Fast Dissolving Dosage Form Research Articles

OPTIMIZATION AND CHARACTERIZATION OF MELOXICAM ORODISPERSIBLE TABLETS USING MIXED HYDROTROPY FOR ENHANCED WATER SOLUBILITY

Introduction: In order to attain rapid discharge in saliva and enhanced absorption, drug was incorporated in a fast-dissolving dosage form (ODTs) as a solid dispersion. In this present work ODTs of Meloxicam were prepared by sublimation techniques where different subliming agents were used with super disintegrant. Materials and Methods: Hydrotropic solid dispersions were prepared using different ratios (1:2, 1:4 and 1:6) of drug and hydrotropic blends (Niacinamide, Anhy. Sodium citrate, Sodium Salicylate and Sodium benzoate). Best hydrotropic solid dispersion was selected to prepare ODTs comprising of croscarmellose sodium and camphor in different concentration along with other pharmaceutical excipients. From the primary trial batches, T3 was selected for optimization experimental designs due to lowest disintegration time and highest in vitro drug release. Secondary batches (F1-F9) were prepared by using 32 full factorial design with different concentration of croscarmellose sodium (12, 14 and 16 mg) and camphor (8, 10 and 12 mg) as two independent variables while disintegration time and percent friability were considered as two dependent response variables. These formulations were subjected to study of various post compression evaluation parameters like hardness, thickness, friability, weight variation, disintegration time (25-117 sec) and in-vitro drug release (99.09%).
 Result and Discussion: Equilibrium solubility studies were reported that by utilizing hydrotropy, the solubility of Meloxicam got enhanced from 20.5 to 140.96 times as compared to its aqueous solubility. The desirability fraction was used to optimize the response variables for specific targets, i.e., minimum disintegration time and maximum dissolution, and the responses obtained were consistent for experimental values.

Central Composite Design for the Development of Trimetazidine Dihydrochloride-Loaded Fast Dissolving Film

A fast-dissolving dosage form is an approach used to improve therapeutic efficacy and bioavailability by avoiding the first-pass metabolism of the cargo. Besides, the approach causes rapid cargo absorption from the pre-gastric area which may outcome in the quick inception of action. The trimetazidine dihydrochloride (TDC) is an anti-anginal drug and there is a prerequisite to provide fast onset of action to treat angina. Therefore, the present work was aimed to prepare and evaluate fast-dissolving oral films (FDOF) of TDC to provide fast onset of action. The FDOF is prepared by using the solvent casting method and it was optimized by employing a central composite statistical design. The two independent variables such as HPMC K4M and PEG 400 are the film-forming polymers which are evaluated at three levels. The dependent variables selected as folding endurance, disintegration time, and % drug release. The formulation was prepared and optimized the batch F-4 showed the least disintegration time (19 s) and the highest drug release (98.55±7.90%). Moreover, the ex-vivo mucus permeation study showed better permeation and satisfying physicochemical properties. As per the above results, we conclude that the prepared formulation could be a novel dosage form to improve drug delivery and patient compliance.

Development of Effervescent Granules with Solid Dispersion of Furazolidone

Introduction. Treatment of infectious and inflammatory diseases demands active substances (AS), characterized by low resistance of microorganisms, high specificity of the mechanism of action and a wide range of antimicrobial activity. Though furazolidone (FZ) – AS meets these criteria, however, practically insolubility in water significantly limits its use. Use of the solid dispersion method (SD) could increase the solubility and dissolution rate of AS with low water solubility. revious studies indicate an increase in the solubility and dissolution rate of FZ in water from SD with polyvinylpyrrolidone-24 000 (PVP-24 000) in a ratio with AS > 6 : 1 by weight. As a result, it becomes possible to introduce SD FZ into the composition of rapidly dissolving effervescent dosage forms, for example, granules for obtaining solutions for external use for the treatment of infectious and inflammatory diseases.Aim. Development of the composition and technology for producing effervescent granules based on solid dispersions of FZ for obtaining a solution for external use.Materials and methods. FZ substance, polyvinylpyrrolidone-24 000 ± 2000 (PVP-24 000 ± 2000), tartaric acid, malic acid, sodium carbonate anhydrous, ethyl alcohol 96 %, purified water. We provided the granules through fluidized bed granulation. The analysis of the obtained granules included the following parameters: description, granule size, loss in mass on drying, disintegration, uniformity of dosage according to GPМ 1.4.1.0004.15 "Granules". Then followed a qualitative and quantitative determination of AS and analysis of the pH of the aqueous solution of the granules. To study the stability and shelf life of the samples of granules, we laid them to the storage in accordance with GPМ 1.10009.15 "Stability and shelf life of drugs".Results and discussion. We developed he composition and technology of FZ effervescent granules for obtaining a solution for external use. Granules are obtained by separate granulation of the main (containing a SD AS) and acid components, followed by mixing in ratios that provide a solution of FZ with a concentration of 0.004 % in water at room temperature. Later we assessed the quality of the obtained compositions and determined, the shelf life (2 years) and storage conditions (in a dry, dark place at a temperature of 25 °C) of the developed compositions of granules.Conclusion. As a result of technological and chemical-pharmaceutical research using the SD method, we developed a new FZ dosage form – effervescent granules, which makes it possible to obtain an aqueous solution with a concentration of FZ 0.004 % in less than 5 minutes without heating. Based on the results of the work, an application was filed with Rospatent No. 2021105988 dated 10.03.2021, "Fast-dissolving dosage form of furazolidone and a method for its production".

Development of fast-dissolving dosage forms of curcuminoids by electrospinning for potential tumor therapy application

Curcuminoids (CUs) of antitumor and various other potential biological activities have extremely low water solubility therefore special formulation was elaborated. New fast dissolving reconstitution dosage forms of four CUs were prepared as fibrous form of 2-hydroxypropyl-β-cyclodextin (HP-β-CD). In the electrospinning process HP-β-CD could act both as solubilizer and fiber-forming agent. The solubilization efficiency of the CU-HP-β-CD systems was determined with phase-solubility measurements. The electrospun CUs were amorphous and uniformly distributed in the fibers according to XRD analysis and Raman mappings. The fibrous final products had fast (<5 min) and complete dissolution. In typical iv. infusion reconstitution volume (20 mL) fibers containing 40–80 mg of CU could be dissolved, which is similar to the currently proposed dose (<120 mg/m2). The in vitro cytostatic effect data showed that the antitumor activity of the CU-HP-β-CD complexes was similar or better compared to the free APIs.

Formulation, Development and Evaluation of Fast Dissolving Oral Film of a Atenolol Drug and validation by RP-HPLC Method using ICH Q2 guidelines

Now a days, fast dissolving dosage forms are gaining popularity, as this dosage form can be administered without water. Rapid dissolving property, avoiding first pass metabolism and majority of the drug is absorbed through buccal/oral mucosa in to systemic circulation. On oral administration of atenolol undergoes first pass metabolism results in reduced bioavailability up to (60%), so the objective of the present study was to formulate and evaluate fast dissolving oral films of atenolol to overcome the limitation of bioavailability and increase patient’s compliance. In recent studies oral films were prepared by solvent casting method using HPMC K15 as a film formers and PEG 400, glycerin as plasticizers and evaluated for mechanical properties, disintegration and in vitro dissolution. Good mechanical properties and in vitro drug release were shown by all formulations. The Comparing to other formulations, the optimized (F5) Formulation (HPMC K15, CCS and PEG 400) Exhibited drug release of 92.12% in 15 minutes which was significantly high. RP-HPLC is simple, fast, precise, sensitive, and reproducible (liquid chromatography) method was developed and validated for the analysis of atenolol drug formulation. Using C-18 HPLC column separation was carried out. This was maintained at ambient temperature. Analysis was carried out by using UV detector at the wavelength 228 nm. The RP-HPLC method was found to be linear over the concentration ranges from 50-100 μg/mL (r2 =0.999). Retention time for atenolol drug formulation was found to be 5.496min. LOQ of method was 5.7308μg/mL and LOD 2.5036μg/mL.&#x0D; Keywords: Atenolol, Fast dissolving oral film, Bioavailability, Mechanical properties, C18, RP-HPLC, Methanol

Synthesis and Characterisation of Starch Glutamate as a Novel Superdisintegrant

Superdisintegrants have been developed to improve the disintegration process of the fast dissolving tablets. Superdisintegrants acts as structural weakner in fast dissolving tablets and helps in the quick breakup of the tablet into small particles. A new novel superdisintegrant starch glutamate has been synthesized by esterification process and characterized by the FTIR, X-ray diffraction and scanning electron microscopy. Starch glutamate physical and micromeritics properties have been evaluated.The prepared starch glutamate was in soluble in aqueous buffers, organic and in-organic solvents tested. It was free flowing, amorphous in nature, having good swelling index, excellent flow property. The swelling index of starch glutamate was found to be 1200 indicating the suitability of starch glutamate as superdisintegrant in the formulation of fast dissolving dosage forms. Keywords: Superdisintegrants, Starch glutamate, Swelling index.

Study on the Solubility of Ketoprofen From Solid Dispersions with Polyvinylpyrrolidone

The solubility of ketoprofen (nonsteroidal anti-inflammatory drug) from solid dispersions based on polyvinylpyrrolidone (PVP-10000, PVP-12600 and PVP-24000) is studied. The use of solid dispersions (SDs) increases the solubility and dissolution rate. The solubility of ketoprofen from SD increases by 1.5–2.6 times. The rate of dissolution from SDs increases by 1.5–3.2 times. The studies conducted by a complex of physical and chemical methods suggest that an improved release of ketoprofen from SDs is due to the generation of solid solution of the active substance in the polymer, the formation of intermolecular hydrogen bonds of the active substance with polyvinylpyrrolidone and the solubilizing effect of the polymer during the dissolution of ketoprofen. The results obtained can be used in the development of fast-dissolving solid dosage forms of ketoprofen with enhanced bioavailability.

CALCIUM SALT OF CARBOXYMETHYLED AEGLE MARMELOS (BAEL FRUIT) GUM: A NOVEL SUPERDISINTEGRANT FOR FAST DISINTEGRATING TABLETS.

The present study was carried out for the preparation of modified Aegle marmelos gum as natural superdisintegrant and assessed it on various parameters for preparing fast dissolving dosage form. The extracted gum from Aegle marmelos fruit is chemically modified by carrying out its carboxymethylation and further complexed with Calcium chloride. Therefore, the natural Superdisintegrant prepared from Aegle marmelos gum followed swelling and wetting mechanism for disintegration of the dosage form. The change in the functional groups of the extracted gum, carboxymethyled gum and the calcium complexed gum was studied by FT-IR spectrophotometer and DSC studies. Pre-compression parameters of the tablet such as Swelling index, bulk density, tapped density, carr’s index, angle of repose and hausner’s ratio were determined. Dummy tablets containing calcium complexed Aegle marmelos gum were formulated to check the disintegrating efficiency of the tablets. The disintegrating properties of calcium complexed Aegle marmelos gum as superdisintegrant was compared with the marketed Superdisintegrant Sodium starch glycolate. The comparison between both the formulations containing different superdisintegrants in various batches was done to check the disintegrating efficiency of the modified Aegle marmelos gum as superdisintegrant. The disintegrating time for calcium complexed Aegle marmelos gum was observed to be 1min±2sec to 1min±5sec showing good disintegrating properties.The present study may serve as a prototype approach for formulation and development of novel superdisintegrant from various natural gums.

Formulation optimization and evaluation of fast dissolving film of aprepitant by using design of experiment

The concept of fast dissolving dosage form has become popular as new delivery system. This system will provide maximum therapeutic efficacy, increased bioavailability and maximum stability by reducing the frequency of dosage. It will also avoid first pass metabolism of the drugs. This system provides more rapid drug absorption from the pre gastric area which may provide quick onset of action. The present research aimed to prepare fast dissolving films (FDF) of aprepitant used in the prevention and treatment of chemotherapy-induced nausea and vomiting. The FDF was prepared using solvent casting method and optimized employing central composite design considering two independent variables film forming polymer (pullulan) and PEG 400. Disintegration time, wetting time, drug release and folding endurance were taken as dependent variables. The prepared optimized formulation showed minimum disintegration time (20 s), highest dissolution rate (88.87%) and satisfactory physicochemical properties. It is evident from the above results that the developed formulation can be an innovative dosage form to improve the drug delivery, onset of action as well as improve patient compliance.

ORAL FAST DISSOLVING DRUG DELIVERY SYSTEM: A MODERN APPROACH FOR PATIENT COMPLIANCE

This review represents importance of mouth dissolving films as compared to other oral dosage forms. Fast dissolving oral drug delivery system are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth without need of water or chewing. First developed fast dissolving dosage form in formulation and the rapid disintegrating properties were obtained through a special procedure or formulation modification, hence mouth dissolving film is proved to be better alternative in such cases. This fast dissolving drug delivery system is suited for the drugs which undergo high first pass metabolism and is used for improving bioavailability. Mouth dissolving film consists of thin oral strip; which release active ingredients immediately after uptake into oral cavity. In present investigation, an attempt has been made to develop oral fast dissolving film. Availability of larger surface area that leads to rapid disintegrating and dissolution in the oral cavity.

FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF ELETRIPTAN FAST DISSOLVING ORAL FILMS

The present study aimed at preparing fast dissolving oral films of Eletriptan as a model drug which is used for the migraine treatment. Fast dissolving dosage forms have acquired great importance in pharmaceutical industry because of their unique properties. In the present research work various trials were carried out using different grades of HPMC E3, E6, and E15, maltodextrin DE6 and other polymers by solvent casting method. The prepared films were evaluated for film thickness, folding endurance, surface pH, morphological properties, % drug content and content uniformity, tensile strength, percent elongation, in vitro disintegration time and in vitro dissolution studies. The optimized formulation F24 prepared using HPMC E15 showed minimum disintegration time (10 sec), highest dissolution rate i.e. 99% of drug within 8 min and satisfactory physicochemical properties. The optimized film was evaluated for its bioavailability compared with pure drug as reference standard. Statistical analysis revealed that no significant difference between the bioavailability parameters of the film and the reference standard indicated that they exhibited comparable plasma level-time profiles. These findings suggest that the fast dissolving film containing Eletriptan is considered to be potentially useful for the treatment of migraine where quick onset of action is desirable.

Optimization of Poly(methyl vinyl ether-co-maleic acid) Electrospun Nanofibers as a Fast-Dissolving Drug Delivery System.

Background:Poly(methyl vinyl ether-maleic acid) (PMVEMA) is a water-soluble, biodegradable polymer used for drug delivery. The aim of the present study was to prepare nanofibers of this polymer as a fast-dissolving carrier for montelukast.Materials and Methods:Polymeric nanofibers were spun by electrospinning method using different ratios of biodegradable polymer of PMVEMA. The processing variables including voltage, distance of the needle to rotating screen, and flow rate of the solution were optimized based on the diameter of the nanofibers, drug content, and release efficiency by a Taguchi design. The morphology, diameter, and diameter distribution of the nanofibers were studied by scanning electron microscopy (SEM). Drug loading and its release rate from the nanofibers were analyzed spectrophotometrically. The possible molecular between the polymer and the drug was characterized with Fourier-transform-infrared spectroscopy.Results:The results showed the best situation for electrospinning of the polymer obtained at the polymer concentration of 37%, the distance of the needle to rotating screen of 19 cm, the voltage of 120 kV, and the rate of injection of 0.2 ml/h. In these situations, the fiber diameter and drug loading efficiency percentage were 273 nm and 83%, respectively. These nanofibers released the total loaded drug within 1–3 s with no residue in the dissolution medium. SEM results showed that the optimized nanofibers were quite smooth and without beads.Conclusions:The results indicated that the nanofibers of PMVEMA could dissolve the drug very rapidly and can be adopted for fast-dissolving dosage forms.

FAST DISSOLVING TABLET USING SOLID DISPERSION TECHNIQUE: A REVIEW

Fast dissolving tablets are also called as mouth-dissolving tablets, melt-in mouth tablets, orodispersible tablets, quick dissolving etc. Fast dissolving tablets are those when put on tongue disintegrate instantaneously releasing the drug, which dissolve or disperses in the saliva. The faster the drug dissolved into solution, quicker the absorption and onset of clinical effect. Oral routes of drug administration have wide acceptance up to 50-60% of total dosage forms. Fast dissolving tablet containing solid dispersion was developed to improve the dissolution of drug and stability of solid dispersion. They are disintegrating and/or dissolve rapidly in the saliva without the need for water. Thus it is regarded as the safest, most convenient and most economical method of drug delivery having the highest patient compliance. The later part of the article focus on the progress in methods of manufacturing, evaluation and various latest technologies involved in the development of Fast dissolving tablets. Solid dispersion is basically a drug–polymer two-component system; the drug–polymer interaction is the determining factor in its design and performance. It also discusses about modern characterization technique to characterize solid dispersion. In this review, it is intended to discuss the recent advances related on the area of solid dispersion technology. Different methods are also been used for preparation of solid dispersions such as Melting method, Solvent method, Melting solvent method, Melt extrusion method, lyophilisation Technique, Melt Agglomeration Process, The Use Of Surfactant, Electro spinning and Super Critical Fluid Technology. The introduction of fast dissolving dosage forms has solved some of the problems encountered in administration of drugs to the pediatric and elderly patient, which constitutes a large proportion of the world's population. Solid dispersions have attracted considerable interest as an efficient means of improving the dissolution rate and hence the bio availability of a range of poorly water-soluble drugs. The focus of one part of the review article is based on solid dispersion mainly advantages, disadvantages, types, the method of preparation, and characterization of the solid dispersion at laboratory and industrial level.

Formulation and Evaluation of Quick Dissolving Films of Promethazine Hydrochloride

Fast dissolving dosage forms have acquired great importance in pharmaceutical industry because of their unique properties like dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for additional liquid. This convenience provides both a marketing advantage and patient compliance. The present study aimed at preparing fast dissolving oral films of Promethazine Hydrochloride oral fast dissolving films that offers a suitable approach for the treatment and management of nausea and vomiting. In the present investigation different types of polymer like HPMC, HPC, polyvinyl pyrolidone, aspartame, poly vinyl alcohol to prepare quick films. The prepared films were evaluated for film thickness, folding endurance, surface pH, morphological properties, % drug content and content uniformity, tensile strength, percent elongation, in vitro disintegration time and in vitro dissolution studies. The physical appearance was found to be good and shows that films were transparent physical appearance was found to be good and shows that films were transparent with smooth surface without any scratches. The folding endurance was showed that films have good flexibility. In-vitro drug release for Promethazine of all the formulations showed 60-90% within four minutes.

In Vitro/In Vivo Evaluation and Bioavailability Study of Amitriptyline Hydrochloride from the Optimized Oral Fast Dissolving Films

The present investigation was undertaken with the objective of developing fast dissolving film(s) of a tricyclic antidepressant drug amitriptyline hydrochloride in order to improve its bioavailability, optimize its therapeutic action especially when used to treat major depression and to enhance the compliance for the developmentally disable, mentally ill, elderly and pediatric patients. Fast dissolving dosage forms have acquired great importance in pharmaceutical industry because of their unique properties. Ten formulations were prepared by solvent casting method using different polymer types, plasticizer types, surfactant concentrations and different ratio of hydroxypropyl methyl cellulose and maltodextrin. The prepared films were evaluated for folding endurance, thickness, drug content, in vitro/in vivo disintegration time, drug release and tensile test. The optimized formula F8 containing HPMC 15cp and maltodextrin in 1:1 ratio showed minimum in vitro/in vivo disintegration time 16.8, 13.2 seconds respectively, highest dissolution rate i.e. T80% 1.1 minutes, D2 min (%) 89.77% and satisfactory mechanical properties. The optimized film was further evaluated for bioavailability compared with a marketed solution (Amitriptyline Hydrochloride®), the study based on cross over design using experimental animals (rabbits). The pharmacokinetic results revealed that the fast dissolving films has higher peak blood concentration (Cmax, 0.927µg/ml) within shorter time (Tmax, 2 hours), indicating rapid absorption and faster onset of action with acceptable bioavailability value. These findings suggest that the fast dissolving film containing amitriptyline hydrochloride is expected to become one of choices for the treatment of acute depression.

Application of Box-Behnken design to formulate and optimize multipolymeric fast dissolving film of rizatriptan benzoate

The present investigation aims at formulation and optimization of multipolymeric fast dissolving film of rizatriptan benzoate. Three film forming polymers namely hydroxypropyl methylcellulose (HPMC), maltodextrin and polyvinylalcohol were explored using Box-Behnken experimental design to derive optimized fast dissolving film formulation using desirability function. Analysis of variance (ANOVA) was performed for five dependent variables tensile strength, folding endurance, load at yield, percentage elongation and percentage drug release in 30 s (Q30). Mathematical regression equations were derived by applying ANOVA and validated using checkpoint batches. Results of the experimental design exposed that the effect of independent factors HPMC and maltodextrin significantly influenced the mechanical properties and percentage drug release from the film. Optimized batch was derived based on set criteria using desirability function. Reponses of the optimized formulation were tensile strength (500 N/m2), folding endurance (203), load at yield (15.06 N/m2), percentage elongation (4.56%) and Q30 (60.03%) falling under acceptable limits. High percentage drug release from the film in simulated saliva and simulated gastric fluid reveal fast dissolving characteristics. Fast dissolving dosage form can help patients with diseases like migraine

Formulation and optimization of fast dissolving intraoral drug delivery system for clobazam using response surface methodology.

Clobazam is a newer 1,5-benzodiazepine used for the treatment of epilepsy. It is better tolerated and less sedating than other benzodiazepines. Absorption of the drug can be impacted by oral fast dissolving dosage form; this may have implications for epilepsy in pediatrics and those having difficulty in swallowing tablets/capsules resulting in improved patient compliance. The purpose of the present investigation was to formulate and optimize clobazam oro-dissolving tablets by direct compression method using response surface methodology (RSM). Oro-dispersible tablets of clobazam were prepared by direct compression method using crospovidone (2-6%) as a superdisintegrant, microcrystalline cellulose (MCC) (20-40%) was used as diluents along with directly compressible mannitol to enhance mouth feel. A 32 full factorial design was applied to investigate the combined effect of two formulation variables: amount of crospovidone and MCC over the independent variables disintegration time, wetting time and percent drug release. Disintegration time showed by all formulations was found to be in the range of 24.3-193 s based on evaluation parameters the formulation containing 6% of crospovidone and 30% of MCC showed promising performance against all other formulations. The results demonstrated that the RSM could efficiently be applied for the formulation of clobazam oro-dispersible tablets; therefore, constitute an advance in the management of epileptic attacks.

Studies of piroxicam absorption by oral mucosa.

The present study was undertaken to investigate, if the non-steroidal anti-inflammatory drug (NSAID) piroxicam (CAS 36322-90-4) Fast-Dissolving Dosage Form (FDDF) can be absorbed in the oral mucosa. Piroxicam FDDF was administrated under the tongue to rats with an oesophagus ligation (OL) to prevent the drug entering the stomach and in turn its absorption by the classic way. A group of sham-operated (SO) animals received the same piroxicam FDDF dose. After drug administration, a pharmacokinetic study with serial serum sample extractions at 0, 15, 30, 60 and 120 min was performed. It has been found a prompt increase in serum piroxicam levels in OL-rats, which showed different pharmacokinetics from SO-rats. Areas under curve (AUCs) of OL-rat serum piroxicam levels were higher at 15, 30 and 60 min compared to SO-animals. These results indicate that piroxicam FDDF is absorbed in the rat oral mucosa. Moreover, during the first hour, drug absorption by oral mucosa rendered higher piroxicam levels than gastric absorption.

Drug-delivery products and the Zydis fast-dissolving dosage form.

Many patients find it difficult to swallow tablets and hard gelatin capsules and do not take their medication as prescribed. It is estimated that 50% of the population is affected by this problem which results in a high incidence of non-compliance and ineffective therapy. The difficulty is experienced in particular by paediatric and geriatric patients, but it also applies to people who are ill in bed and to those active working patients who are busy or travelling, especially those who have no access to water. Such problems can be resolved by means of the Zydis dosage form which does not require water to aid swallowing. The Zydis fast-dissolving dosage form is a unique freeze dried medicinal tablet, made from well known and acceptable materials. When Zydis units are put into the mouth, the freeze dried structure disintegrates instantaneously releasing the drug which dissolves or disperses in the saliva. The saliva containing the dissolved or dispersed medicament is then swallowed and the drug is absorbed in the normal way. Some drugs are absorbed from the mouth, pharynx and oesophagus as the saliva passes down into the stomach. In these cases, the bioavailabilities of drugs from Zydis formulations are significantly greater than those observed from standard dosage forms. This paper deals with the formulation and process technology of the Zydis dosage form. The bioavailability characteristics of Zydis products are summarized, and in particular, the design of Zydis products for the enhancement of oral bioavailability and the improvement of clinical activity, through transmucosal delivery and pregastric absorption, is discussed.

Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sublingual or Intramuscular Piroxicam in the Treatment of Renal Colic

Aims: To investigate the therapeutic effect of the fast-dissolving dosage form (FDDF) of sublingual piroxicam on renal colic compared with the intramuscular (IM) injection form of the same agent in a randomized, double-blind, placebo-controlled clinical trial. Methods: 80 patients were assigned to one of two treatment groups: Group 1 received 40 mg piroxicam FDDF sublingual tablets and IM injection of 2 ml distilled water. Group 2 received an IM injection of 40 mg piroxicam and two sublingual tablets of placebo. At baseline and 30 min after the medication, vital signs were recorded and the pain intensity was evaluated by the patient using a numeric rating scale. Results: The overall efficacy of the treatment was 90%. There was no significant difference with respect to the required rescue treatment (p = 0.328), pain relapse within 24 h (p = 0.434) and the decrease in vital signs and numeric rating scale in both groups (p > 0.05). Conclusion: The piroxicam FDDF tablet was found to be as effective as the IM injection form of the same agent in the treatment of renal colic. The FDDF is a good alternative to the parenteral form because of its earlier onset of action and ease of self-administration which increases patient compliance.