60/984,034, filed Oct. 31, 2007.

“Shelf stability”, for purposes of this invention, is measured by storing the dosage form in its primary packaging at 40° C., at a relative humidity of about.

Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:Hypersensitivity to any component of these products. The relationship to therapy with famotidine has been unclear in many cases. No. A granulate for oral suspension that is particularly useful for the storage and reconstitution of famotidine into a liquid suspension.

When famotidine was given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 or 40 mg of famotidine was raised to about 5.Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Stability Storage Oral Conventional 60-mg Tablets and Extended-release Tablets. Lupin receives FDA approval for Famotidine for Oral Suspension Mumbai, July 01, 2010: Pharma Major, Lupin Limited announced today that its U.S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received final approval for the company’s Abbreviated New Drug Application (ANDA) for Famotidine for Oral Suspension (40 mg / 5 mL) from the US Food and Drug Administration (FDA). Healing was defined as complete resolution of all erosions or ulcerations visible with endoscopy. Also, caregivers were instructed to provide conservative treatment including thickened feedings. 1 mL.

b.i.d. Also, no antiandrogenic effects were noted (see Orally administered famotidine is incompletely absorbed, and its bioavailability is 40 to 45%. Most patients (27/35) continued into the treatment-withdrawal phase of the study.

Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. The study patients ranged in age at entry from 1.3 to 10.5 months (mean 5.6 ± 2.9 months), 57% were female, 91% were white and 6% were black. Measure dosage with a calibrated device for accuracy. Duration of inhibition of secretion by doses of 20 and 40 mg was 10 to 12 hours.After intravenous administration, the maximum effect was achieved within 30 minutes.
The relationship to therapy with Famotidine has been unclear in many cases. Famotidine is eliminated by renal (65 to 70%) and metabolic (30 to 35%) routes. The ODT samples were prepared as single or combinations of each taste-masking method using a novel suspension spray-coating method including a placebo.


Sulfonic acids, containing the group OSOThe sucrose can be any type of sugar including baker's grade (all pass through a 140 mesh screen), confectionary grade, and milled sucrose, and preferably is confectionary grade containing approximately 3-4 wt % starch.The weight ratio of famotidine to citric acid in the final product is preferably from about 10:1 to about 20:1, and is more preferably from about 15:1 to about 16:1. Table 4 reports the amounts of ingredients contained in the final formulation.Table 5 displays the results of stability testing for the formulations prepared according to Example 2. [51477] The second granulate also preferably comprises one or more preservatives selected from sodium benzoate, sodium methyl paraben, sodium propyl paraben, and combinations thereof, at a preservative:organic acid weight ratio of from 1 to 20, or from 2 to 10.The granulates also preferably comprise xanthan gum, and in a preferred embodiment the first granulate comprising xanthan gum at a xanthan gum: famotidine weight ratio of from 0.05 to 1.0, or from 0.1 to 0.5. Similarly, in pediatric patients 1 to 15 years of age, intravenous doses of 0.5 mg/kg were associated with a mean AUC similar to that seen in adults treated intravenously with 40 mg. Limited published studies also suggest that the relationship between serum concentration and acid suppression is similar in pediatric patients 1 to 15 years of age as compared with adults. Available for Android and iOS devices. © 2004-2020 FreePatentsOnline.com.