Abstract: The present disclosure relates generally to pharmaceuticals. More specifically, the disclosure is directed to a pharmaceutical composition comprising a pharmaceutically active component and an excipient, lyophilized pumpkin seed mucilage obtained from bio-waste pumpkin seeds. The mucilage is a suitable excipient for functioning as a binder, a film former, a mucoadhesive agent, a release modifier, or combinations thereof. The disclosure also provides a process of preparation of the lyophilized pumpkin seed mucilage.
The present disclosure relates generally to pharmaceuticals. More specifically, the disclosure is directed to a pharmaceutical composition comprising a pharmaceutically active component and an excipient, lyophilized pumpkin seed mucilage. The disclosure also provides a process of preparation of the lyophilized pumpkin seed mucilage.
BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art. [0003] Excipients are pharmaceutically inactive components that are employed along with the pharmaceutical actives in all formulations to render functionalities such as stability, binding capacity, or bulkiness to the formulation. They also provide a suitable means for administration of the active in the body so as to ensure biosorption of the active at the site of action. Choosing the right pharmaceutical excipient is a comprehensive task and plays a major role in development or manufacturing process of a formulation, involving studies related to physical properties such as solubility, taste, or stability and chemical properties such as biocompatibility, or toxicity.
[0004] Conventionally used excipients include fillers, binders, disintegrants, and lubricants amongst many others. Polymeric excipients, such as poloxamers, polyethylene glycol, polyvinyl pyrrolidone etc., are most commonly used in drug formulation, however most of them are synthetically produced. These synthetic polymers are expensive. Some of the excipients may show incompatibility with other formulating ingredients, lack desirable physical and mechanical properties, or have high toxicity. Natural polymers are alternative excipients that are safe, biocompatible, readily available, economical and biodegradable. Some of the natural polymer excipients that have been incorporated in formulations in the past
include starch, cellulose, and guar gum. However, there is scope for alternative natural polymer excipients.
[0005] The inventors of the present disclosure provide new pharmaceutical compositions comprising novel natural polymer excipients.
OBJECTS OF THE INVENTION
[0006] An object of the present disclosure is to provide a pharmaceutical
composition comprising a pharmaceutically active component and a natural
excipient.
[0007] An object of the present disclosure is to provide a pharmaceutical
composition comprising a pharmaceutically active component and an
excipient of lyophilized pumpkin seed mucilage.
[0008] Another object of the present disclosure is to provide a process of
preparation of the lyophilized pumpkin seed mucilage.
SUMMARY OF THE INVENTION
[0009] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in Detailed Description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
[0010] In an aspect, the present disclosure provides a pharmaceutical composition comprising a pharmaceutically active component and an excipient, lyophilized pumpkin seed mucilage.
[0011] In an embodiment, the present disclosure provides a pharmaceutical composition comprising a pharmaceutically active component and an excipient, lyophilized pumpkin seed mucilage; wherein the lyophilized pumpkin seed mucilage may be present in a weight percentage range of about 10% to about 20% w/w of the composition.
[0012] In an embodiment, the composition may comprise the pharmaceutically
active component in a weight percentage range of about 5% to about 25% w/w of
the composition.
[0013] In an aspect, the present disclosure provides a pharmaceutical formulation
comprising a pharmaceutically active component, lyophilized pumpkin seed
mucilage, and one or more pharmaceutically acceptable additives.
[0014] In an aspect, the lyophilized pumpkin seed mucilage as recited above, is
prepared by a process comprising the steps of:
(a) weighing and drying pumpkin seeds in an oven at about 100° C; (b)
grinding the seeds of step (a) to obtain a powder; (c) defatting the powder
using petroleum ether in a Soxhlet apparatus to give a defatted powder and
dissolving the defatted powder in water to give a solution; (d) filtering the
solution through a muslin cloth and adding acetone to precipitate pumpkin
seed mucilage; and (e) lyophilizing the pumpkin seed mucilage to give the
lyophilized pumpkin seed mucilage.
[0015] In an aspect, the present disclosure provides use of lyophilized pumpkin
seed mucilage as an excipient for preparation of pharmaceutical composition or
formulation.
[0016] Other aspects of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learnt by the practice of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.
Figure 1 provides the FTIR spectrum of the lyophilized pumpkin seed mucilage obtained by the process as per an embodiment of the present disclosure.
Figure 2 provides the % drug release of pharmaceutically active ingredient (captopril) with time from the formulations F1-F7, as per an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0018] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
[0019] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply. [0020] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0021] In some embodiments, numbers have been used for quantifying weights, percentages, ratios, and so forth, to describe and claim certain embodiments of the invention and are to be understood as being modified in some instances by the term "about." Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can
embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements. [0022] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[0023] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. [0024] Unless the context requires otherwise, throughout the specification which follow, the word "comprise" and variations thereof, such as, "comprises" and "comprising" are to be construed in an open, inclusive sense that is as "including, but not limited to."
[0025] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. [0026] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as
[0027] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified.
[0028] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[0029] It should also be appreciated that the present disclosure can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention. [0030] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments. [0031] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[0032] As used herein, the term 'excipient' refers to pharmaceutically inactive compounds that are present along with the active, that enable it to be manufactured into a composition or formulation by imparting varying
[0033] As used herein, the term 'mucilage' refers to viscous secretion or gelatinous substance obtained from seeds of pumpkin.
[0034] As used herein, the term 'lyophilized' refers to the pumpkin seed mucilage that is dried and dehydrated to remove bound water by freeze drying. [0035] Pharmaceutical actives are seldom administered independently and are usually accompanied by a host of synthetic excipients. Aspects of the present disclosure provide a novel pharmaceutical excipient obtained from bio-waste pumpkin seeds as a natural polymer alternative to excipients well-known in the art.
[0036] In an embodiment, the present disclosure provides a pharmaceutical composition comprising a pharmaceutically active component and an excipient, lyophilized pumpkin seed mucilage.
[0037] In an embodiment, the present disclosure provides a pharmaceutical composition comprising a pharmaceutically active component and an excipient, lyophilized pumpkin seed mucilage; wherein the lyophilized pumpkin seed mucilage may be present in a weight percentage range of about 10% to about 20% w/w.
[0038] In an embodiment, the composition may comprise the pharmaceutically active component in a weight percentage range of about 5% to about 25% w/w of the composition, preferably the weight percentage range of about 10% to about 20%) w/w of the composition.
[0039] In an embodiment, the pharmaceutically active component may be a hydrophilic drug or a lyophilic drug. In an embodiment, the pharmaceutically active component may be of low solubility, high solubility, moderate solubility or intermediate solubility.
[0040] In an embodiment, the pharmaceutically active component may be selected from one or more of group consisting of: anti-epileptics, ace-inhibitors, anti-Alzheimer's agents, anti-anginal drugs, anti-arrhythmias, anti-asthmatics, anti-cholesterolemics, analgesics, anesthetics, anti-convulsants, anti-depressants, anti¬diabetic agents, anti-diarrhea preparations, antidotes, anti-emetics, anti-
anti-manics, anti-migraines, anti-nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti-viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, anti-uricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic anti-infective agents, anti-neoplasties, anti-parkinsonian agents, anti-rheumatic agents, anxiolytics, anti-psychotics, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, bronchodilators, cardiovascular agents, central nervous system stimulates, cholinesterase inhibitors, contraceptives, decongestants, dietary supplements, dopamine receptor agonists, endometriosis management agents, enzymes, erectile dysfunction agents, fertility agents, gastrointestinal agents, H2-antagonists, homeopathic remedies, hormones, hypercalcemia and hypocalcemia management agents, immunomodulators, immunosuppressives, migraine preparations, motion sickness treatments, muscle relaxants, non-steroidal anti¬inflammatories (NSAID's), obesity management agents, osteoporosis preparations, oxytocics, parasympatholytics, parasympathomimetics, prostaglandins, psychotherapeutic agents, respiratory agents, sedatives, serotonin 5-HT3 receptor antagonists, smoking cessation aids, sympatholytics, tremor preparations, urinary tract agents, vasodilators, laxatives, antacids, ion exchange resins, anti-pyretics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, psycho-tropics, stimulants, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, anti-tumor drugs, anti-coagulants, anti-thrombotic drugs, hypnotics, neuromuscular drugs, hyper- and hypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics, anti-spasmodics, anti-obesity drugs, erythropoietic drugs, anti-asthmatics, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof.
[0041] In an embodiment, the active may be captopril, propranolol, tramadol, or diclofenac sodium. [0042] The lyophilized pumpkin seed mucilage has wide ranging properties when
[0043] In an embodiment, the mucilage can perform as a binder, a film former, a
mucoadhesive agent, a release modifier, or combinations thereof.
[0044] In some embodiments, the mucilage may be employed as a dry binder or a
wet binder. In an embodiment, the mucilage can be used alone or in combination
with other binders.
[0045] In some embodiments, the mucilage may also be used for forming a film
or coating for formulations such as tablets. In an embodiment, the mucilage can be
used alone or in combination with other film forming agents.
[0046] In some embodiments, the mucilage may perform as an adhesive to mucus,
mucosal membranes or mucosal surfaces in a subject. The mucilage performs like
an adhesive upon hydration targeting the active to the site of action. In an
embodiment, the mucilage can be used alone or in combination with other
mucoadhesive polymers.
[0047] In some embodiments, the mucilage may act as a release modifier that
controls the release of the active from the composition and maintains its
concentration at the site of action. In an embodiment, the mucilage can be used
alone or in combination with other release modifying polymers.
[0048] In an embodiment, the present disclosure provides a pharmaceutical
formulation comprising a pharmaceutically active component, lyophilized
pumpkin seed mucilage, and one or more pharmaceutically acceptable additives.
[0049] In an embodiment, the pharmaceutically acceptable additives may be
selected from disintegrant, buffer, coloring agent, flavoring agent, preservative,
stabilizer, solvent, lubricant, or combinations thereof.
[0050] In an embodiment, the pharmaceutically acceptable additives may be
selected from the group comprising of sucrose, dextrin, saccharin, aspartame,
sorbitol, mannitol, lactose, phosphate buffer, talc, magnesium stearate, organic
dyes, water, methanol, ethanol, starch, methylcellulose, crospovidone, oil, or
combinations thereof. However, a person skilled in the art would appreciate that
any other additive(s) can be utilized to serve the intended purpose without
departing from the scope and spirit of the invention.
[0051] In an embodiment, the formulation may be in solid, liquid or semi-solid forms. In an embodiment, the formulation may be in the form of a tablet, capsule, powder, granules, solution, aerosol, pill, sachet, film, lozenge, suspension, microemulsion, cream, gel, lotion, emulsion or syrup.
[0052] In an embodiment, the formulation may be a sustained release, immediate release, controlled release or targeted release formulation. In an embodiment, the formulation may be administered orally, transdermally, intravenously, subcutaneously, parenterally, topically, rectally, or combinations thereof. [0053] In an embodiment, the pumpkin seed mucilage is safe, biocompatible, and non-toxic. The mucilage is obtained from a natural source which is readily available making it economical and is also biodegradable. Further, pumpkin seeds are considered a bio-waste, the present disclosure provides a suitable means of utilizing the seeds in a pharmaceutical industry thereby reducing the ecological burden. The mucilage may be used for large scale industrial manufacturing. [0054] In an embodiment, the mucilage when consumed in defined amounts does not possess any adverse short term or long term side-effects. [0055] In an embodiment, the lyophilized pumpkin seed mucilage as recited above, is prepared by a process comprising the steps of:
(a) weighing and drying pumpkin seeds in an oven at about 100° C; (b)
grinding the seeds of step (a) to obtain a powder; (c) defatting the powder
using petroleum ether in a Soxhlet apparatus to give a defatted powder and
dissolving the defatted powder in water to give a solution; (d) filtering the
solution through a muslin cloth and adding acetone to precipitate pumpkin
seed mucilage; and (e) lyophilizing the pumpkin seed mucilage to give the
lyophilized pumpkin seed mucilage.
[0056] In an embodiment, the seeds may be dried in the oven for about 10 to
about 30 minutes, preferably for about 15 to about 20 minutes. In an embodiment,
the powder may be sieved before defatting.
[0057] In an embodiment, the solution obtained from step (c) may be stirred and kept overnight before filtering. In an embodiment, amount of acetone added to the solution may be enough to precipitate all of the mucilage. In an embodiment, after
adding acetone to the solution for precipitation it may be placed in a separating
funnel, wherein the mucilage precipitates out in the acetone solution and can be
easily separated from the funnel.
[0058] In an embodiment, the pumpkin seed is lyophilized by freeze drying in a
freeze dryer.
[0059] In an embodiment, the present disclosure provides a process of preparing a
pharmaceutical formulation comprising a pharmaceutically active component,
lyophilized pumpkin seed mucilage, and one or more pharmaceutically acceptable
additives, wherein the pharmaceutically active component, the mucilage, and the
additives are mixed together to give the formulation.
[0060] In some embodiments, the formulation may be compressed to form a tablet
formulation.
[0061] In an embodiment, the present disclosure provides use of lyophilized
pumpkin seed mucilage as an excipient for preparation of pharmaceutical
composition or formulation.
[0062] While the foregoing describes various embodiments of the disclosure,
other and further embodiments of the disclosure may be devised without departing
from the basic scope thereof. The scope of the invention is determined by the
claims that follow. The invention is not limited to the described embodiments,
versions or examples, which are included to enable a person having ordinary skill
in the art to make and use the invention when combined with information and
knowledge available to the person having ordinary skill in the art.
EXAMPLES
[0063] The disclosure will now be illustrated with working examples, which is
intended to illustrate the working of disclosure and not intended to take
restrictively to imply any limitations on the scope of the present disclosure.
Although methods and materials similar or equivalent to those described herein
can be used in the practice of the disclosed methods and compositions, the
exemplary methods, devices and materials are described herein. It is to be
understood that this disclosure is not limited to particular methods, and
experimental conditions described, as such methods and conditions may vary.
[0064] MATERIALS: The pumpkin seeds were obtained from a local market of Patiala. All other chemicals used for the purposes were obtained from Loba chemie, Mumbai, India.
EXAMPLE 1: Preparation of lyophilized pumpkin seed mucilage [0065] Weighed 50 gms of pumpkin seeds and dried in an oven at 100° C for around 15-20 minutes. This was followed by grinding the dried seeds to make a powder. This powder was then defatted in petroleum ether (500 mL) using Soxhlet apparatus at a temperature of about 60° C for around 6 hours. Defatted powder was mixed with 150 mL of distilled water, stirred for 2 hours and kept overnight before filtering. Filtering was performed with a muslin cloth and to the filtrate excess amount of acetone (100-200 mL) was added and then transferred to a separating funnel which was kept undisturbed for 1-2 hours. The mucilage got precipitated and the precipitated mucilage was lyophilized by freeze-drying in a freeze dryer overnight. The yield of lyophilized pumpkin seed mucilage obtained was 15%.
EXAMPLE 2: Characterization of lyophilized pumpkin seed mucilage [0066] The physical and physiochemical parameters of the lyophilized pumpkin seed mucilage were determined and have been tabulated in Table No. 1 and Table No. 2 below. The FTIR spectrum of the mucilage has been provided in Figure 1. Table No. 1: Physical parameters of lyophilized pumpkin seed mucilage
Physical Parameters Lyophilized Pumpkin Seeds Mucilage
Bulk Density (g/ml) 0.18
Tapped Density (g/ml) 0.23
Hausner's Ratio 1.27
Carr' s Index 21.7
Angle of Repose 24.6
Table No. 2: Physicochemical parameters of lyophilized pumpkin seed
mucilage
S.No. Property Observation
1. Color White
2. Odor Pleasant odor
3. Taste Mucilaginous
4. Solubility Forms colloidal solution in water and is insoluble in ethanol and acetone
5. %yield 15
6. %Loss on drying 10
7. pH (by digital pH meter) 6.2
8. Viscosity (cps) 353
9. Test for carbohydrates (molisch test) +ve
10. Test for reducing sugars (fehling's solution) +ve
11. Test for tannins (ferric chloride test) - ve
12. Test for glycosides - ve
13. Test for starch -ve
14. Test for terpenoids -ve
15. Test for flavonoids (shinoda test) +ve
16. Test for saponins (form test) -ve
17. Test for alkaloids (mayer test) -ve
18. Test for mucilage (ruthenium test) +ve
19. Mucilage + methylene blue Deep blue (+)
20. Mucilage + aqueous KOH Swell (+)
21. Test for chlorides (silver) -ve
EXAMPLE 3: Formulation preparation
[0067] Tablet formulations were prepared by direct compression. The pharmaceutical active chosen was captopril and the tablet formulations F1-F7 were prepared as per Table No. 3 below. Three formulations F1-F3 comprising varying amount of lyophilized pumpkin seed mucilage were prepared while three comparative formulations F4-F6 comprising polymer excipient hydroxypropylmethyl cellulose were prepared. F7 formulation comprises Pumpkin seed mucilage and UPMC in a ratio of 1:1.
Table No. 3: Components for formulation preparation
Components Fl F2 F3 F4 F5 F6 F7
Captopril(mg) 50 50 50 50 50 50 50
Mucilage(mg) 20 30 40 20
HPMCK15(mg) 20 30 40 20
Talc(mg) 2 2 2 2 2 2 2
Mg stearate(mg) 5 5 5 5 5 5 5
Mannitol(mg) 123 113 103 123 113 103 103
Total (mg) 200 200 200 200 200 200 200
[0068] EXAMPLE 4: In vitro drug release profile of the formulation [0069] In vitro drug release test was carried out for the formulations of Table No. 3 above, in dissolution test apparatus USP Type II in phosphate buffer (pH 7.4) as dissolution test medium at temperature 37°C at 75 rpm. Samples for drug release were withdrawn at different time period intervals of 1, 2, 3, 4 and 5 hrs and
analyzed using UV spectrophotometer. Figure 2 provides the % drug release profile of the seven formulations. Formulation Fl, F2 and F3 comprising pumpkin seed mucilage showed sustained drug release which was comparable with that of formulations F5 and F6 comprising FtPMC. Formulation F7 comprising Pumpkin seed mucilage and FtPMC (1:1) showed maximum release of 40% in 5 hrs. [0070] From the foregoing, it will be appreciated that, although specific embodiments of the invention have been described herein merely for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention and should not be construed so as to limit the scope of the invention or the appended claims in any way.
ADVANTAGES OF THE PRESENT INVENTION
[0071] The present disclosure provides a pharmaceutical composition comprising a pharmaceutically active component and lyophilized pumpkin seed mucilage wherein the mucilage is a multi-functional excipient.
[0072] The present disclosure provides an excipient that is economical, readily available, biodegradable, biocompatible and non-toxic.
We Claim:
1. A pharmaceutical composition comprising a pharmaceutically active
component and an excipient, lyophilized pumpkin seed mucilage.
2. The composition as claimed in claim 1, wherein the lyophilized pumpkin seed mucilage is present in a weight percentage range of 10% to 20% of the composition.
3. The composition as claimed in claim 1, wherein the composition comprises the pharmaceutically active component in a weight percentage range of 5% to 25% of the composition.
4. The composition as claimed in claim 1, wherein the pharmaceutically active component may be selected from one or more of group consisting of: anti-epileptics, ace-inhibitors, anti-Alzheimer's agents, anti-anginal drugs, anti-arrhythmias, anti-asthmatics, anti-cholesterolemics, analgesics, anesthetics, anti¬convulsants, anti-depressants, anti-diabetic agents, anti-diarrhea preparations, antidotes, anti-emetics, anti-histamines, anti-hypertensive drugs, anti¬inflammatory agents, anti-lipid agents, anti-manics, anti-migraines, anti-nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti¬viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, anti-uricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic anti-infective agents, anti-neoplasties, anti-parkinsonian agents, anti-rheumatic agents, anxiolytics, anti-psychotics, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, bronchodilators, cardiovascular agents, central nervous system stimulates, cholinesterase inhibitors, contraceptives, decongestants, dietary supplements, dopamine receptor agonists, endometriosis management agents, enzymes, erectile dysfunction agents, fertility agents, gastrointestinal agents, H2-antagonists, homeopathic remedies, hormones, hypercalcemia and hypocalcemia management agents, immunomodulators, immunosuppressives, migraine preparations, motion sickness treatments, muscle relaxants, non-steroidal anti-inflammatories (NSAID's), obesity management agents, osteoporosis preparations, oxytocics,
parasympatholytics, parasympathomimetics, prostaglandins, psychotherapeutic agents, respiratory agents, sedatives, serotonin 5-HT3 receptor antagonists, smoking cessation aids, sympatholytics, tremor preparations, urinary tract agents, vasodilators, laxatives, antacids, ion exchange resins, anti-pyretics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti¬inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, psycho-tropics, stimulants, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, anti-tumor drugs, anti-coagulants, anti-thrombotic drugs, hypnotics, neuromuscular drugs, hyper-and hypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics, anti-spasmodics, anti-obesity drugs, erythropoietic drugs, anti-asthmatics, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof.
5. The composition as claimed in claim 1, wherein the pharmaceutically active component may be selected from captopril, propranolol, tramadol, or diclofenac sodium.
6. The composition as claimed in claim 1, wherein the mucilage can perform as a binder, a film former, a mucoadhesive agent, a release modifier, or combinations thereof.
7. The composition as claimed in claim 1, wherein the lyophilized pumpkin seed mucilage is prepared by a process comprises the steps of:
(a) weighing and drying pumpkin seeds in an oven at 100° C; (b) grinding the seeds of step (a) to obtain a powder; (c) defatting the powder using petroleum ether in a Soxhlet apparatus to give a defatted powder and dissolving the defatted powder in water to give a solution; (d) filtering the solution through a muslin cloth and adding acetone to precipitate pumpkin seed mucilage; and (e) lyophilizing the pumpkin seed mucilage to give the lyophilized pumpkin seed mucilage.
8. A pharmaceutical formulation comprising a pharmaceutically active
component, lyophilized pumpkin seed mucilage, and one or more
pharmaceutically acceptable additives.
9. The formulation as claimed in claim 8, wherein the pharmaceutically acceptable additives are selected from disintegrant, buffer, coloring agent, flavoring agent, preservative, stabilizer, solvent, lubricant, or combinations thereof.
| # | Name | Date |
|---|---|---|
| 1 | 202111031237-STATEMENT OF UNDERTAKING (FORM 3) [12-07-2021(online)].pdf | 2021-07-12 |
| 2 | 202111031237-POWER OF AUTHORITY [12-07-2021(online)].pdf | 2021-07-12 |
| 3 | 202111031237-FORM FOR STARTUP [12-07-2021(online)].pdf | 2021-07-12 |
| 4 | 202111031237-FORM FOR SMALL ENTITY(FORM-28) [12-07-2021(online)].pdf | 2021-07-12 |
| 5 | 202111031237-FORM 1 [12-07-2021(online)].pdf | 2021-07-12 |
| 6 | 202111031237-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [12-07-2021(online)].pdf | 2021-07-12 |
| 7 | 202111031237-EVIDENCE FOR REGISTRATION UNDER SSI [12-07-2021(online)].pdf | 2021-07-12 |
| 8 | 202111031237-DRAWINGS [12-07-2021(online)].pdf | 2021-07-12 |
| 9 | 202111031237-DECLARATION OF INVENTORSHIP (FORM 5) [12-07-2021(online)].pdf | 2021-07-12 |
| 10 | 202111031237-COMPLETE SPECIFICATION [12-07-2021(online)].pdf | 2021-07-12 |
| 11 | 202111031237-Proof of Right [15-07-2021(online)].pdf | 2021-07-15 |
| 12 | 202111031237-FORM 18 [09-05-2023(online)].pdf | 2023-05-09 |