WO2000048585A1 - Effervescent laxatives - Google Patents
Effervescent laxatives Download PDFInfo
- Publication number
- WO2000048585A1 WO2000048585A1 PCT/US2000/004701 US0004701W WO0048585A1 WO 2000048585 A1 WO2000048585 A1 WO 2000048585A1 US 0004701 W US0004701 W US 0004701W WO 0048585 A1 WO0048585 A1 WO 0048585A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- peg
- formulation according
- effervescent
- formulation
- acid
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
Definitions
- the present invention is directed to a novel over-the-counter (OTC) laxative as an improved, replacement therapy to current stimulant laxatives.
- OTC over-the-counter
- the FDA has continued to pressure the OTC stimulant laxative category, reclassifying remaining approved stimulants: senna, cascara, aloe, bisacodyl, from Category I (safe and effective) to Category HI (more data needed), and requiring manufacturers to provide updated carcinogenicity and genotoxicity evaluations for these laxative actives. Failure to meet this mandate, and/or prove safety will result in further delisting of laxative actives from the tentative final monographs (TFM), (Fed. Reg. 63: 33592-33595, June 19, 1998).
- TBM tentative final monographs
- PEG polyethylene glycol
- the PEG is mixed with various salts to provide a laxative action with osmotic balance. This is required when the products are used in the high volumes (2-4 L) required for colonic purgation and cleansing.
- these PEG-containing agents provide excellent colonic cleansing prior to GI surgical or colonoscopic procedures. They neither stimulate water and electrolyte secretion into the GI tract, nor do the products result in significant water and electrolyte absorption; essentially, the volume of ingested liquid simply passes through the GI tract. For this indicated usage as a bowel evacuant, patients are instructed to drink 2 to 4 liters over several hours.
- US Patent 5,710,183, Halow, G. discloses a PEG composition with a fiber bulking agent for clinical treatment of constipation and/or diarrhea.
- WO 87/00754 discloses a low-sodium laxative and lavage solution containing PEG with various electrolytes added such as sodium, potassium, chloride and bicarbonate.
- DE 3807712, Deyhle et al. discloses a laxative formulation also containing electrolytes, PEG, alkali hydrogen carbonate and citric acid.
- RU 2111741 Chumak et al. discloses use of a reduced lavage volume, 2 liters, of PEG with an electrolyte solution.
- the electrolyte mixture contains sodium bicarbonate and citric acid which may be in an amount sufficient to provide effervescence.
- WO 98/43654 Jacob et al., is directed towards a non-aqueous colonic purgative containing magnesium salts and potentially polyethylene glycol.
- JP 4198126 OTSUKA PHARM CO LTD discloses a liquid preparation of PEG and electrolytes along with ⁇ -aminoacid. for colon irrigation.
- the -amino acids are used as antioxidants to stabilize PEG and prevent formation of formaldehyde. This was an attributed problem of PEG-based laxatives early in their product life. Use of the highly purified PEG's today overcome these issues. The levels of product 0.01 % range (0.1 g/L) are also too low to provide any appreciable effervescence.
- the present invention is directed to a pharmaceutical formulation comprising polyethylene glycol (PEG) 3350, and a pharmaceutically acceptable effervescent coupling system.
- PEG polyethylene glycol
- Another aspect of the present invention is a method of administering to a mammal, an effective amount of the above noted pharmaceutical formulation for the treatment of constipation, or for the treatment of fecal impaction, in a mammal in need thereof.
- the present invention is directed towards an effervescent formulation of an osmotic bowel evacuant solution, such as a polyethylene glycol based product.
- an effervescent formulation of an osmotic bowel evacuant solution such as a polyethylene glycol based product.
- the effervescent/PEG osmotic formulation offers an alternative that provides for a new, and safe, product as a replacement to the current technologies.
- the PEG based osmotic formulations have proven to be both safe and highly physician recommended.
- an effervescent/PEG based formulation, for use as an OTC laxative would require consumption of a much smaller volume, such as one or two 4-8 oz doses over a 24 hour period.
- Several published studies have shown utility of the PEG-based technology for use as a laxative with low-volume dosage. E. Corazziari, D. Badiali, F.L. Habib, G. Reboa, G. Pitto, G. Mazzacca, F. Sabbatini, R.
- one aspect of the present invention is the use of an osmotic acting composition containing polyethylene-glycol based systems, ( preferably, PEG 3350 NF, or PEG 4000 NF, in combination with an effervescent coupling system, which is diluted with a suitable volume of a liquid, such as water, or juice.
- a suitable volume of a liquid such as water, or juice.
- the effervescent couple comprises a basic ingredient and an acidic ingredient, the basic ingredient liberating carbon dioxide when it and the acidic ingredient are contacted with added water.
- the amount of the effervescent couple is selected at a level sufficient to cause a "fizzy reaction" without itself causing discomfort in the patients mouth.
- the effervescent couple typically comprises citric acid or sodium hydrogen citrate and sodium bicarbonate, but other physiologically acceptable acid/alkaline or alkaline earth metal carbonate mixtures may be used, for example tartaric, adipic, fumaric or malic acids, and sodium, potassium or calcium (bi)carbonates or sodium glycine carbonate.
- flavouring agents may result in optimization of taste characteristics when there is an excess of acidic component, for example, on a chemical molecular equivalent basis of from about 11:3 to 4:3 expressed as the ratio of acidic to basic component.
- acidic component for example, on a chemical molecular equivalent basis of from about 11:3 to 4:3 expressed as the ratio of acidic to basic component.
- citric acid and sodium bicarbonate this may represent 5: 1 to 1: 1 on a weight basis.
- the weight of the acidic component in the formulation may be in the range 7% to 31%, preferably 9% to 18%, by weight.
- the weight of the basic component in the formulation may be in the range 7% to 32%, preferably 9% to 18%, by weight.
- Preferred combinations comprise sodium bicarbonate with citric acid (or sodium hydrogen citrate) or malic acid in a weight ratio of 2: 1 to 1: 1.
- potassium bicarbonate for part or all of the sodium bicarbonate as the basic component of the effervescent couple.
- substitution of potassium bicarbonate for sodium bicarbonate is at a ratio of approximately 1.2: 1.
- Potassium bicarbonate can be used with any of the above acid components.
- the preferred level of the coupling agents, preferably bicarbonate and citrate for an effervescence mixture is about 2.3 gram NaHCO3 (sodium bicarbonate) and 2.2 gram citric acid. This dose provides very significant ANC (acid neutralizing capacity) approximately 20 mEq. However, the levels can be reduced by a factor of 4-5 and still provide some degree of effervescence (e.g., 0.5 g NaHCO3 and 0.4 g citric acid).
- excipients may be added to the formulation, such as flavouring agents, colouring agents, sweetning agents, antioxidants, and other well known agents for stability and packaging considerations.
- a preferred PEG for use herein is PEG 3350, a nonabsorbable and inert polymer of about 3,000 molecular weight.
- PEG 3350 a nonabsorbable and inert polymer of about 3,000 molecular weight.
- the range of PEG 3350 for a 125 to 240 ml reconstitution in liquid will be from a about 5 grams to about 30 gms, preferably from about 10 to about 20 gms, more preferably 13 to 17 grams. Treatment may be once or more daily, up to 4 times daily, but preferably once daily.
- the resulting effervescent/PEG-based formulations when made into a liquid dosage are non-viscous and are optimally be provided to consumers as either bulk powder, or preferably as single dose powder sachets, for dissolution in a suitable liquid, such as water or juice.
- a suitable liquid such as water or juice.
- the product would dissolve rapidly (within seconds) and completely, and does not thicken on standing.
- performance attributes Based on volume consumed (e.g., one or two 4-8 oz doses), performance attributes would be consistent with those presently desired by stimulant laxative users (rapid action, clean-out), but without the negative side-effects of cramping and gas, and without systemic exposure potentially harmful agents.
- the required dosage for use as a laxative may be one which is equivalent to the "minimally effective dose", i.e., one that requires 2 to 3 days treatment before significant effect, having a similar onset and action to the bulk fiber based laxatives. Or the dosage could be increased to be equivalent in action to the current stimulant based products, having an earlier onset of action (a few hours to overnight).
- the present invention is useful as primary treatment for both occasional and chronic constipation, and for the treatment of fecal impaction (at a higher dose).
- Another aspect of the present invention is the treatment of upper GI symptoms associated with such constipation, such as heartburn or bloating.
- the composition herein may also be used for other constipation related disorders, such as irritable bowel syndrome, diverticular disease, and hemorrhoids.
- EXAMPLE 1 A preferred example provides as sachet for reconstitution in 240 ml water for use as laxative.
- PEG System
- the PEG solution is combined with effervescent coupling system and packaged as a sachet to be added to a 8 ounce glass of water.
- EXAMPLE 2 Another preferred examples provides as sachet for reconstitution in 240 ml water for use as laxative.
- PEG System
- the PEG solution is combined with effervescent coupling system and packaged as a sachet to be added to a 8 ounce glass of water.
- PEG System Another preferred examples provides as sachet for reconstitution in 125 - 180 ml water for use as laxative.
- the PEG solution is combined with effervescent coupling system and packaged as a sachet to be added to a 4-6 ounce glass of water.
- PEG System 13.12 g PEG 3350
- the PEG solution is combined with effervescent coupling system and packaged as a sachet to be added to a 4-6 ounce glass of water.
- EXAMPLE 5 Provided as sachet for reconstitution in 125-200 ml water for use as laxative.
- PEG System
- PEG solution is combined with effervescent coupling system and packaged as a sachet to be added to a 4-6 ounce glass of water.
- EXAMPLE 6 Provided as sachet for reconstitution in 125-200 ml water for use as laxative.
- the PEG solution is combined with effervescent coupling system and packaged as a sachet to be added to a 4-6 ounce glass of water.
- EXAMPLE 7 Provided as sachet for reconstitution in 125-200 ml water for use as laxative.
- the PEG solution is combined with effervescent coupling system and packaged as a sachet to be added to a 4-6 ounce glass of water.
- the PEG solution is combined with effervescent coupling system and packaged as a sachet to be added to a 4-6 ounce glass of water.
Abstract
Description
Claims
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU36046/00A AU3604600A (en) | 1999-02-22 | 2000-02-22 | Effervescent laxatives |
CA002362355A CA2362355A1 (en) | 1999-02-22 | 2000-02-22 | Effervescent laxatives |
BR0008385-2A BR0008385A (en) | 1999-02-22 | 2000-02-22 | Effervescent laxatives |
JP2000599377A JP2002537248A (en) | 1999-02-22 | 2000-02-22 | Effervescent laxative |
PL00349360A PL349360A1 (en) | 1999-02-22 | 2000-02-22 | Effervescent laxatives |
EA200100785A EA003064B1 (en) | 1999-02-22 | 2000-02-22 | Effervescent laxatives |
KR1020017010689A KR20010102323A (en) | 1999-02-22 | 2000-02-22 | Effervescent laxatives |
EP00914689A EP1154765A4 (en) | 1999-02-22 | 2000-02-22 | Effervescent laxatives |
HK02102792.4A HK1043046A1 (en) | 1999-02-22 | 2002-04-12 | Effervescent laxatives |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12108999P | 1999-02-22 | 1999-02-22 | |
US60/121,089 | 1999-02-22 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09913685 A-371-Of-International | 2001-08-16 | ||
US10/071,638 Continuation US6444198B1 (en) | 1999-02-22 | 2002-02-07 | Effervescent laxatives |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2000048585A1 true WO2000048585A1 (en) | 2000-08-24 |
Family
ID=22394460
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2000/004701 WO2000048585A1 (en) | 1999-02-22 | 2000-02-22 | Effervescent laxatives |
Country Status (14)
Country | Link |
---|---|
EP (1) | EP1154765A4 (en) |
JP (1) | JP2002537248A (en) |
KR (1) | KR20010102323A (en) |
CN (1) | CN1341016A (en) |
AU (1) | AU3604600A (en) |
BR (1) | BR0008385A (en) |
CA (1) | CA2362355A1 (en) |
CZ (1) | CZ20013043A3 (en) |
EA (1) | EA003064B1 (en) |
HK (1) | HK1043046A1 (en) |
HU (1) | HUP0105351A3 (en) |
PL (1) | PL349360A1 (en) |
WO (1) | WO2000048585A1 (en) |
ZA (1) | ZA200106888B (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1048297A2 (en) * | 1999-04-20 | 2000-11-02 | Braintree Laboratories, Inc. | Use of polyethylene glycol for reducing of intestinal gas, cramping and anorectal irritation |
WO2005110371A1 (en) * | 2004-05-11 | 2005-11-24 | Stefan Spiess | Macrogol preparation |
US9211337B2 (en) | 2011-01-28 | 2015-12-15 | Braintree Laboratories, Inc. | Method, composition and package for bowel cleansing |
US9808497B2 (en) | 2011-11-06 | 2017-11-07 | Jiva Pharma, Inc. | Formulations of concentrated prunes and prebiotics as laxatives and dietary supplements |
US10555970B2 (en) | 2009-04-21 | 2020-02-11 | Dark Canyon Laboratories, Llc | Colon lavage system |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2005320935B2 (en) * | 2004-12-30 | 2012-02-16 | Given Imaging Ltd. | Device, system and method for in-vivo examination |
CN101002832B (en) * | 2006-09-02 | 2011-01-05 | 江西农业大学 | Granulated quickly dissolving medicine for relaxing bowel |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4946939A (en) * | 1989-05-30 | 1990-08-07 | The Dow Chemical Company | High purity polyether polyols |
US4948591A (en) * | 1988-05-10 | 1990-08-14 | Tokai Capsule Co., Ltd. | Soft capsular preparation of sodium picosulfate |
US5124144A (en) * | 1989-04-17 | 1992-06-23 | Giuliani S.P.A. | Orally administered pharmaceutical composition for use in gastrointestinal washes, in particular for diagnostic use, or as a cathartic laxative |
US5710183A (en) * | 1995-07-14 | 1998-01-20 | Halow; George M. | Laxative/antidiarrheal composition comprising polyethylene glycol and fiber bulking agent |
US6048901A (en) * | 1999-04-20 | 2000-04-11 | Braintree Laboratories, Inc. | Method of reducing intestinal gas, cramping and anorectal irritation |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB942743A (en) * | 1959-05-22 | 1963-11-27 | Welloome Foundation Ltd | Oestrogen preparations and the manufacture thereof |
GB1518364A (en) * | 1976-05-05 | 1978-07-19 | Beecham Group Ltd | Pharmaceutical composition |
US4093710A (en) * | 1976-07-07 | 1978-06-06 | Sandoz, Inc. | Rapid dissolving effervescent granules |
-
2000
- 2000-02-22 PL PL00349360A patent/PL349360A1/en not_active Application Discontinuation
- 2000-02-22 EA EA200100785A patent/EA003064B1/en not_active IP Right Cessation
- 2000-02-22 WO PCT/US2000/004701 patent/WO2000048585A1/en not_active Application Discontinuation
- 2000-02-22 JP JP2000599377A patent/JP2002537248A/en not_active Withdrawn
- 2000-02-22 EP EP00914689A patent/EP1154765A4/en not_active Withdrawn
- 2000-02-22 CN CN00804156A patent/CN1341016A/en active Pending
- 2000-02-22 BR BR0008385-2A patent/BR0008385A/en not_active IP Right Cessation
- 2000-02-22 HU HU0105351A patent/HUP0105351A3/en unknown
- 2000-02-22 CA CA002362355A patent/CA2362355A1/en not_active Abandoned
- 2000-02-22 KR KR1020017010689A patent/KR20010102323A/en not_active Application Discontinuation
- 2000-02-22 CZ CZ20013043A patent/CZ20013043A3/en unknown
- 2000-02-22 AU AU36046/00A patent/AU3604600A/en not_active Abandoned
-
2001
- 2001-08-21 ZA ZA200106888A patent/ZA200106888B/en unknown
-
2002
- 2002-04-12 HK HK02102792.4A patent/HK1043046A1/en unknown
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4948591A (en) * | 1988-05-10 | 1990-08-14 | Tokai Capsule Co., Ltd. | Soft capsular preparation of sodium picosulfate |
US5124144A (en) * | 1989-04-17 | 1992-06-23 | Giuliani S.P.A. | Orally administered pharmaceutical composition for use in gastrointestinal washes, in particular for diagnostic use, or as a cathartic laxative |
US4946939A (en) * | 1989-05-30 | 1990-08-07 | The Dow Chemical Company | High purity polyether polyols |
US5710183A (en) * | 1995-07-14 | 1998-01-20 | Halow; George M. | Laxative/antidiarrheal composition comprising polyethylene glycol and fiber bulking agent |
US6048901A (en) * | 1999-04-20 | 2000-04-11 | Braintree Laboratories, Inc. | Method of reducing intestinal gas, cramping and anorectal irritation |
Non-Patent Citations (1)
Title |
---|
See also references of EP1154765A4 * |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1048297A2 (en) * | 1999-04-20 | 2000-11-02 | Braintree Laboratories, Inc. | Use of polyethylene glycol for reducing of intestinal gas, cramping and anorectal irritation |
EP1048297A3 (en) * | 1999-04-20 | 2002-05-08 | Braintree Laboratories, Inc. | Use of polyethylene glycol for reducing of intestinal gas, cramping and anorectal irritation |
WO2005110371A1 (en) * | 2004-05-11 | 2005-11-24 | Stefan Spiess | Macrogol preparation |
US10555970B2 (en) | 2009-04-21 | 2020-02-11 | Dark Canyon Laboratories, Llc | Colon lavage system |
US9211337B2 (en) | 2011-01-28 | 2015-12-15 | Braintree Laboratories, Inc. | Method, composition and package for bowel cleansing |
US9566300B2 (en) | 2011-01-28 | 2017-02-14 | Braintree Laboratories, Inc. | Method, composition and package for bowel cleansing |
US10052295B2 (en) | 2011-01-28 | 2018-08-21 | William A. Shaver | Method, composition and package for bowel cleansing |
US10596135B2 (en) | 2011-01-28 | 2020-03-24 | William A. Shaver | Method, composition and package for bowel cleansing |
US11241404B2 (en) | 2011-01-28 | 2022-02-08 | William A. Shaver | Method, composition and package for bowel cleansing |
US9808497B2 (en) | 2011-11-06 | 2017-11-07 | Jiva Pharma, Inc. | Formulations of concentrated prunes and prebiotics as laxatives and dietary supplements |
Also Published As
Publication number | Publication date |
---|---|
CZ20013043A3 (en) | 2001-11-14 |
PL349360A1 (en) | 2002-07-15 |
BR0008385A (en) | 2002-01-29 |
JP2002537248A (en) | 2002-11-05 |
EP1154765A1 (en) | 2001-11-21 |
HUP0105351A3 (en) | 2004-06-28 |
EA003064B1 (en) | 2002-12-26 |
CN1341016A (en) | 2002-03-20 |
HUP0105351A2 (en) | 2002-05-29 |
HK1043046A1 (en) | 2002-09-06 |
KR20010102323A (en) | 2001-11-15 |
CA2362355A1 (en) | 2000-08-24 |
ZA200106888B (en) | 2002-09-27 |
EA200100785A1 (en) | 2002-04-25 |
EP1154765A4 (en) | 2004-12-01 |
AU3604600A (en) | 2000-09-04 |
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