FORMULATION DEVELOPMENT AND EVALUATION OF LANSOPRAZOLE DR ODT
Mr. Rajat Kumar Pandeya
M. Pharm., Dept. of Pharmaceutics,
Noida Institute of Engg. & Technology
Greater Noida, India.
Oral disintegrating tablets (ODTs) have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. The popularity and usefulness of the formulation resulted in development of several ODT technologies. This review describes various formulations and technologies developed to achieve fast dissolution/dispersion of tablets in the oral cavity. In particular, this review describes in detail FDT technologies based on lyophilization, molding, sublimation, and compaction, as well as approaches to enhancing the ODT properties, such as spraydrying, moisture treatment, sintering, and use of sugar-based disintegrants. In addition, taste-masking technologies, experimental measurements of disintegration times, and clinical studies are also discussed.
Reference Id: PHARMATUTOR-ART-1421
Gastroesophageal reflux disease or GERD occurs when the lower esophageal sphincter (LES) does not close properly and stomach contents leak back, or reflux, into the esophagus. The LES is a ring of muscle at the bottom of the esophagus that acts like a value between the esophagus and stomach. The esophagus carries food from the mouth to the stomach.
When refluxed stomach acid touches the lining of the esophagus, it causes a burning sensation in the chest or throat called heartburns. The fluid may even be tested in the back of the mouth, and this is called acid indigestion. Occasional heartburn is common but does not necessarily mean one has GERD. Heartburn that occurs more than twice a week may be considered GERD, and it can eventually lead to more serious health problems.
Anyone, including infants, children and pregnant women, can have GERD. Lansoprazole is one of the classes of proton pump inhibitors, which reduce gastric acidity, an important factor in healing acid-related disorders such as gastric ulcer, duodenal ulcer and reflux oesophagitis. It is used to treat gastro-oesophageal reflux disease, ulcers, acid-related dyspepsia and as an adjuvant in the eradication of H. pylori.2,3,4
Granules are of great interest to the pharmaceutical industry for variety of reasons. Pelletized products not only offer flexibility in dosage form design and development, but are also utilized to improve safety and efficacy of bioactive agents. The focal intent of the present cram was to develop a stable, pharmaceutically equivalent, robust and delayed release micro pellet formulation of Lansoprazole.
MATERIALS AND METHODS MATERIALS
Lansoprazole was obtained as gift sample from Active Pharmaceutical Ingredient, Sugar Granules, MCC , HPC and Mg Carbonate from Alkem Research Centre.
Preparation of Lansoprazole microGranules
The prototype microGranules of lansoprazole were prepared using MCC Sphere to optimize the various parameters such as inlet temperature, outlet temperature and air pressure of Fluid Bed Coater. Then formulations of delayed release microGranules of lansoprazole were done using HPC as a release retardant in different concentrations (table 1).
MCC Spheres were sieved through 30#40 and 33% of Granules was taken for drug loading from total batch size. Required quantity of drug was taken and dispersed in specified ml of purified water solution and stirred for 10 minutes. The required quantity of MCC Spheres was taken and dispersed in specified ml of purified water and stirred for 10 minutes to obtain a clear solution. Purified water Solution was mixed with dispersed MCC Sphere solution with stirring. Granules were loaded using dispersion both in to FBC bowl and coated.
Required quantity of Drug loaded Granules was taken for Barrier coating. Required quantity of HPMC was taken and dissolved in specified ml of purified water and stirred until a clear solution was obtained and coating was done (table 2).
Specified quantity of Barrier coated Granules were taken for Enteric coating. Required quantity of Eudragit L30 D55, Talc, Titanium Dioxide, Iron oxide Red and citric acid (Table 2)were taken and dispersed in specified ml of purified water and stirred for 10 minutes to obtain a clear solution. The prepared dispersion was mixed with Eudragit solutions with required quantity of Water solution for pH adjustment and coating was done.
Evaluation of powder blend and Granules
The formulated powder blend were evaluated for compatibility, particle size shape analysis using Malvern particlesizer (MS 2000)5, angle repose6, hausner’s ratio, compressibility index, bulk density, true density and Granule density5, flow rate, Carr’s Index.
Compression of Tablets
The prepared blend was compressed in round shaped tablet 20mg . The weight of tablet 140-160mg , Hardness 60-80N , thickness 2.50-2.60mm and DT is 2-4 min.
In-vitro Dissolution studies
The release of drug from the developed formulations in the environment of gastrointestinal tract was determined using the USP XXIII dissolution apparatus II (Electro lab TDT – 08L). Tablets equivalent to 20 mg of Lansoprazole in beaker containing 900 ml of 0.1N HCl of dissolution media maintained at 37 ± 0.5°C and 100 rpm. After 1 hour the medium was drained without losing the Granules and 900 ml of pre heated buffer solution of pH 6.8 added, study was further continued for 60 minutes at 75 rpm. Aliquot of samples were withdrawn at every 15 minutes each time which was replaced by the same amount of fresh medium.
The samples were Centrifuge at 5000 rpm for 5 minutes of the above solution, and clear supernatant liquid was used. Correction factors for each aliquot were considered in calculation of release profile. Absorbance of sample after proper dilution was measured at 285 nm using HPLC Dionex (chromeleon) against blank. Concentration of drug was determined from the standard plots of the drug in buffer and the percentage drug release was calculated at each sampling time.
NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.
SUBMIT YOUR ARTICLE/PROJECT AT email@example.com
FIND OUT MORE ARTICLES AT OUR DATABASE