Omeprazole pellets

Turkoglu M, Varol H, Celikok M. Tableting and stability evaluation of enteric-coated omeprazole pellets. Eur J Pharm Biopharm 2004 57 277-86. 

In a very recent study, fluidized bed manufactured, enteric-coated, omeprazole pellets compressed into tablets were analyzed using neural networks.From the model, the authors were able to predict a positive correlation between the tablet strength and the concentration of the microcrystalline cellulose used as a compression aid. However, the degradation of the omeprazole in such media was also dependent on the microcrystalline cellulose concentration. 

Other Formulations. Neural networks have been applied to the modeling of pellet formulations to control the release of theophylline [63] and to control the rate of degradation of omeprazole [64]. They have also been applied to the preparation of acrylic microspheres [65] and to model the release of insulin from an implant [66]. In arecent study from Brazil, the release of hydrocortisone from a biodegradable matrix has been successfully modeled [67]. 

All products include omeprazole as active ingredient. Losec and Prilosec are original medicinal products in Europe and USA respectively. MUPS (Multi Unit Pellet System) is also an original trade name and drug formulation... 

Difficuity swaiiowing - For patients who have difficulty swallowing capsules, add 1 tablespoon of applesauce to an empty bowl, open the omeprazole capsule, and empty the pellets onto the applesauce. Mix the pellets with the applesauce and swallow immediately. Do not heat or chew the applesauce. Do not chew or crush the pellets. Do not store the pellet/applesauce mixture for future use. 

The infrared (IR) absorption spectrum of omeprazole was obtained in a KBr pellet using a Perkin-Elmer IR spectrophotometer. The IR spectrum is shown in Fig. 4.8, where the principal peaks were observed and the assignments for the major IR absorption bands are listed in Table 4.6. 

Tuncel and Dogrukol-Ak [29] developed a flow-through spectropho-tometric method for the determination of omeprazole in pharmaceutical preparations containing enteric-coated pellets. Sample was dissolved in 100 ml 0.1 M sodium hydroxide and filtered. Portions were analyzed by flow-through spectrophotometry using a Spectrophoresis 100 system with 75 ym fused-silica capillaries with detection at 305 nm. Samples were pumped through the system for 2 min. Results were compared with those obtained by standard spectrophotometry at 305 nm. Detection limits was 8 fiM omeprazole and the calibration graph was linear. The pellet matrix did not interfere. RSD was 1.9% (n = 6). 

Dogrukol-Ak and Tuncel [47] determined omeprazole in capsules by polarographic techniques. An enteric-coated pellet was mixed with one drop of 1 M sodium hydroxide, made up to 100 ml with deoxygenated water then vigorously shaken. Analysis was carried out with a... 

Dogrukol-Ak et al. [55] determined omeprazole in pharmaceutical preparations by a TLC densitometric method. Pellets from eneric coated capsules were finely powdered and dissolved in ethanolic 0.05 M potassium hydroxide with sonication. Four microliters of the solution was subjected to TLC on a silica gel FG254 plates with chloroform-methanol-25% ammonia (97.5 2.5 1) as mobile phase and densitometric detection of omeprazole (Rf = 0.46) at 302 nm. Calibration graphs were linear for 0.42—1.68 jug omeprazole the detection limit was 25 ng. In the determination of omeprazole in 20 mg Omeprazit, Omeprol, and Losec capsules, the found amounts were 20.2, 20.3, and 19.8 mg omeprazole, respectively, with corresponding RSD 1.9,1.8, and 1.6% (n = 8). The results agree with those of UV spectrophotometry. 

Schubert et al. [72] developed and validated a liquid chromatographic method for the determination of omeprazole in powder for injection and in pellets. The analyses were performed at room temperature on a reversed-phase Ci8 column of 250 mm x 4.6 mm (5 /im). The mobile phase, composed of methanol-water (90 10) was pumped at a constant flow-rate of 1.5 ml/min. Detection was performed on a UV detector at 301 nm. The method was validated in terms of linearity, precision, accuracy, and ruggedness. 

Palummo et al. [173] comparatively evaluated the stability of capsules containing 20 mg of omeprazole, in enteric-coated pellets, from seven pharmaceutical laboratories on Argentine market. The stability test was... 

Omeprazole multiple unit pellet system (MUPS) 20 mg/day and pantoprazole 40 mg/day for 8 weeks were more effective than lansoprazole 30 mg/day in relieving heartburn in a randomized, double-bhnd trial in 461 patients with sjmptomatic reflux esophagitis (15). Patient satisfaction and adverse effects were similar in the three groups. The most common adverse effects were diarrhea, headache, and nausea. 

Mulder CJ, Westerveld BD, Smit JM, Oudkerk Pool M, Otten MH, Tan TG, van MUligen de Wit AW, de Groot GH, Dutch omeprazole MUPS study group. A double-blind, randomized comparison of omeprazole Multiple Unit Pellet System (MUPS) 20 mg, lansoprazole 30 mg and pantoprazole 40 mg in symptomatic reflux oesophagitis followed by 3 months of omeprazole MUPS maintenance treatment a Dutch multicentre trial. Eur J Gastroenterol Hepatol 2002 14(6) 649-56. 

Several active substances are unstable in an acidic environment and will degrade when in contact with gastric juice. Examples are omeprazole, pantoprazole, erythromycin and pancreatic enzymes. Such active substances are formulated in a tablet or pellets covered with an acid-resistant layer, a so-called enteric coating. The acidic nature of the polymers used in these coatings prevents dissolution in the gastric environment. The coating will dissolve in the small intestine (with higher pH values), after which the active substance is released. Alternatively, the active substance may be used in... 

Astra, the pioneer of the PPI area, invented a pharmaceutical formulation of omeprazole individually enteric-coated pellets dispensed in hard gelatin capsules [7]. Lansoprazole is presented in a similar capsule formulation [8], wheras pantoprazole [11] and rabeprazole [12] are formulated as single-unit enteric-coated tablets. In some markets Astra has recently also introduced a tablet containing a multitude of small, individually enteric-coated pellets [13]. 

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