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(12) Patent Application Publication (10) Pub. No.: US 2011/0171295 A1 Shafee Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2011/0171295 A1 Shafee Et Al US 2011 0171295A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0171295 A1 Shafee et al. (43) Pub. Date: Jul. 14, 2011 (54) MIMEDIATE RELEASE COMPOSITIONS OF Publication Classification ACD LABLE DRUGS (51) Int. Cl. A6II 3/4439 (2006.01) (75) Inventors: Muneera Mohamed Shafee, A6IR 9/24 (2006.01) Jeddah (SA); Ruckmani A69/48 (2006.01) Kandasamy, Tiruchirapalli (IN); A6IPI/00 (2006.01) Thusleem Omar Abdulgani, A6IPL/04 (2006.01) Jeddah (SA); Saleem Zainuddin (52) U.S. Cl. .......................... 424/452: 514/338; 424/465 Shaikh, Jeddah (SA); Anand Vasantharao Kondaguli, Jeddah (57) ABSTRACT (SA) The present invention provides a method of creating a macro environment in the stomach for immediate release of acid Assignee: labile compounds stable at alkaline or near alkaline pH com (73) Jamjoom Pharmaceuticals, Jeddah prising the step of administering a composition comprising (SA) acid labile compound stable at alkaline or near alkaline pH together with a water soluble buffer, a water insoluble buffer, (21) Appl. No.: 12/987,367 a disintegrant and pharmaceutically acceptable excipients. The present invention also provides a pharmaceutical com (22) Filed: Jan. 10, 2011 position of a multi component system in which one compo nent essentially contains an acid labile drug and the other component comprises a fast releasing buffer composition Related U.S. Application Data along with pharmaceutically acceptable excipients for oral (60) Provisional application No. 61/293,926, filed on Jan. administration and ingestion by a subject, and process for 11, 2010. preparing the same. Patent Application Publication Jul. 14, 2011 Sheet 1 of 4 US 2011/0171295 A1 pH-Time curve of soluble buffers -- Trisodium Phosphate 80 mg g -- Calcium carbonate 280 mg 8 -- Sodium bicarbonate 350 mg 8 -- Trometharine 1000 mg - 5 4 3. 2 1 3 S 8 Tire in ritutes FIGURE 1 a pH-Time curve of insolubie buffers 8 -- yagnesium. Oxide heavy 88 mg s -- Magnesium Hydroxida 250 mg 2 3. S. 6 fo Erie i lites FIGURE 1b. Patent Application Publication Jul. 14, 2011 Sheet 2 of 4 US 2011/0171295 A1 phi-line curve of combined buffers 3. s 6 f{ fine in minutes -- Trisodium phosphate 250 mg+ Magnesium oxide heavy 100 mg -- Trisodium phosphate 250 mgt Magnesium hydroxide 250 ing -- Sodium bicarbonate 350 mg+ Magnesium oxide heavy 100 mg averomethamine 500 ingt Magnesium hydroxide 250 mg FIGURE 1C pH profile of different buffer combinations 1. B1-MgOf Sp B2-MgOhifTSP 83-NahCOMgO : B4-MgOh! TRIS t 2. 30 O Tire in airtates FIGURE 2 Patent Application Publication Jul. 14, 2011 Sheet 3 of 4 US 2011/0171295 A1 Release profile of AP Pantoprazole with and without buffer -0- AP without buffer rter API with fier SO 3. 4. line in ritutes FIGURE 3 Comparative invitro release of Pantoprazole immediate Release & Delayed Release formulations 50 -- Pantoprazole immediate release -- Pantopazole delayed release s i: S$ SO 00 5. 203 Tire if ites FIGURE 4 Patent Application Publication Jul. 14, 2011 Sheet 4 of 4 US 2011/0171295 A1 in-vitro release of Formulation illustrating microenvironment and macroenvironment pH 1) wn Release at macro pH - Release at micro ph 1. go SS 8 70 2 3. ire initites FIGURE 5 FIGURE 6 US 2011/0171295 A1 Jul. 14, 2011 IMMEDIATE RELEASE COMPOSITIONS OF empty stomach with a glass of water. This minimizes expo ACID LABILE DRUGS Sure time to gastric fluid, as it ensure gastric emptying within about 30 minutes or so, and delivery of the dosage form from REFERENCE TO EARLIER FILED the stomach to the duodenum. Once in the duodenum, opti APPLICATION mal conditions exist for the enteric-coating to dissolve and release the drug into the bloodstream where absorption of a 0001. This application claims the benefit under 35 U.S.C. non-acid degraded drug occurs. If food is ingested contem S119(e) of U.S. Provisional Patent Application No. 61/293, poraneously with the administration of an enteric-coated dos 926, filed Jan. 11, 2010, and titled “IMMEDIATE RELEASE age form, gastric emptying may not only be slowed, but there COMPOSITIONS OF ACID LABILE DRUGS, which is is also an increase in the pH of the stomach from about pH 1 incorporated, in its entirety, by this reference. to about 5 over the next several hours, depending on, for example, the general health of the subject and the composi BACKGROUND tion being administered. When the pH begins to approach 5, 0002 1. Technical Field the enteric-coating begins to dissolve away resulting in pre 0003) The present invention relates to method for creating mature release of the drug into the stomach. a macro environment of buffers for delivering acid labile 10007. In geriatric patients the gastric pH is already pharmaceuticals, stable at alkaline or near alkaline pH and elevated as there is a general decline in gastric acid secretion oral pharmaceutical compositions of acid labile drugs, stable in the stomach with aging. In such patients; enteric coated at alkaline or near alkaline pH and process for the preparation acid labile drugs are less effective. Also, when the ingested of the same in pharmaceutically acceptable dosage forms. food contains any fat, gastric emptying can be delayed for up 0004 2. Background Information to 3 to 6 hours or more, as fat in any form combined with bile 0005 Acid labile drugs such as the proton pump inhibitors and pancreatic fluids strongly inhibits gastric emptying. tend to be unstable at acidic pH and therefore have to be Thus, as a general rule, enteric-coated dosage forms should formulated as enteric-coated dosage forms to prevent acid only be ingested on an empty stomach with a glass of water to degradation. Although these drugs are stable at alkaline pH, provide optimal conditions for dissolution and absorption. they are destroyed rapidly as pH falls (for example, by gastric 0008 To overcome the problems of enteric coated tablets: acid). Or, if the enteric-coating of the composition is dis several scientists used compositions comprising large rupted (for example by chewing) resulting in degradation of amounts of buffers (U.S. Pat. No. 6,489,346 B1, 03/2002 the active ingredient by the gastric acid in the stomach. Upon Jeffrey Owen Philips et al.) to prevent the degradation of acid ingestion, an acid-labile pharmaceutical compound must be labile drugs. protected from contact with acidic stomach secretions to I0009 For instance, certain compositions of omeprazole maintain its pharmaceutical activity. Certain acid labile drug contain 1100 mg of sodium bicarbonate (equivalent to 300 compositions with enteric-coating have been designed to dis mg of sodium) and oral suspension contains 1680 mg of solve at basic or near neutral pH to ensure that the drug is Sodium bicarbonate (equivalent to 460 mg of sodium). Such released in the proximal region of the small intestine (duode formulations utilizes the concept of microenvironment pH num), not in the stomach. However, due to their pH-depen and hence a large quantity of alkali is required to neutralize dent attributes and the uncertainty of gastric retention time, the acid in the stomach so as to protect the uncoated PPI from in-vivo performances as well as inter and intra subject vari acid degradation and maintain intragastric pH>4 for a period ability are very high; making it an uncertain method. Never of about 18 hours. The American Heart Association's recom theless at basic/near neutral pH also most acid-labile pharma mended daily intake of sodium is 2,400 mg for a normal ceutical agents are still susceptible to degradation depending person and, these amounts should be taken into consideration on the particular pKa of the agent. Further as an acid-labile by anyone on a sodium-restricted diet. Also Sodium bicar compound upon ingestion must be transferred in intact form, bonate is contraindicated in patients with metabolic alkalosis i.e., a non-acid degraded or reacted form, to the duodenum and hypocalcemia. Also such compositions weigh about 1.5- where the pH is near or above its pKa, the enteric-coating 2.0 g making it difficult to Swallow and hence leading to must be resistant to dissolution and disintegration in the stom patient non-compliance. Furthermore, since, the amount of ach, that is, be impermeable to gastric fluids while residing in buffer depends on the pKa of the drug used, the amount of the stomach. Additionally, since the therapeutic onset of an alkali required to make an immediate release composition of enteric-coated dosage form is largely dependent upon gastric Pantoprazole or Rabeprazole, may be more than that required emptying time it varies between subjects. In most subjects, for Omeprazole. Moreover, sodium bicarbonate used in the gastric emptying is generally an all or nothing process, and composition has poor stability properties and decomposes by generally varies from about 30 minutes to several hours after converting to carbonate and such; the decomposition is accel ingestion. Thus, for a period of time following ingestion, an erated by agitation or heat. Hence, such compositions com enteric-coated dosage form resides in the low pH environ prising large amount of buffers are also not suitable for long ment of the stomach before moving into the duodenum. Dur term usage. ing this time, the enteric-coating may begin to dissolve, or 0010 All the compositions of prior art are based on the imperfections or cracks in the coating may develop, allowing concept of micro environmental pH which is also known as gastric acid to penetrate the coating and prematurely release virtual pH. The micro environmental or virtual pH can be said drug into the stomach rather than in the small intestine.
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