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At least 703 records · Page 39Linked to original sources

PubMed2005

Frosta: a new technology for making fast-melting tablets.

The fast-melting tablet (FMT) technology, which is known to be one of the most innovated methods in oral drug delivery systems, is a rapidly growing area of drug delivery. The initial success of the FMT formulation led to the development of various technologies. These technologies, however, still have some limitations. Recently, a new technology called Frosta (Akina) was developed for making FMTs. The Frosta technology utilises the conventional wet granulation process and tablet press for cost-effective production of tablets. The Frosta tablets are mechanically strong with friability of < 1% and are stable in accelerated stability conditions when packaged into a bottle container. They are robust enough to be packaged in multi-tablet vials. Conventional rotary tablet presses can be used for the production of the tablets and no other special instruments are required. Thus, the cost of making FMTs is lower than that of other existing technologies. Depending on the size, Frosta tablets can melt in < 10 s after placing them in the oral cavity for easy swallowing. The Frosta technology is ideal for wide application of FMTs technology to various drug and nutritional formulations.

Administration, Oral↗

PubMedDate not supplied

Evaluation of esophageal transit of tablets and capsules in 30 cats.

We have reported tablet-induced focal esophagitis and esophageal stricture formation in cats. The proposed mechanism is thought to be abnormal esophageal tablet retention resulting in focal esophagitis with subsequent stricture formation. The objective of this study was to evaluate the passage of tablets and capsules when given alone (dry swallow) and when followed by a water bolus (wet swallow) to determine if this could, in part, explain the esophageal stricture formation we have observed in cats. Fluoroscopy was used to evaluate tablet or capsule passage after administration. The percentage of dry tablet swallows that successfully passed into the stomach was 0.0% at 30 and 60 seconds, 6.7% at 90 seconds, 13.3% at 120 seconds, 26.7% at 180 and 240 seconds, and 36.7% at 300 seconds. Wet tablet swallows successfully passed 90.0% of the time at 30 seconds, 93.3% of the time at 60 seconds, and 100.0% of the time thereafter. The percentage of dry capsule swallows that successfully passed was 16.7% at each time interval. Wet capsule swallows successfully passed 96.7% of the time at 30 seconds and 100% of the time thereafter. For each time interval, wet swallows achieved significantly greater percentage passage into the stomach when compared to dry swallows (P < .05). This study shows that tablets or capsules given by dry swallow have prolonged retention in the esophagus compared to those given by wet swallow. On the basis of this study, we recommend the routine administration of a water bolus to cats receiving tablets or capsules PO to facilitate esophageal clearance. This practice may help prevent medication-associated esophagitis or stricture formation.

Administration, Oral↗

PubMed2006

Sumatriptan fast-disintegrating/rapid-release tablets.

Sumatriptan is a serotonin 5-HT(1B/1D) receptor agonist that is used for the acute treatment of migraine attacks. A new fast-disintegrating/rapid-release sumatriptan tablet (sumatriptan FDT/RRT) has been developed with the goal of speeding absorption and onset of effect compared with standard sumatriptan tablets. Bioequivalence of sumatriptan FDT/RRT tablets to standard sumatriptan tablets was established in healthy volunteers. Initial data suggest that sumatriptan FDT/RRT tablets may disintegrate faster and get emptied from the stomach faster than standard sumatriptan tablets. In a randomised, double-blind, multicentre, early intervention trial in adults with mild migraine, significantly more sumatriptan FDT/RRT 50 and 100mg recipients than placebo recipients were pain free or migraine free 2 hours after receiving study medication. Compared with placebo, pain relief was significantly greater with sumatriptan FDT/RRT 100mg at 25 and 17 minutes following administration, and with sumatriptan FDT/RRT 50mg at 50 and 30 minutes following administration, in two randomised, double-blind, multicentre trials in adults with moderate to severe migraine. Sumatriptan FDT/RRT tablets were generally well tolerated; the tolerability profile was similar to that reported for standard sumatriptan tablets in other studies.

Adult↗

PubMed2005

In vitro and in vivo evaluation of guar gum-based matrix tablets of rofecoxib for colonic drug delivery.

The present study was carried out to develop and evaluate guar gum-based matrix tablets of rofecoxib for their intended use in the chemoprevention of colorectal cancer. Matrix tablets containing 40% (RXL-40), 50% (RXL-50), 60% (RXL-60) or 70% (RXL-70) of guar gum were prepared by wet granulation technique, and were subjected to in vitro drug release studies. Guar gum matrix tablets released only 5 to 12% of rofecoxib in the physiological environment of stomach and small intestine. The matrix tablets RXL-40 disintegrated completely within 10 h in a dissolution medium without rat caecal contents (control study), and hence not studied further. When the dissolution study was continued in simulated colonic fluids (rat caecal content medium), the matrix tablets RXL-50 were acted upon by colonic bacterial enzymes releasing the entire quantity of drug wherein there was no appreciable difference when compared to that released in control study. The matrix tablets RXL-60 released another 88% of rofecoxib whereas matrix tablets RXL-70 released only 57% of rofecoxib in simulated colonic fluids indicating the susceptibility of the guar gum formulations to the rat caecal contents. The guar gum matrix tablets RXL-70 were subjected to in vivo evaluation in human volunteers to find their ability of targeting rofecoxib to colon. The delayed Tmax, prolonged absorption time (ta), decreased Cmax and decreased ka indicated that rofecoxib was not released significantly in stomach and small intestine, but was delivered to colon resulting in a slow absorption of the drug and making it available for local action in human colon.

Adolescent↗

PubMed1996

The role of intra- and extragranular microcrystalline cellulose in tablet dissolution.

The objective of this study was to examine the influence of intra- and extragranular microcrystalline cellulose (MCC) on drug dissolution from tablets made by high-shear granulation. Granulations were made in a Littleford Model W-10-B (10-liter) mixer and dried in a fluid bed dryer (Niro Inc.). A Plackett-Burman screening design and 2(3) factorial design were employed to study how drug type, MCC (intra- or extra-), filler type (lactose or dicalcium phosphate), disintegrant type (sodium starch glycolate or croscarmellose sodium) and level, proportion of magnesium stearate, and impeller speed affect tablet hardness, disintegration time, and dissolution. Two model drugs were chosen based on their solubility: metoprolol tartrate (solubility > 1000 mg/ml) and hydrochlorothiazide (solubility = 1.05 mg/ml). Tablets were compressed to the same target weight (dose) and similar tablet hardness. In some cases, dissolution testing was also carried out on the loose granules. The intra-extragranular distribution of MCC was found critical to the compactibility and initial dissolution rates from these tablets. Intragranular MCC reduced drug dissolution, the effect being most marked in the case of the slightly soluble hydrochlorothiazide. For formulations containing intragranular MCC, the granulating fluid level on tablet dissolution was also important, since an increase in fluid level resulted in slower drug dissolution from both the loose granules and the tablets compressed from them. Conversely, extragranular MCC tended to increase both dissolution rates and compactibility. It may be concluded that the appropriate distribution of MCC between and within granules may optimize both dissolution and compactibility without changing overall tablet composition.

Cellulose↗

PubMed1976

Application of some polymers in the physiocochemical design of tablet formulation.

Polyethylene glycol 4000 did not apprecialbly affect the rate of drug release from tablets. The use of sodium alginate the a tablet binder showed variable effects on the rate of drug release from the tablet i.e. The incorporation of only 2.5% of sodium alginate caused enhancement in the release rate of the drug based on its action as disintegration inducer. On the other hand, the incorporation of 20, 35 and 50% of sodium alginate showed a pronounced retardation in the rate of drug release from the tablets. This retardation was more pronounced in acid than in alkaline media. Accordingly, sodium alginate could be favourably suggested as tablet binder when retarded gastric absorption is the therapeutic aim required. Carbopol 940 when used as a tablet binder in a concentration of 2.5%, showed a marked enhancement of the release rate of the drug. On the contrary, it exerted a remarkable retardation in the rate of drug release from the tablets when incorporated in the relatively large proportions of 20, 35 and 50%. This retardation was more pronounced in alkaline than in acid media. Accordingly, Carbopol 940 would be favourably suggested in the physiocohemical design of prolonged-release tablet formulations.

Acrylic Resins↗

PubMedDate not supplied

Evaluation of named binders in Rauwolfia vomitoria root tablets.

Some physical properties of Rauwolfia vomitoria root tablets were studied. Tablet characteristics studied were: weight uniformity, tensile strength, friability, disintegration time and content uniformity. Tablet property varied depending on the type and concentration of the binder. The tablets had type and concentration of the binder. The tablets had acceptable hardness and friability profiles. Although tablets containing 150 mg R. vomitoria root had lower tensile strength values. All the tablets passed the B.P. disintegration time test of 15 min. Moreover tablets containing 150 mg R. vomitoria root disintegrated under 1 min. at 4% w/w binder concentration.

Antipsychotic Agents↗

PubMed2001

[Calorimetric evaluation of directly compressed tablets].

The paper studies the effect of the type of the disintegrating substance and the lubricant on the destruction heat of tablet materials and tablets. Destruction heat was determined by means of isoperibolic calorimetry. Tablet materials and tablets contained Avicel PH 101 as the dry binder, 10% of Primojel, Ac-Di-Sol, or Polyplasdone XL as disintegrating substances, and 5% of magnesium strearate or sodium laurylsulfate as the lubricants. The sum of destruction heats of the individual auxiliary substances equalled the found values in tablet materials and tablets. In tablets, in contrast to tablet materials, values of destruction heat higher by 57.9% were found. In the disintegrating substances and lubricants tested, the found values of destruction heats were dependent on the values of destruction heats of the individual auxiliary substances. In the disintegrating substances, a linear dependence of the total destruction heat (CDT) on the destruction heat of the disintegrating substances (DTR) was found, given by the relationship CDT = 0.797.DTR + 17.666 with the correlation coefficient r = 0.986.

Adjuvants, Pharmaceutic↗

PubMed2002

[Preparation of buspirone hydrochloride buccal adhesive tablet and study on its drug release mechanism].

AIM: To prepare buspirone hydrochloride buccal adhesive tablet and investigate factors that influence drug release behavior and the drug release mechanism. METHODS: Buspirone hydrochloride buccal adhesive tablet was prepared with double layers structure composed of drug core and adhesive layer. The materials of the drug core were carbopol 974 and lactose, the adhesive layers were carbopol 974 and HPMC K4M. The influence of drug release factors such as adhesive layer component, adhesive layer weight and adhesive tablet hardness was investigated. The relationship between adhesive layer weight and drug release mechanism in vitro was studied. RESULTS: The results showed that the weight of the adhesive layer and the hardness of adhesive tablet showed significant effects on drug release, but the adhesive layer component showed no significant effect. The optimum prescription of buspirone hydrochloride buccal adhesive tablet was carbopol: HPMC = 1:1, adhesive layer weight = 50%, and adhesive tablet hardness = 4 kg. The study of drug release mechanism from adhesive tablet showed that it was double directions when adhesive layer weight was 20%, and single direction first then double directions when 33.33%, and single direction all along when 50%. CONCLUSION: The speed and direction of drug release from adhesive tablet can be controlled by regulating adhesive layer weight.

Acrylic Resins↗

PubMed1992

Variation of pharmacokinetics after oral administration of slow-release metoprolol tablets and pharmacogenetic considerations.

The maximum plasma concentrations (Cmax) after oral administration of 120 mg tablets of slow-release metoprolol (CAS 37350-58-6) to 75 Japanese healthy male volunteers and 15 arrhythmic patients were measured. Extensive and poor metabolizers after oral administrations of slow-release metoprolol tablets were classified by means of the frequency distribution of Cmax values. In addition, the frequency distribution of Cmax values after oral administration of slow-release metoprolol 120 mg tablets was compared with that of conventional metoprolol 40 mg tablets. 1. Mean +/- S.E. values of Cmax, tmax and AUC0-24 after oral administration of slow-release metoprolol tablets to 75 healthy male volunteers and 15 arrhythmic patients were 95.3 +/- 6.6 ng/ml, 4.4 +/- 0.2 h and 1000.4 +/- 70.9 ng.h/ml, respectively. 2. The number of poor metoprolol metabolizers after the oral administration of slow-release tablets in 75 healthy volunteers and 15 patients was estimated to be 2 subjects (2.2%). 3. The frequency distribution of Cmax values after oral administration of conventional metoprolol tablets was similar to that of slow-release metoprolol tablets. In addition, from the result of this study and that obtained in another study, in which the frequency of poor metoprolol metabolizers in British people has been examined, it is concluded that the frequency of poor metoprolol metabolizers varies between ethnic groups (2.2% in Japanese population and 11.3% in British population.

Administration, Oral↗

PubMed2003

Particular features of photolabile substances in tablets.

Nifedipine and molsidomine tablets are extremely photolabile drug preparations, even at cool room light. Compared to solutions the light spectrum responsible for photodegradation is moved towards the long-wavelength range corresponding to the bathochromic shift of light absorption in the solid state. In the case of nifedipine tablets light up to 500 nm, especially the range between 400-420 nm, is degrading. Molsidomine tablets are affected only by ultraviolet light, but not by visible light. In both cases light penetrates less than 1 mm into the tablets. For nifedipine tablets the exact penetration depth could be determined due to the discolouration of the drug substance upon irradiation. It varied from 360 microm to 880 microm depending on the drug content. Since the decomposition products of nifedipine act as photostabilizers by spectral overlay, light penetration and photodegradation in nifedipine tablets are limited. The formation of gaseous and liquid decomposition products in molsidomine tablets enhances photodegradation. Changes of the tablet structure as well as dissolution and migration processes are discussed. Furthermore the degradation products donot photostabilize the drug substance due to the missing light absorption above 300 nm.

Calcium Channel Blockers↗

PubMed2003

[Technology and analysis of "Askoeziuofito" tablets].

The objective of this work is to produce chewable tablets out of Echinacea purpurea liquid extract (1:1) and ascorbic acid: to create the technology, to select methods of analysis and to examine stability. The paper describes the technology of tablets: a method of condensation is chosen; the influence of additional substances over tableting is established; pressing characteristics of tableting mixtures are examined. The quality of tablets is evaluated in terms of appearance and technological rates: average tablet mass, hardness against pressure, hardness against wearing, time of disintegration, and speed of ascorbic acid secretion. The identity of ascorbic acid, ferments and hydroxycinamon acid was established. Quantities of ascorbic and chicory acids were defined. The tablets produced were named "Askoeziuofito" tablets. The name consists of abbreviated terms of ascorbic acid, Echinacea plant and phytochemical preparation.

Ascorbic Acid↗

PubMed2003

[Study on in vitro dissolution rate of geniposide in huangqin qingfei dispersible tablet].

OBJECTIVE: To study in vitro dissolution rate of geniposide in Huangqin Qingfei dispersible tablet. METHOD: A reversed-phase HPLC method was developed for determination of geniposide. In vitro dissolution rates were compared between Huangqin Qingfei dispersible tablet and conventional tablet in the dissolution medium of pH 1.0, 2.85, 4.5, 6.8, and 8.0 accordingly. Zero-class model, single-index model, logarithm normal school model, and Weibull distributing model were used to simulate the dissolution curve. RESULT: The dissolution rate of two tablets is not affected by pH so much, and they can dissolve within 5 to 10 minutes. Weibull distributing model is the best simulation for in vitro dissolution. Comparing with conventional tablet, dispersible tablet dissolve quickly and completely. CONCLUSION: The in vitro dissolution rate of geniposide in Huangqin Qingfei dispersible tablet conforms to Weibull distributing model. The dispersible tablet is able to release rapidly.

Chromatography, High Pressure Liquid↗

PubMedDate not supplied

The physical characteristics of lyophilized tablets containing a model drug in different chemical forms and concentrations.

Orodispersible tablets, usually prepared using freeze-drying method, are becoming a popular drug formulation for patients who have difficulties swallowing solid dosage forms. The influence of drug solubility and concentration on the physical characteristics of lyophilized tablets composed of mannitol and gelatin was investigated. Phenobarbital and phenobarbital sodium were studied as model drugs. The tablets were analyzed for mechanical strength using a new method employing Instron, a material testing apparatus. For tablets containing phenobarbital in the form of sodium salt, better mechanical strength was demonstrated than for tablets prepared with water insoluble phenobarbital--acid form. Besides, the mechanical characteristics of the tablets indicate that plasticity and porosity were reduced when sodium phenobarbital was incorporated at a higher dose. Lyophilized tablets were not hygroscopic and only a small increase of tablet mass by 1% and 3% was observed after 4 weeks of storage at 40% and 60% RH, respectively. All formulations disintegrated in seconds in water, at a temperature of 37 degrees C.

Drug Compounding↗

PubMed2005

[The pharmacokinetics and bioequivalence of acipimox sustained-release tablets after a single and multiple oral administration in healthy dogs].

AIM: To study the pharmacokinetics and bioequivalence of acipimox sustained-release tablets (SRT) after a single and multiple oral dose in healthy dogs. METHODS: The plasma concentrations of of SRT and reference capsules with a single and multiple oral doses. RESULTS: The drug concentration-time profiles fitted to a noncompartment model. After a single dose administration of sustained-release tablets and capsules, the pharmacokinetic parameters were as follows: AUC were (158 +/- 30) and (147 +/- 37) microg x h x mL(-1); Tmax were (4.3 +/- 0.8) and (2.6 +/- 1.3) h; Cmax were (29 +/- 6) and (42 +/- 10) microg x mL(-1); T(1/2) were (2.3 +/- 0.7) and (1.60 +/- 0.10) h; MRT were (6.0 +/- 0.8) and (3.9 +/- 0.7) h, respectively. The relative bioavailability of the sustained-release tablet was (108 +/- 16) %. After a multiple oral administration of sustained-release tablets and capsules, the pharmacokinetic parameters were as follows: AUC were (209 +/- 23) and (195 +/- 26) microg x h x mL(-1); Tmax were (6.3 +/- 0.8) and (3.4 +/- 1.5) h; Cmax were (27 +/- 4) and (36 +/- 5) microg x mL(-1); Cmmin were (2.2 +/- 1.0) and (0.20 +/- 0.20) microg x mL(-1); Cav were (8.7 +/- 1.0) and (8.1 +/- 1.1) micro x mL(-1); FI were (293 +/- 73) % and (448 +/- 91) % , respectively. The relative bioavailability of the sustained-release tablet was (114 +/- 19) %. CONCLUSION: The results of two one-side test from single dose administration shown that two preparations were bioequivalent. The Cmax of sustained-release tablet was lower than that of capsules, while the Tmax and MRT of sustained-release tablet were higher than that of capsule, which indicating a good retarding effect. The results from multiple dose administration also shown that two preparations were bioequivalent and the DF of sustained-release tablet was significant lower than that of capsule.

Administration, Oral↗

PubMed2006

International harmonization of generic drugs: in vitro dissolution tests for Japanese and American generic tablets.

Ibuprofen tablets on the market in Japan and the USA were compared by manual- and automatic-dissolution tests according to USP24 criteria. Dissolution test were performed in 900 ml of phosphate buffer of pH 7.2 at 37.0+/-0.5 degrees C at 50 rpm for 60 min, and the time required for 70% dissolution (T70%) and 5% dissolution after 60 min (A60) were evaluated. The dissolution profiles of both Japanese and American tablets by the automatic-method showed almost the same profiles as those of the manual method. T70% of the American and Japanese tablets by the manual method were not significantly different (p>0.05) from the automatic-method at various sampling positions. The A60 of the American and Japanese tablets by the manual-method was not significantly different (p>0.05) except at one position. The results indicate that the automatic-method was more reproducible than the manual-method, and also that systematic error was negligible. The T70% and A60 of the American tablets were significantly different (p<0.05) from the Japanese tablets. The American tablets were a film-coated over-the-counter drug and the Japanese tablets were a sugar-coated prescription drug. There was a difference in dissolution behavior between the dosage forms of the two countries.

Absorption↗

PubMed1985

[Antacids--gel or tablet. A randomized, double-blind, placebo-controlled study].

A double blind placebo controlled trial was conducted to compare the effect of two antacid brands (liquid and tablet form) on fasting and postprandial intragastric pH. In 9 healthy volunteers intragastric pH was continuously recorded by solid state memory on 6 occasions. 40 mmol of each antacid was given one hour before and after a standardized meal. The time during which pH was below 3.5 during the first hour following each medication was, in the fasting state, 56.7 +/- 2.1 min. with placebo tablets, 30.7 +/- 8.0 min. (p 0.05) with magaldrate tablets, 26.6 +/- 8.0 min. (p less than 0.01) with Al-Mg-hydroxide tablets, 46.1 +/- 6.1 min. with placebo liquid, 18.4 +/- 5.2 min. (p less than 0.01) with magaldrate liquid, and 21.5 +/- 6.2 min. (p less than 0.01) with Al-Mg-hydroxide liquid. Postprandially the respective periods of time were 48.3 +/- 4.9 min. with placebo tablets, 45.4 +/- 4.6 min. (n.s.) with magaldrate tablets, 48.9 +/- 5.6 min. (n.s.) with Al-Mg-hydroxide tablets, 46.7 +/- 7.9 min. with placebo liquid, 26.6 +/- 9.3 min. (p less than 0.05) with magaldrate liquid, and 28.0 +/- 7.1 min. (p less than 0.05) with Al-Mg-hydroxide liquid. Both tested brands were equally effective. With regard to pH activity, both tested forms were more effective in fasting state than postprandially; tablets showed no measureable activity postprandially and were less effective than the liquid form. The usefulness of the usual medication of low-dosed antacids, one hour postprandially, is open to doubt.

Adult↗

PubMed1984

[Experimental study of acrylic resin coated gentamicin tablets for local antibiotic therapy].

Gentamicin tablets were prepared and evaluated for local antibiotic therapy. Two types of tablet were used. One, a slow release tablet, was coated with acrylic resin (Eudragit R.S.) and another was non-coated. The release of gentamicin from the coated tablets can be controlled by changing the thickness of the film coating. The thickness of the film coating was adjusted to release gentamicin within three weeks when placed in Ringer's solution. Coated tablets were inserted into the bone marrow of rabbits. Thereafter, daily excretion of gentamicin was measured in the urine for three weeks. Constant excretion of gentamicin was seen for ten to fourteen days, which suggests the release of gentamicin from the bone marrow. Plasma concentrations were very low, thus precluding side effects. Non-coated tablets were inserted to the bone marrow by the same method as above. Plasma concentrations of gentamicin peaked in one hour and then rapidly decreased. This pattern is similar to that seen with intramuscular administration. As acrylic resin was non-absorbable material in vivo, the tissue reactions around coated tablets were examined. Histological findings at three weeks, six weeks and six months after insertion, respectively, did not show any severe tissue reactions. The possible use of local therapy by coated antibiotic tablets for bone infections is discussed.

Acrylic Resins↗