Use of Polymeric Materials with Other Substances for Improved Performance

Abstract

Methods of enabling or improving the ability of a hydrogel to swell in the stomach of an animal and/or increasing the amount of time said hydrogel remains swollen in the stomach are described herein. In one embodiment, a polymer is administered in combination with one or more pH modifying agents which raise and maintain the pH of the micro environment of the polymer and/or the stomach in order inducing swelling in the polymer. The polymer can be a homopolymer, a copolymer, or a polymer blend or composite. In one embodiment, the polymer is a superabsorbent polymer (“SAP”). The polymers can also be administered with one or more active agents, such as appetite suppressants. The pH modifying agent and/or the active agent can be administered simultaneously with the polymer in the same dosage form, simultaneously with the polymer in separate dosage forms, or sequentially. The compositions are formulated for oral administration. The formulation can include drugs for delivery to the stomach, such as antibiotics, or the hydrogel can be used as a filler, for example, for obesity control. The formulation an also be used to enhance gastric retention, for example, for controlled drug delivery. Methods of delivering a drug are also described herein, along with medicaments for carrying out the methods of the present invention.

Description

RELATED APPLICATIONS[0001]This application claims the benefit of priority to U.S. Provisional Patent Application Ser. Nos. 60 / 786,615, filed Mar. 28, 2006, and 60 / 787,396, filed Mar. 30, 2006, both of which are hereby incorporated by reference in their entirety.FIELD OF THE INVENTION[0002]The present invention is in the field of methods for inducing weight loss and treatment of gastrointestinal disorders through mechanical and physiological means using polymers which are pH dependent by inducing the appropriate stomach pH and by further using the polymers in conjunction with other pharmacological and surgical means to induce weight loss.BACKGROUND OF THE INVENTION[0003]Public health efforts and current antiobesity agents have not controlled the increasing epidemic of obesity. This disorder is increasingly prevalent in industrialized nations because of the abundance of food and the reduced activity levels that accompany the movement of populations from rural to urban settings. Obesit...

AI Technical Summary

Benefits of technology

[0018]In one aspect, the present invention relates to a method of enabling or improving the ability of a hydrogel to swell in the stomach of an animal and / or increasing the amount of time said hydrogel remains swollen in the stomach comprising administering to the animal a water-swellable polymer in combination with one or more substances which raise and maintain the pH of the microenvironment of the polymer and / or the stomach. In a further embodiment, the polymer is a superabsorbent polymer. In a further embodiment, the polymer is selected from the group consisting of homopolymers, copolymers, polymer blends, cross-linked polymers, polymer composites, and combinations thereof. In a further embodiment, the polymer is a polymer composite.

Problems solved by technology

Public health efforts and current antiobesity agents have not controlled the increasing epidemic of obesity.

Obesity is associated with increased morbidity and mortality.

Detrimental effects of obesity on health include an increased risk of cardiovascular disease and the associated conditions of hypertension, diabetes, and hyperlipidemia.

Unfortunately, the mechanisms of fat storage and genetic influences are not, generally speaking, amenable to treatment.

Moreover, the control of feeding behavior and psychological influences require prolonged treatment.

In addition, although the components of energy intake and expenditure are treatable, many obese individuals are resistant to or incapable of engaging in activities which significantly increase their energy expenditure.

These suppressants, however, typically do not create a true feeling of satiation, such as that brought on by a “full” stomach and / or they cause undesirable side-effects, such as anxiety, and hyperactivity and may have adverse side effects.

Amphetamines (dextroamphetamine) have been used as weight loss and anti-obesity drugs, but can cause unacceptable tachycardia and hypertension.

They also have a high rate of abuse potential.

Other sympathomimetic adrenergic agents, including phentermine, benzphetamine, phendimetrazine, mazindol, and diethylpropion, may have adverse cardiovascular side effects, and their indicated use is only short-term (12 weeks), In 2000, the appetite suppressant phenylpropanolamine was removed from United States market because of unacceptable risks of stroke, especially in adult women.

Other weight loss agents, such as orlistat and sibutramine, also can have adverse side effects.

For example, orlistat use frequently results in adverse events including flatus, oily stools, fecal urgency or fecal incontinence, and abdominal pain, particularly among patients who do not follow the recommended low-fat diet.

Consuming large amounts of fiber, however, requires the patient to expel large quantities of fiber which can cause gastrointestinal discomfort.

Others are unable tolerate such high volumes of fiber for other reasons.

None of these drugs and materials, however, has provided a satisfactory means for control of obesity or to induce weight loss with adequate safety for the user.

The swelling of these materials in the stomach can cause a sensation of satiety (i.e., full stomach).

Unfortunately, many hydrogels that could be used for therapeutic purposes including weight loss and obesity treatment do not swell or swell poorly in the acidic pH of the stomach.