Antacids of this Invention

Executive Summary: Antacids of our invention are a totally new concept and on strength of their exceptional qualities are likely to prove to be revolution in treatment of acidity related gastro-intestinal disorders such as Heartburn, Dyspepsia, Gastro-esophageal Reflux Disease (GERD), Ulcers and a number of non-specific gastro-intestinal symptoms.

The inventors see exceptional commercial opportunities in this invention and are on a look-out for a suitable collaborator for its rapid global commercialization.

• Corportations which are already leading in antacid business are the ones which are placed very advantageously to benefit if they take interest in this invention.
• This is an equally good opportunity for those corporations, which are not at present in antacid business, to expand their portfolio of products. Antacids of this invention, being a totally new concept, have no predecessors, and are a gateway to a totally unoccupied new business space.

Distinctive features of this opportunity are as follows:

1. Antacids is a treatment to a category of life style diseases, the global market potential of which is as attractive as that of any successful New Drug Discovery, but shall need a far lesser lead time and expense required for hitting the market shelf from the invention stage.
2. The presently available antacids have disadvantages which leave a vast scope and need for better products.
3. Antacids of this invention potentially overcome most of the disadvantages of the known antacids so far and, in fact, are beneficial nutrients themselves with no plausible side effects.
4. They are one of the most original ideas conceived in acidity treatment so far. There is no competing patents portfolio and practically no freedom-to-operate issues to be dealt with.
5. A part of the product is likely to be eligible as OTC product in a very short time and rest of it may also take a very short time as compared to other New Drug Discovered to become eligible for OTC category.
6. The product of this invention, can be described as a " Platform Product' i. e. which has a very wide application along several lines and its fundamentals are so good that it has come to stay for a very long time.

A note describing technical aspect of this invention is given below as a file as a Non-Confidential disclosure. Inventors shall be happy to provide full disclosure as soon as a Confidentiality Agreement is signed.

Inventors have no reservations for a thorough IPR due-diligence and freedom to operate analysis by their prospective collaborators.

Inventors shall appreciate expeditious handling at highest levels. They are looking forward to wrap up a conclusive agreement by around 1st March 2006. To achieve this goal, they shall be keen to reciprocate fast with parties who shall be fast in initiating a response, initiating evaluation and finalizing negotiations.

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Technical Note 

Merits and business prospects of present invention on antacids:

Inventors’ perspective

Antacids as a major Pharma market: Antacids is a very vibrant, fast growing market related to lifestyle diseases. This is also a market where OTC drugs are most profitable proposition and are sought after with preference by rule in plenty and thrive in the market. With ever increasing professional competition in the world, a number of those who need transitory treatment by OTC drugs is ever increasing.

Limitations of presently available antacids: However, the drugs that are presently available are far inadequate in their efficacy and they have several undesirable side effects. Inadequacies of present range of drugs are fully covered by this invention.

Presently available antacids are broadly divided into two groups.

• First group is composed of inorganic, acid neutralizing antacids.
• Second group is composed of Active Pharmaceutical Ingredients (APIs)  which act to regulate metabolism to generate an effect of lowering the acidity by various ways such as Proton-pump-inhibitors (such as Lansoprezole, Omeprezole), H₂ – receptor antagonists (such as Cimetidine, Famotidine, Nizatidine, Ranitidine).

The antacids of the second group are available only on prescription and are not meant for treatment of occasional bouts of minor to medium episodes of acidity. Long  term risks of some of them are not known, and all of them are exposed to risks of unknown drug interactions if other drugs are being taken at the same time. Further, many people tend to avoid metabolic drugs if simpler and equally effective alternative is available.

Problems of inorganic antacids are well known. Undesirable side effects arising from inorganic antacids have been described elaborately in literature. 

• A systemic antacid, such as sodium bicarbonate can cause alkalosis and electrolyte imbalances.
• Most of the antacids are derived from aluminium, calcium and magnesium, which are not so readily soluble. They form relatively insoluble compounds in the digestive tract, however, they are also absorbed systemically leading to toxicity. This absorption may enhance significantly in case of patients having ulcerative conditions.
• Ingestion of large amount of calcium can result in a milk-alkali syndrome which involves hypercalcemia,  alkalosis and renal failure.
• Magnesium containing antacids in the long run can cause hyper magnesemia and diarrhea.
• Aluminium containing antacids in prolonged use can cause phosphate depletion, osteoporosis and osteomalacia as well as neurotoxicity.
• All the toxicities of aluminium-, calcium- and magnesium-containing antacids are common and more pertinent in patients with renal failure.

Many proprietary compositions of inorganic antacids aim at using different forms and various combinations of them with a hope to counterbalance the benefits and disadvantages from each of them. However, satisfactory compositions are yet to be found out.

Antacids of this invention: This invention pertains to biochemicals that are part of natural food, and their derivatives. They are extracted from their natural sources in order to make their antacid properties explicitly available and to be able to apply them in therapeutically controlled manner.  

• Best part of it is that they are as effective as inorganic antacids or even better in manner and scope of acid neutralization. They may even qualify to be sold in OTC category as soon as some developmental and a short clinical testing phase is over.
• Antacids of this invention can be mainly divided in two categories, the first one includes those which are known forms of nutrients considered as safe as well as essential in normal diet. The second category is a chemical derivative of these known forms, which may be considered as new unknown forms of chemicals..
• The chemical forms of the first category are the ones, which are useful to control mild and medium episodes of acidity. Being known and natural constituents of food, no toxicity concerns come in picture; what needs to be tested in clinical trials is only their therapeutic efficacy to determine therapeutically effective dose.  These are the forms, which obviously, may qualify for OTC category as soon as cleared for antacid use after demonstrating their therapeutically effective antacid capability. These forms can be commercialized in a very short time. It may be significant here to point it out that the number of patients who need transitory, temporary, intermittent and for an ailment of mild to medium intensity, which is treatable by this class of antacids of our invention, is by far the biggest number of total antacids cases.
• Doubts may be raised about their “derivatives” which have very high acid neutralization capacity. They may be needed in advanced acidity cases, such as in case of open ulcers. In such cases, for some period, a strong and rapid onset acid neutralization effect is required to ensure that stomach acids are neutralized rapidly and pH is maintained above 5. This ensures that pepsinogen is not converted to pepsin that attacks open wounds. These are not natural forms existing in nature as nutrients. However, the chemistry is such that as soon as they come into contact with acids in stomach, their activity immediately neutralizes the acids and they themselves decompose and revert back to natural beneficial nutrient forms. The products of this neutralization reaction does not leave behind any chemical entity which is not natural. Clinical trials may be required for this form only to drive away any fears of unanticipated toxicity of the derivative forms, which otherwise are least likely to be toxic themselves, most likely to be metabolically inactive or inert even if they remain for a long time in the derivative form after ingestion. Incidentally, number of patients who have come to such an acute stage is smaller in number. This component of business is relatively small.

In summery, in whatever form, the antacids of this invention have practically no possibility of serious side effects that are unmanageable in a long run and have potential to offer  very safe OTC antacids which can also be used in long term treatment.

It is obvious that invention with these merits is naturally positioned to rapidly become global and win lion’s share in existing global antacids market.

Interested parties are welcome to contact at info@iprmanagement.com