FIELD OF INVENTION

[0001] The present invention generally relates to a pharmaceutical composition useful for enhancing sexual peak performance. More particularly, the present invention relates to a synergistic herbal composition comprising Sodium succinate salt of extract of Panax notoginseng fibrous exudate along with acceptable pharmaceutical excipients to possess excellent storage stability. The present invention also relates to the process for preparation of the said herbal composition.

BACKGROUND OF THE INVENTION

[0002] Sexual drive is influenced by biological, psychological, and social factors, but it can also be affected by medications and medical conditions. Many prescription drugs and narcotics (e.g., antidepressants, anxiolytics, antihistamines, antihypertensives, adrenergic receptor blockers, antipsychotics, and opioids) can negatively impact sexual desire, inhibit erection, ejaculation, or orgasm, and so on. Contrariwise, many aphrodisiac substances can improve sexual performance. In particular, substances of natural origin have been used worldwide for millennia in traditional medicines to boost sexual desire, sexual pleasure, or sexual behaviour and the use of psychoactive and/or stimulant drugs during intercourse.

[0003] Sanqi ginseng (Panax notoginseng) has long been used as a medication and food complement in Asian countries. It is one of the most important adaptogens and general tonics that are broadly consumed in preparing traditional Chinese medicine and a component of western herbal remedies. In addition, Panax notoginseng has been known as a natural sexual enhancer.

[0004] Panax notoginseng consists of various active components that exist in all parts of the herb such as triterpene glycosides or saponins which are commonly called ginsenosides, proteins, amino acids, phenols, alkaloids, polypeptides, and vitamins Bl and B2. Possible action mechanisms of Panax notoginseng that can be effective in improving sexual behaviours include various pathways. First, enhancing the stimulation of nitric oxide production from endothelial cells, which is by relaxing the smooth muscle of the corpus cavemosum resulting in a clitoral erection. Next, improving blood circulation enhances the vasomotor tone, and has potential benefits in improving cardiovascular risk factors including hypertension, hyperglycemia, and hyperlipidemia.

[0005] A lot of herbal compositions have developed in the past that use ingredients derived from Panax notoginseng enhancing sexual behaviors.

[0006] PCT Patent Publication No: W02020100052 relates to an oral composition comprising active ingredients derived from an extract oi Panax notoginseng, and extracts from both Moringa, and rutin genus. This composition is capable of treating disorders caused by an alteration of the physiological mechanisms of the male sexual sphere, in particular of erection, with antioxidant, ergogenic, cardioprotective, neuroprotective, vasoprotective, and metabolic activities, vasodilators, and stimulant testosterone hormone.

[0007] US Patent Publication No: 20210315954 relates to a composition in the form of an oral dosage unit or supplement for increasing sexual desire and/or pleasure in an individual. The composition includes an effective combination of damiana (Turnera diffusa), ginseng (Panax notoginseng), saffron, theacrine, potassium nitrate, vitamin Bl 2, and vitamin C taken as an oral dosage unit, pill, or capsule.

[0008] US Patent Publication No: 20210015779 relates to a composition in the form of an oral dosage unit for enhancing peak sexual performance. The composition comprises an absorption enhancer derived from Panax notoginseng along with excipients selected from the group consisting of hydroxypropyl methylcellulose, rice concentrate, and silica. The composition further improves sexual performance, including increased duration of sexual intercourse, increased satisfaction with sexual intercourse, and improved erectile function.

[0009] On analyzing the literature pertaining to herbal sexual enhancers, there appears need in the art to provide an oral composition using Panax notoginseng that possesses excellent storage stability.

OBJECT OF INVENTION

[0010] Accordingly, object of the present invention is to provide a herbal composition for enhancing sexual peak performance.

[0011] Another object of the present invention is to provide a herbal composition having excellent storage stability.

[0012] Another object of the present invention is to provide a herbal composition comprising sodium succinate salt of extract of fibrous exudate of Panax notoginseng along with acceptable pharmaceutical excipients for enhancing sexual peak performance.

SUMMARY OF THE INVENTION

[0013] Accordingly, the present invention provides a herbal composition for enhancing sexual peak performance.

[0014] In an aspect of the present invention, the herbal composition comprising the Sodium succinate salt of extract of Panax notoginseng plant fibrous exudate along with acceptable excipients for sexual peak performance. [0015] In an aspect of the present invention, the herbal composition is in the form of jelly and can be administered orally to increase sexual desire for an acute period of time or over a long period of time.

[0016] The herbal composition of the present invention may be a pharmaceutical or nutraceutical composition.

[0017] The pharmaceutical/nutraceutical excipients in the composition comprise the Penetration enhancer, surfactant and solubilizer such as Epocutol (Diethylene Glycol Monoethyl Ether)

[0018] The herbal composition of the present invention further comprises the acceptable excipients selected from Antioxidant, perfuming agent, chelating agent, Rheology modifier, Humectant, Buffering agent, cathartic, solvent and the like alone or in combinations thereof.

[0019] In an aspect, the herbal composition comprises of Epocutol in an amount of 2-6% w/w, , Propylene glycol in an amount of 5-15% w/w, Hydroxy ethyl cellulose in an amount of 1-10% w/w, Sorbitol in an amount of 4-12%w/w, Propyl gallate in an amount of 0.01-0.10% w/w, Sodium phosphate in an amount of 3-7% w/w, Disodium phosphate in an amount of 5-8% w/w, Ethylenediamine tetraacetic acid (EDTA) in an amount of 0.15-0.35% w/w and water.

[0020] In a preferable aspect, the herbal composition comprises of Epocutol 2%, Propylene glycol 6%, Hydroxy ethyl cellulose 3%, Sorbitol 5%, Propyl gallate 0.05%, Sodium phosphate 5%, Disodium phosphate 7%, Ethylenediamine tetraacetic acid (EDTA) 0.25% and water.

[0021] In an aspect, the herbal composition of the present invention is a colourless jelly. In another aspect, the present invention provides a process for preparing Sodium succinate salt of extract of Panax notoginseng plant comprising;

(i) Separating the fibrous exudate from Panax notoginseng plant;

(ii) Extracting the fibrous exudate with water; and

(iii) adding succinic anhydride to the aqueous extract of step (ii) to obtain the product.

[0022] In an aspect, the concentration of the actives present in the aqueous extract ranges between 6-20%w/w.

[0023] In yet another aspect, the present invention provides a method of formulating the Sodium succinate salt of extract of Panax notoginseng fibrous exudate into jelly composition comprising adding in suitable amounts the pharmaceutical/ nutraceutical excipients to said Sodium succinate salt extract.

[0024] In yet another aspect of the present invention, the Sodium succinate salt of extract of Panax notoginseng fibrous exudate acts synergistically with the other excipients to effectively enhance a subject's orgasm.

[0025] The herbal composition of the present invention shows excellent stability at ambient temperature.

[0026] In another aspect of the present invention, the herbal composition is safe and exhibits excellent storage stability.

DETAILED DESCRIPTION OF THE INVENTION

SOURCE OF BIOLOGICAL MATERIAL

The plant Panax notoginseng is obtained from Himalayan foot hills of India. While the invention has been disclosed with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt to a particular situation or material to the teachings of the invention without departing from its scope.

[0027] Accordingly, to accomplish the objectives of the present invention, the inventors propose a jelly composition useful for enhancing sexual peak performance.

[0028] In an embodiment, the present invention relates to a herbal composition comprising the Sodium succinate salt of extract of Panax notoginseng plant fibrous exudate along with acceptable excipients for enhancing sexual peak performance.

[0029] In an embodiment, the aqueous extracts comprise the Sodium succinate salt of flavonoids.

[0030] The pharmaceutical/ nutraceutical excipients in the composition comprise the penetration agent, surfactant and solubilizer such as Epocutol (Diethylene Glycol Monoethyl Ether).

[0031] The herbal composition of the present invention further comprises the acceptable excipients selected from antioxidant, perfuming agent, chelating agent, penetration enhancer, surfactant, solubilizer, Rheology modifier, Humectant, Buffering agent and cathartic in appropriate amounts.

[0032] Accordingly, the present invention discloses a herbal jelly composition, comprising: i. Sodium succinate salt of extract of Panax notoginseng plant as an active in an amount of 6-20%w/w; ii. EPOCUTOL in an amount of 2-6% w/w; iii. Propylene glycol in an amount of 5-15%w/w; iv. Hydroxy ethyl cellulose in an amount of l-10%w/w, v. Sorbitol in an amount of 4- 12%w/w, vi. Propyl gallate in an amount of 0.01-0.10%w/w, vii. Sodium phosphate in an amount of 3-7%w/w, viii. Disodium phosphate in an amount of 5-8%w/w, ix. EDTA in an amount of 0.15-0.35%w/w, and x. water q.s.

In a preferred embodiment, the present invention discloses herbal jelly composition, comprising: i. Sodium succinate salt of extract of Panax notoginseng plant as an active in an amount of 12%; ii. EPOCUTOL in an amount of 2% iii. Propylene glycol in an amount of 6%; iv. Hydroxy ethyl cellulose in an amount of 3%, v. Sorbitol in an amount of 5%, vi. Propyl gallate in an amount of 0.05 %, vii. Sodium phosphate in an amount of 5%, viii. Disodium phosphate in an amount of 7%, ix. EDTA in an amount of 0.25%, and x. water q.s.

In an embodiment, the herbal composition of the present invention is a colorless jelly. This helps in better bioavailability and better absorption of the active ingredient. In yet another embodiment, the jelly composition of the present invention is administered orally.

In another embodiment, the present invention discloses a process for preparing Sodium succinate salt of extract of Panax notoginseng plant comprising;

(i) Separating the fibrous exudate from Panax notoginseng plant;

(ii) Extracting the fibrous exudate with water; and

(iii) adding succinic anhydride to the aqueous extract of step (ii) to obtain the product.

In yet another embodiment, the present invention discloses a method of formulating the Sodium succinate salt of extract of Panax notoginseng fibrous exudate into jelly composition comprising adding in suitable amounts the pharmaceutical/nutraceutical excipients to said Sodium succinate salt extract.

The herbal composition of the present invention shows excellent stability at ambient temperature.

The herbal composition of the present invention may be administered to a subject in need in suitable dosages.

In an embodiment, the present invention relates to the use of the herbal composition for enhancing sexual peak performance.

In yet another embodiment, the present invention discloses a method for enhancing sexual peak performance in the subject comprising providing the herbal composition in an effective amount.

[0033] In an embodiment of the present invention, theherbal composition in the form of colourless jelly is suitable for use as an oral pharmaceutical product and is particularly suitable for use in patients having a decreased ability to swallow and patients whose intake of water has been restricted. [0034] In another embodiment of the present invention, the jelly form ensures storage stability, and good portability and possesses a suitable jelly strength that enables it to be ingested all at once at the time of administration; and which, after being taken, suitably disintegrates in the oral cavity and rapidly releases the active ingredients within the targeted sites. These effects are achievable by using the gelling agent of the present invention.

ADVANTAGES OF THE INVENTION

• The present pharmaceutical composition is suitable for use in patients having a decreased ability to swallow and patients whose intake of water has been restricted.

• The present pharmaceutical composition exhibits excellent storage stability.

• The present pharmaceutical composition is safe and has little to no side effects.

The following example, which includes preferred embodiments, will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for purpose of illustrative discussion of preferred embodiments of the invention.

EXAMPLE

[0035] Example 1: HERBAL JELLY COMPOSITION

Example 2: HERBAL JELLY COMPOSITION Although the invention has been described in detail in the foregoing for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention except as it may be limited by the claims.