing three times a day.

Drug Administration Schedule↗
PubMed2003

Evaluation of the quality of amodiaquine and sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania.

OBJECTIVE: There are several independent reports in Tanzania of treatment failures with commercially available sulphadoxine/pyrimethamine (SP) and amodiaquine (AQ) brands. The aim of this work was to assess the quality of SP and AQ tablets marketed by wholesale pharmacies in Dar Es Salaam, Tanzania. METHODS: All eight wholesale pharmacies authorized to import medicines and located in Dar Es Salaam were included in the study. From each pharmacy, samples of all SP and AQ brands available at the time of sampling were bought, provided they had a shelf-life of at least 1 year. A sample was either an intact box of 100 tablets or a sealed tin of 100 tablets. To ensure blinding, 30 tablets of each sample were removed from their original containers, coded and sent to the quality control laboratory for analysis. The name, strength, batch number, manufacturer and the expiry dates of the tablets were recorded. In total 15 AQ and 18 SP samples were collected. Identity, assay for content of active ingredients and dissolution assay were performed as described in the United States Pharmacopoeia (USP). RESULTS: All samples passed the identity test. Among the AQ samples collected, two of 15 (13%) failed the dissolution test but all passed the assay for content, whereas two of 18 (11%) and eight of 18 (44%) SP samples failed the assay for content and dissolution tests, respectively. None of the pharmacies stocked all AQ and SP brands. CONCLUSION: This work reveals the availability of poor quality antimalarial drugs on the Tanzanian market. Use of substandard drugs could have serious clinical consequences to patients. The results support the need for continuous monitoring of the quality of marketed drugs to ensure safety and efficacy of these products in the treatment of malaria in endemic areas.

Amodiaquine↗
PubMed2005

Development and mathematical simulation of theophylline pulsatile release tablets.

Theophylline pulsatile release tablets consisting of a fast-swelling core with a water-insoluble ethylcellulose were developed. Effects of coating material, the amount of the plasticizer, subcoating, the type of the disintegrant, and coating level on the release profiles were investigated. Results showed that ethylcellulose was the best candidate polymer for pulsatile release tablets. Rupture time increased with increasing the amount of the plasticizer, but 15% plasticizer provided the best release profiles. Tablets with Methocel E50 as subcoating was most optimal in order to achieve a long lag time and followed by a rapid release. The lag time of tablets containing different disintegrants increased in the following order: croscarmellose (Ac-Di-Sol) < sodium starch glycolate (Explotab) < low-substituted hydroxypropyl cellulose (L-HPC) < crospovidone (Kollidon CL). And the rupture time increased with higher coating level. A mathematical model was presented to predict the lag time prior to rupture. Results of the water uptake experiment were used to estimate the apparent diffusion coefficient of the coating tablets. The prediction of the lag time based on the presented model is in good agreement with the experimental results.

Absorption↗
PubMed2002

Influence of hydroxypropyl methylcellulose mixture, apparent viscosity, and tablet hardness on drug release using a 2(3) full factorial design.

This study investigates the effects of three factors: (1) use of a mixture of two different grades of hydroxypropyl methylcellulose (HPMC), (2) apparent viscosity, and (3) tablet hardness on drug release profiles of extended-release matrix tablets. The lot-to-lot apparent viscosity difference of HPMC K15M on in vitro dissolution was also investigated. Four test formulations were made, each containing 10% of a very water-soluble active pharmaceutical ingredient (API), 32% HPMC K15M, or a mixture of HPMC K100LV and HPMC K100M, 56% diluents, and 2% lubricants. Each formulation was made at two hardness levels. A 2(3) full factorial design was used to study various combinations of the three factors using eight experiments conducted in a randomized order. Dissolution studies were performed in USP apparatus I. The values of t50% (time in which 50% drug is released) and tlag (lag time, the time taken by the matrix tablet edges to get hydrated and achieve a state of quasi-equilibrium before erosion and the advance of solvent front through the matrix occur) were calculated from each dissolution profile. The similarity factor (f2) was also calculated for each dissolution profile against the target dissolution profile. A simple Higuchi-type equation was used to analyze the drug release profiles. Statistical analysis using analysis of variance (ANOVA) and similarity factor (f2) values calculated from the data indicated no significant difference among the t50% values and dissolution profiles respectively for all formulations. Within the 3.3-6 kp hardness range investigated, dissolution rates were found to be independent of tablet hardness for all the formulations. Although significantly shorter lag times were observed for the tablets formulated with low- and high-viscosity HPMC mixtures in comparison to those containing a single grade of HPMC, this change had no significant impact on the overall dissolution profiles indicated by the similarity factor f2 values. From this study it can be concluded that lot-to-lot variability in apparent viscosity of HPMC should not be a concern in achieving similar dissolution profiles. Also, results indicated that within the viscosity range studied (12,000-19,500 cps) an HPMC mixture of two viscosity grades can be substituted for another HPMC grade if the apparent viscosity is comparable. Also, the drug release is diffusion-controlled and depends mostly on the viscosity of the gel layer formed.

Analysis of Variance↗
PubMed1995

Frequent use of menfegol spermicidal vaginal foaming tablets associated with a high incidence of genital lesions.

Menfegol is a spermicide with in vitro activity against human immunodeficiency virus (HIV). A randomized placebo-controlled safety study covered the use of menfegol foaming tablets for 14 days at increasing frequencies of insertion by 125 prostitutes in Dakar, Senegal. The frequencies of colposcopically diagnosed genital lesions were 5.0%, 11.8%, 27.8%, 49.7%, and 29.4% among menfegol recipients when tablets were used once every other day or 1, 2, 4, or 8 times a day, respectively (P < .05). Among placebo recipients, frequencies were 11.1% and 23.5% when tablets were used < 8 times daily and 8 times daily, respectively. There was no association between subjective genital symptoms and the incidence of colposcopically detected lesions. The high incidence of genital lesions when menfegol foaming tablets were used more than once daily suggests that their frequent use should not be recommended to prevent HIV transmission. In use at low frequency, the tablets' toxicity might be balanced by anti-HIV properties. Safety studies on vaginal microbicides should use objective methods, such as colposcopy, to assess the incidence of lesions.

Adult↗
PubMed2001

Mesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitis.

BACKGROUND: High doses of mesalazine usually result in an inconvenient dosage schedule and reduced compliance. The goal of this trial was to compare the effects of mesalazine 4 g daily given as prolonged-release granules in packets of 1 g with that of prolonged-release tablets of 0.5 g. METHODS: Two hundred twenty-seven patients with mild-to-moderate ulcerative colitis were randomized to treatment with two packets twice daily (Gr-b.i.d.), 1 packet four times daily (Gr-q.i.d.) or 2 tablets four times daily (Ta-q.i.d.) for 8 weeks. A disease activity index (ulcerative colitis disease activity index: UC-DAI) was calculated, and the granules were defined as noninferior to the tablets if the lower limit of the 95% CI for the differences was more than -1 UC-DAI score unit. RESULTS: Noninferiority of the granules compared with the tablets was demonstrated. The mean improvement in the UC-DAI in the treatment groups Gr-b.i.d., Gr-q.i.d., and Ta-q.i.d. were 3.2, 2.9, and 2.4, respectively; the proportion of complete responders in the three groups 39%, 37%, and 31%, respectively. There were no differences in side effects. CONCLUSION: Mesalazine 4 g daily given as prolonged-release granules twice and four times daily is at least as effective as prolonged-release tablets four times daily in patients with mild to moderate ulcerative colitis. The patients preferred the twice daily dosing.

Adolescent↗
PubMed1991

Analgesic efficacy of controlled-release dihydrocodeine. A comparison of 60, 90 and 120 mg tablets in cold-induced pain.

A prospective, double-blind, single-dose placebo-controlled four-part crossover study of 12 healthy volunteers was carried out to compare the analgesic efficacy of controlled-release dihydrocodeine tablets 60, 90 and 120 mg (DHC Continus tablets, Napp Laboratories) in cold-induced pain. Subjects received each of the four treatments in a random order using a latin square design. On each of the four study days, the volunteers performed cold pressor tests, before dose and again at 4, 8 and 12 hours after dose. Subjects rated their pain continuously over a 120-second period using a visual analogue scale. At 4 hours there was a significant reduction in pain in subjects who received 120 mg or 90 mg tablets compared with placebo, and in subjects who received 120 mg tablets compared with those who received 60 mg tablets. At 8 hours, 120 mg and 90 mg dihydrocodeine were still better than placebo. There was no significant difference in side effects between treatments.

Adolescent↗
PubMed1979

Serum levels of phenytoin and phenobarbital in epileptic patients treated with mixture antiepileptic tablets, Comital-L or Hydantol-F.

Serum levels of both phenytoin and phenobarbital were determined by homogenous enzyme immunoassay in 59 epileptic patients treated chronically with either Comital-L or Hydantol-F tablets. The majority of the patients receiving Comital-L tablets showed low serum levels of phenytoin and high serum levels of phenobarbital, while patients treated with the usual daily dosage of Hydantol-F tablets showed adequate therapeutic serum levels of both phenytoin and phenobarbital. From the results obtained, the dose ratio of phenobarbital to phenytoin in Comital-L tablet seemed inappropriate to obtain adequate therapeutic serum levels of both drugs simultaneously. Since the dosage of each anticonvulsant drug used concurrently should be established individually, the use of such fixed-dosage mixture tablets of antiepileptic drugs as Comital-L or Hydantol-F in daily clinical practice should be reconsidered from the viewpoint of serum level monitoring of antiepileptic drugs.

Anticonvulsants↗
PubMed2000

Rectal absorption of lamotrigine compressed tablets.

PURPOSE: Interruption of oral drug administration poses a significant clinical problem for antiepileptic drugs that have no parenteral formulation. If a drug is absorbed rectally, rectal administration can be a useful alternative when the oral route of administration is not possible. The purpose of this study was to compare the single-dose pharmacokinetics of lamotrigine (LTG) compressed tablets after rectal and oral administration in healthy volunteers. METHODS: A single LTG compressed tablet (100 mg) was administered orally and rectally to 12 volunteers in this single-dose, two-period, crossover study with a 2-week washout between doses. For rectal administration, tablets were crushed and suspended in 10 mL of water. Plasma samples were collected from 0 to 120 hr after each dose and analyzed for LTG by an HPLC method developed for this investigation. RESULTS: LTG plasma concentrations were lower after rectal administration versus oral administration. The average area under the curve was 28.90 +/- 9.5 microg/mL/hr after rectal administration and 51.71 +/- 19.2 microg/mL/hr after oral administration. The average maximum LTG concentration was 0.53 +/- 0.14 microg/mL after rectal administration and 1.45 +/- 0.35 microg/mL after oral administration. The relative bioavailability for LTG compressed tablets was 0.63 +/- 0.33 for rectal administration. There were no drug-related rashes or serious side effects. CONCLUSIONS: LTG suspension prepared from LTG compressed tablets is absorbed rectally, although not to the same extent or rate as when given orally.

Administration, Oral↗
PubMed2005

Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial.

BACKGROUND AND AIMS: Preliminary data have shown that delayed release oral mesalamine (Asacol) dosed at 4.8 g/day provided additional efficacy benefit compared to 1.6 g/day in patients with mildly to moderately active ulcerative colitis. Additionally, Asacol dosed at 2.4 g/day has been proved to be more effective than 1.6 g/day. Whether 4.8 g/day of mesalamine (dosed with an investigational 800 mg tablet) is more effective than Asacol 2.4 g/day (dosed with a 400 mg tablet) in patients with moderately active ulcerative colitis is unknown. METHODS: A randomized, double-blind, controlled trial (ASCEND II) was conducted to evaluate the efficacy of 4.8 g/day of mesalamine in adults with active ulcerative colitis. Three hundred eighty-six patients with mild to moderate ulcerative colitis were randomized for treatment with mesalamine 2.4 g/day (400 mg tablet) or 4.8 g/day (800 mg tablet) for 6 wk. The primary efficacy population was 268 patients with moderately active ulcerative colitis treated with 2.4 g/day (n = 139) or 4.8 g/day (n = 129). The primary endpoint was the proportion of patients in each treatment group that achieved overall improvement ("treatment success," defined as either complete remission or a clinical response to therapy) from baseline at week 6. RESULTS: Seventy-two percent of patients receiving 4.8 g/day of mesalamine for moderate ulcerative colitis (89/124 patients) achieved treatment success at week 6, compared with 59% of those who received 2.4 g/day (77/130 patients) (p= 0.036). Both regimens were well tolerated. Adverse events and clinically significant changes in laboratory results were similar in both treatment groups. CONCLUSIONS: Patients with moderately active ulcerative colitis treated with 4.8 g/day of mesalamine (800 mg tablet) are significantly more likely to achieve overall improvement at 6 wk compared to patients treated with 2.4 g/day.

Administration, Oral↗
PubMed1986

The effect of media and other variables on the BP solution rate test for slow lithium carbonate tablets.

The British Pharmacopoeial test for assessing the solution rate of slow lithium carbonate tablets has been evaluated using 'controlled release' tablets containing 400 mg of lithium carbonate. No significant differences in lithium release were found when the volume of media used in the test was reduced from 250 ml to 200 ml, the final stage of the test in pH 6.8 phosphate buffer reduced from 5 to 3 h, the number of tablets in each thimble reduced from three to one, or the prescribed phosphate buffers replaced with phthalate and Tris, respectively. A four-fold increased concentration of phosphate in the phosphate buffers used resulted in a significant retardation in lithium solution rate. This was not attributable to an ionic strength effect but possibly to the formation of trilithium phosphate at the interface. Dissolution studies using the USP Basket Method showed a significantly slower release rate of one tablet into 900 ml of phosphate buffer compared with Tris buffer. This difference was markedly increased when three tablets were investigated in 200 ml of similar media. These differences were considered to be due to the formation of the much less soluble trilithium phosphate in the phosphate buffers.

Delayed-Action Preparations↗
PubMed2004

Absolute bioavailability and absorption characteristics of divalproex sodium extended-release tablets in healthy volunteers.

Conventional delayed-release, enteric-coated divalproex sodium tablet has an absolute bioavailability of approximately 100%. Divalproex sodium extended-release (ER) tablet is a novel formulation of valproic acid (VPA) designed to release the drug slowly at a constant zero-order rate. The purpose of this study was to evaluate the absolute bioavailability and absorption characteristics of divalproex ER. Healthy adult volunteers (n = 16) received divalproex ER and intravenous VPA in crossover fashion. Absolute bioavailability was calculated as the divalproex ER/intravenous VPA ratio of area under the curve extrapolated to infinity. The duration and rate of absorption of VPA from divalproex ER tablets were determined by deconvolution analysis. The geometric mean absolute bioavailability of divalproex ER was 0.896. The mean (coefficient of variation) duration of drug absorption from divalproex ER was 21.8 (17%) hours, and the zero-order absorption rate was 21.6 (24%) mg/h for a 500-mg tablet. Divalproex ER has a lower absolute bioavailability than conventional divalproex tablets but exhibits good extended-release characteristics without any dose dumping.

Adolescent↗
PubMed2001

Pharmacokinetics of buspirone extended-release tablets: a single-dose study.

The objective of this study is to evaluate the absorption of buspirone and its biotransformation to 1-(2-pyrimidinyl) piperazine (1-PP) from two different extended-release (ER) formulations of buspirone HCl tablets (12-hour and 24-hour in vitro release) and from a commercially available immediate-release (IR) tablet. A single dose of the 30 mg ER tablets was compared with two doses of the 15 mg IR tablet administered 12 hours apart. Eighteen healthy male subjects participated in this randomized, open-label, three-treatment crossover study. Blood samples were obtained at 22 time points from predose (0 hour) until 36 hours postdose, and plasma concentration of buspirone and 1-PP was determined by LC/tandem mass spectrometry method. The pharmacokinetic parameters AUC0-t, AUC0-infinity, Cmax, tmax, Ke, and t1/2 were calculated and statistically analyzed. The results indicated extended release of buspirone from the two test products in vivo with a 70% to 90% greater bioavailability in comparison with the IR formulation. The bioavailability of 1-PP from ER formulations appears to be equal to that from the IR formulation. Both buspirone ER tablets successfully delivered bioavailable buspirone with a reduction in peak drug and metabolite plasma levels, prolonged buspirone plasma concentrations, and decreased ratio of 1-PP to buspirone concentration with less intersubject variation when evaluated as a single-dose study in healthy human subjects.

Administration, Oral↗
PubMed2003

Comparison of effects of bleach and cleansing tablet on reflectance and surface changes of a dental alloy used for removable partial dentures.

Proper hygienic care of removable partial dentures is important for maintaining a healthy oral mucosa. A daily home care routine is the responsibility of the patient to maintain oral hygiene. A dentist must inform the patient about denture cleansers used for plaque control. Common denture cleansers may negatively affect the surface of alloys used to make partial dentures. The purpose of this study was to evaluate whether bleach and cleansing tablet have deleterious effects on the surface of a dental alloy used to fabricate removable partial dentures. Nineteen test specimens were prepared from CoCr dental alloy. The specimens were cast into 10 mm long x 10 mm wide x 1 mm thick. Fresh solutions made from a commercial bleach and a commercial cleansing tablet were used for each treating. Three groups (commercial denture cleansing tablet, bleach and tap water) were tested. Six specimens were immersed in 200 mL of tap water containing a single denture cleansing tablet. Two spoons of the commercial bleach was added to 200 mL of tap water. Seven specimens were treated. The control specimens were immersed in 200 mL of tap water. Six specimens were the control group. Each specimen was immersed for 30 min per day in the solution for a period of 30 days. The specimens were analyzed for reflectance with a spectrophotometer, for surface changes with a light microscope and weight which was measured with sensitive balance before and after treatment. The SPSS program was used for the statistical analysis. The Kruskal-Wallis Test and Wilcoxon Signed Ranks Test was used. No significant changes of reflectance was shown in the Kruskal-Wallis Test (p > 0.05). The Wilcoxon Signed Ranks Test was performed for comparison into groups. The difference between before and after treatment was statistically significant for the commercial denture cleansing tablet and the commercial bleach (p = 0.028) (p < 0.05). Reflectance was decreased after treatment. Within the limitations of this study, the commercial cleaning solutions had influenced the decrease of reflectance on the surface of the dental alloy. This solutions should not be limitlessly used on dentures with metal components, because they caused clinically significant reflectance changes on the surface of the alloy after 30 days.

Dental Alloys↗