DESC:FIELD OF THE INVENTION
[0001] The present invention relates to inhalable phyto-pharmaceuticals. Specifically, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals. The present invention further relates to a method for preparing a composition comprising microparticles based inhalable phyto-pharmaceuticals.

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] Looking towards today’s scenario of increased environmental pollution, occupational chemicals, noxious particles and tobacco smoke; pulmonary diseases like asthma, chronic in?ammation, chronic obstructive pulmonary disease (COPD), and bronchoconstriction have been the most prevalent worldwide health concern (Mehta et al., 2018). Pulmonary drug administration has been considered as the chief route for delivery of medicament. Pulmonary diseases are usually cured using different synthetic molecules. But, frequent high-dose of these drugs may lead to severe side effects and this juncture demands inhalable formulations that facilitate effective drug delivery to the lower airways with negligible side effects. Natural phytoconstituents or phytoalexin (i.e. plant antibiotics) have shown unique treatment array with minimum side effects and great capability to treat intrapulmonary and extra-pulmonary diseases compared to synthetic drugs. Moreover, the progress of disciplines such as nanotechnology, material science and article engineering allows further improvement of the treatment capability and efficiency. Therefore, phytoconstituents based pharmaceuticals have been preferred which exhibit an exclusive treatment with minimum side e?ects and immense potential to cure pulmonary diseases (Beck-Broichsitter et al., 2012; Patton et al., 2007; Rave et al., 2005).
[0004] There is, therefore, a need to further develop potent and safe inhalable phyto-pharmaceuticals that can overcome deficiencies associated with the known arts.
OBJECTS OF THE INVENTION
[0005] An object of the present invention is to provide inhalable phyto-pharmaceuticals that satisfy the existing needs, as well as others, and generally overcome the deficiencies found in the prior art.
[0006] Another object of the present invention is to provide a composition comprising microparticles based inhalable phyto-pharmaceuticals.
[0007] Yet another object of the present invention is to provide a method of preparation of composition comprising microparticles based inhalable phyto-pharmaceuticals.
[0008] Still another object of the present invention is to provide a composition comprising microparticles based inhalable phyto-pharmaceuticals with optimized parameters.
[0009] Another object of the present invention is to provide a composition comprising microparticles based inhalable phyto-pharmaceuticals and its quality-by-design optimization.

SUMMARY OF THE INVENTION
[0010] The present invention relates to inhalable phyto-pharmaceuticals. Specifically, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals.
[0011] In one aspect, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, comprising herbal extracts of Trigonella foenum-graecum and Alpinia galangal along with a polymer, a surfactant and mannitol.
[0012] In another aspect, the present invention relates to a method for preparing a composition comprising microparticles based inhalable phyto-pharmaceuticals.
[0013] In another aspect, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals prepared by emulsification solvent evaporation technique, followed by freeze drying.
[0014] In yet another aspect, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the herbal extracts are encapsulated into freeze dried inhalable microparticles (FDIMs).
[0015] In yet another aspect, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the freeze dried microparticles are obtained as fine, porous powder having very less bulk density.
[0016] In still another aspect, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the composition is optimized using box-behnken design (BBD) to produce porous FDIMs.
[0017] In still another aspect, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein FDIMs are prepared with reduced particle size and lesser bulk density as required for lung deposition and retention.
[0018] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments

BRIEF DESCRIPTION OF DRAWINGS THE INVENTION
[0019] 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: Contour plot (2D) showing the effect of independent variables on mean diameter (µm) (Y1)
Figure 2: Response surface plot (3D) showing the effect of independent variables on mean diameter (µm) (Y1)
Figure 3: Contour plot (2D) showing the effect of independent variables on bulk density (g/cc) (Y2)
Figure 4: Response surface plot (3D) showing the effect of independent variables on bulk density (g/cc) (Y2)
Figure 5: Contour plot (2D) showing desirability value for optimized FDIMs
Figure 6: Response surface plot (3D) showing desirability value for optimized FDIMs

DETAILED DESCRIPTION
[0020] 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.
[0021] 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.
[0022] 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.
[0023] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention 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 vary depending upon the desired properties sought to be obtained by a particular 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.
[0024] 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.
[0025] 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.”
[0026] 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. 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 indicating any non-claimed element essential to the practice of the invention.
[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 thus fulfilling the written description of all Markush groups used in the appended claims.
[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] 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.
[0033] The present invention relates to inhalable phyto-pharmaceuticals. Specifically, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals.
[0034] In one embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, comprising herbal extracts and a polymer in a specific ratio along with a surfactant and mannitol.
[0035] In another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the herbal extracts and polymer are present in the ratio of 1:2 by weight.
[0036] In another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the herbal extracts are extracts of the herbs Trigonella foenum-graecum and Alpinia galangal.
[0037] In an embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, comprising herbal extracts of Trigonella foenum-graecum and Alpinia galangal, a polymer, a surfactant and mannitol.
[0038] In an embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the herbal extracts of Trigonella foenum-graecum and Alpinia galangal are present in the ratio by weight of 1:2 to 2:1.
[0039] In another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the herbal extracts of Trigonella foenum-graecum and Alpinia galangal are present in equal proportions by weight.
[0040] In an embodiment, the herbal extract of Trigonella foenum-graecum may be obtained from the seeds, leaves, sprouts and shoots of the herb.
[0041] In an embodiment, the herbal extract of Alpinia galangal may be obtained from the roots, leaves, rhizomes, seeds and shoots of the herb.
[0042] In another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the polymer can be selected from Polyvinyl pyrollidone K30 (PVP K30), polyethylene glycol 6000 (PEG 6000), Ethyl cellulose, Methyl cellulose, Polycaprolactone, Polyhydroxybutyrate, Eudragit RS 100, Eudragit RL 100, Carboxymethyl cellulose, Chitosan, Hydroxyl Propyl Methyl Cellulose, Poly-(lactide-co-glycolide) (PLGA), Polylactide (PLA), Gelatin, Guar gum and combinations thereof. In an embodiment of the present invention, the polymer is used for fabrication of the microparticles.
[0043] In a preferred embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the polymer can be selected from Polyvinyl pyrollidone K30 (PVP K30), polyethylene glycol 6000 (PEG 6000) and their combination.
[0044] In an embodiment, the mannitol is present in weight by volume percentage of from about 2 to about 6, preferably 4.616 of the composition.
[0045] In another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein mannitol was added for surface modification with the intention of enhancing aerodynamic property of the microparticles.
[0046] In still another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the surfactant can be selected from Tween 80, Tween 20, Tween 40, Span 20, Span 40, D-a-Tocopherol polyethylene glycol 1000 succinate (TPGS), Poloxamer 407, polyoxyethylene glycerol triricinoleate, cremophor EL, sodium cholate hydroxylated phospholipids/lecithin, miglyol, triacetin and combinations thereof.
[0047] In an embodiment, the surfactant is present in volume by volume percentage of from about 0.5 to about 2.0, preferably 1.5 of the composition.
[0048] In an embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, comprising the herbal extracts and polymer in the ratio of 1:2, the surfactant in a volume by volume percentage of 1.5 and mannitol in a weight by volume percentage of 4.616.
[0049] In another embodiment, the present invention relates to a method for preparing a composition comprising microparticles based inhalable phyto-pharmaceuticals.
[0050] In an embodiment, the present invention relates to a method for preparing a composition comprising microparticles based inhalable phyto-pharmaceuticals by emulsification solvent evaporation technique, followed by freeze drying.
[0051] In still another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals prepared by emulsification solvent evaporation technique, followed by freeze drying.
[0052] In an embodiment, the method for preparing the composition comprising microparticles based inhalable phyto-pharmaceuticals comprises:
(i) dissolving herbal extracts of Trigonella foenum-graecum and Alpinia galangal with mannitol and a surfactant to give an aqueous phase;
(ii) mixing a polymer in an organic solvent to give an organic phase; and
(iii) adding the organic phase with optional stirring to the aqueous phase to produce the composition comprising microparticles based inhalable phyto-pharmaceuticals.
[0053] In another embodiment, the step (iii) is further followed by freeze-drying to give the freeze dried inhalable microparticles (FDIMs).
[0054] In yet another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the herbal extracts are encapsulated into freeze dried inhalable microparticles (FDIMs).
[0055] In still another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein the composition is optimized using box-behnken design (BBD) to produce porous FDIMs. Porous microparticles can be adopted as the drug vehicle due to low density of porous structure which can be absorbed efficiently in a lung surface area to achieve high drug deposition of inhaled drug throughout the lung.
[0056] In another embodiment, the present invention relates to a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein FDIMs are prepared with reduced particle size and lesser bulk density as required for lung deposition and retention.
[0057] In an embodiment, the reduced and finer particle size and bulk density enable deeper penetration into the lungs of a subject.
[0058] In an embodiment, the particle size of is in the range of about 1.0 µm to about 5.0 µm, preferably it is in the range of about 1.0 µm to about 2.0 µm, more preferably it is less than 1.3 µm.
[0059] In an embodiment, the bulk density is in the range of about 0.01 g/cc to about 0.5 g/cc, preferably less than 0.2 g/cc.
[0060] In an embodiment, the subject on which the composition comprising microparticles based inhalable phyto-pharmaceuticals is used may be a mammal including but not limited to humans, rats and monkeys.
[0061] In an embodiment, the composition comprising microparticles based inhalable phyto-pharmaceuticals may be given to a subject undergoing treatment or amelioration of diseases or disorders or dysfunctions related to the pulmonary system. Therefore, the composition is useful in the field of pulmonary therapeutics. Said compositions are potent and safe for use.
[0062] In an embodiment, the composition is effective for pulmonary diseases advantageously including asthma, bronchitis, pleuritic, chronic obstructive pulmonary diseases.
[0063] In an embodiment, the composition comprising microparticles based inhalable phyto-pharmaceuticals is administered alone or in a combination with one or more additional agents.
[0064] In an embodiment, the composition comprising microparticles based inhalable phyto-pharmaceuticals can be formulated with, but not limited to one or more therapeutic agents, vaccines and pharmaceutical actives. The pharmaceutical actives may include antibiotics and corticosteroids. The therapeutical agents may include macromolecules, steroids, antibodies, hormones, bronchodilators and anti-inflammatory agents.
[0065] In an embodiment, the composition comprising microparticles based inhalable phyto-pharmaceuticals is in the form of a powder that may be blended with other known pharmaceuticals or carriers or adjuvants as per the requirement.
[0066] In an embodiment, the composition comprising microparticles based inhalable phyto-pharmaceuticals is administered via inhalation through an inhaler. Specifically the inhaler may be a dry powder inhaler.
[0067] In an embodiment, the dose of the composition may be adjusted based on the subject. The dose may be a single dose or multiple doses based on the dry powder inhaler used, the number of containers in the inhaler and the medically prescribed amount.
[0068] 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.
[0069] The present invention is further explained in the form of following examples. However, it is to be understood that the following examples are merely illustrative and are not to be taken as limitations upon the scope of the invention.
Example 1: Composition of freeze dried inhalable microparticles (FDIMs)
Table 1: Independent and response variables for FDIMs
Independent variables -1 (Low) 0 (Medium) +1 (High)
X1= *Herbal Extract: Polymer (w/w) 1:2 1:3 1:4
X2 = Mannitol (% w/v) 2 4 6
X3 = Surfactant (% v/v) 0.5 1 1.5
Response variables Constraints Importance
Y1 = Mean Diameter (µm) Minimize +++++
Y2 = Bulk Density (g/cc) Minimize +++++
*Trigonella foenum-graecum and Alpinia galangal extracts were taken in equal proportions

The Trigonella foenum-graecum and Alpinia galangal extracts used above were obtained from NJP Healthcare Pvt. Ltd. Valsad, Gujarat.

Table 2. Box-behnken design (BBD) layout for different batches of FDIMs
FDIM Herbal Extract: Polymer (w/w) Mannitol
(% w/v) Surfactant
(% v/v) Mean diameter (µm) Bulk density (g/cc)
1 1:2 2 1 2.1 0.31
2 1:4 2 1 8.1 0.71
3 1:2 6 1 1.8 0.34
4 1:4 6 1 7.6 0.69
5 1:2 4 0.5 2.6 0.35
6 1:4 4 0.5 7.9 0.72
7 1:2 4 1.5 1.2 0.23
8 1:4 4 1.5 7.4 0.70
9 1:3 2 0.5 4.5 0.34
10 1:3 6 0.5 4.1 0.45
11 1:3 2 1.5 3.7 0.39
12 1:3 6 1.5 3.9 0.33
13 1:3 4 1 3.3 0.31
14 1:3 4 1 3.5 0.48
15 1:3 4 1 3.7 0.35
16 1:3 4 1 3.6 0.36
17 1:3 4 1 3.8 0.38

Example 2: Preparation of the freeze dried inhalable Microparticles (FDIMs)
FDIMs were prepared by quasi-emulsification solvent evaporation technique followed by freeze drying. Herbal extracts and mannitol were dissolved in distilled water followed by addition of tween 80. PVP K30 and PEG 6000 were dissolved in ethanol. Organic phase was added slowly to the aqueous phase with continuous magnetic stirring (REMI, India) at 2000 rpm for 30 minutes to produce fine dispersion of microparticles succeeded by freeze drying at - 55oC and 0.5 kPa (vacuum) for 24 hrs (ISIC Make) to generate fine, porous powder having very less density.
Example 3: Evaluation of FDIMs
Mean diameter (Y1)
Mean diameters of FDIMs was determined by optical microscopy using compound microscope (Erma, 23 Tokyo, Japan). All samples were diluted with distilled water before measurement. The particle size measurement was conducted for minimum 300 particles of sample to find out mean particle size. Measurement was executed in triplicate (n = 3) to obtain mean diameter.
Bulk density (Y2)
The bulk density of FDIMs was determined using 10 mL graduated cylinder. 1 gram of FDIMs was poured into the cylinder and bulk density was calculated using the formula:
Eq. 1

Optimization of FDIMs using quality by design (QbD)
On the basis of regression coefficient (R²), F-value and p-value calculated by Design-Expert software (Trial Version 11.1.2.0, Stat-Ease Inc., MN), quadratic model was suggested for Y1 and Y2. The R², F-value and p-value for mean diameter (µm) were 0.9959, 39.56 and < 0.0001 while for bulk density (g/cc), values were 0.9574, 9.29 and 0.0078, respectively. Therefore, second order polynomial model was generated by multiple regression analysis using Design-Expert software.
Eq. (2)
Where, Y denotes observed response variable and ß0 is constant coefficient. ßi, ßii and ßij represents coefficients of linear, quadratic parameter and interaction parameters, respectively. Xi represents average outcome of changing one variable at a time from low to high, polynomial terms Xi2 was employed to assess non-linearity effect of variable Xi, interaction terms XiXj illustrated how the response transforms when two variables Xi and Xj were altered concurrently.
Response surface analysis of mean diameter (µm) (Y1)
Independent factors affecting mean diameter (µm) of FDIMs were herbal extract: polymer (X1) and surfactant (X3) (p < 0.01) which can be elucidated by following polynomial quadratic equation and has been depicted in Figures 1 and 2.
Y1 = 3.58 + 2.91 X1 - 0.125 X2 - 0.363 X3 - 0.05 X1X2 + 0.225 X1X3 + 0.15 X2X3 + 1.02 X12 + 0.297 X22 + 0.17 X32 Eq. (3)
The negative and positive coefficients before independent variables pinpoint negative and positive effect on response variables, respectively (see Figure 1 and Figure 2).
Response surface analysis of bulk density (g/cc) (Y2)
Independent factors affecting bulk density (g/cc) of FDIMs were herbal extract: polymer (X1) and surfactant (X3) (p < 0.01) which can be elucidated by following polynomial quadratic equation and has been depicted in Figures 3 and 4.
Y2 = 0.376 + 0.198 X1 + 0.0075 X2 - 0.0263 X3 - 0.0125 X1X2 + 0.025 X1X3 - 0.0425 X2X3 + 0.1295 X12 + 0.007 X22 - 0.0055 X32
Example 4: Optimized formulation of FDIMs as per Design-expert® 11.1.2.0 software

Table 3. Optimized formulation as per the Design-expert® 11.1.2.0 software
Independent variables Criteria Importance Value D?
X1= *Herbal Extract: Polymer (w/w) In range +++ 1:2
X2 = Mannitol (% w/v) In range +++ 4.616
X3 = Surfactant (% v/v) In range +++ 1.5
Response variables
Y1 = Mean Diameter (µm) Minimize +++++ 1.326
Y2 = Bulk Density (g/cc) Minimize +++++ 0.244 0.977
?Desirability
[0070] Based on the above, it may be noted that the particles have reduced particle size, reduced bulk density and thus the claimed composition can be effectively used for high deposition of inhaled drugs throughout the lungs.
[0071] The foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

ADVANTAGES OF THE PRESENT INVENTION
[0072] The present invention provides a composition comprising microparticles based inhalable phyto-pharmaceuticals that satisfies the existing needs, as well as others, and generally overcomes the deficiencies found in the prior art.
[0073] The present invention provides a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein herbal extracts are extracts of Trigonella foenum-graecum and Alpinia galangal.
[0074] The present invention provides a composition comprising microparticles based inhalable phyto-pharmaceuticals wherein the composition is optimized using box-behnken design (BBD) to produce porous FDIMs.
[0075] The present invention provides a composition comprising microparticles based inhalable phyto-pharmaceuticals, wherein FDIMs are prepared with reduced particle size and lesser bulk density as required for lung deposition and retention.

,CLAIMS:1. A composition comprising microparticles based inhalable phyto-pharmaceuticals, comprising herbal extracts of Trigonella foenum-graecum and Alpinia galangal, a polymer, a surfactant and mannitol.
2. The composition as claimed in claim 1, wherein the herbal extracts of Trigonella foenum-graecum and Alpinia galangal are present in equal proportions by weight.
3. The composition as claimed in claim 1, wherein the herbal extracts and polymer are present in the ratio of 1:2 by weight.
4. The composition as claimed in claim 1, wherein the polymer is selected from Polyvinyl pyrollidone K30 (PVP K30), polyethylene glycol 6000 (PEG 6000), Ethyl cellulose, Methyl cellulose, Polycaprolactone, Polyhydroxybutyrate, Eudragit RS 100, Eudragit RL 100, Carboxymethyl cellulose, Chitosan, Hydroxyl Propyl Methyl Cellulose, Poly-(lactide-co-glycolide) (PLGA), Polylactide (PLA), Gelatin, Guar gum and combinations thereof.
5. The composition as claimed in claim 4, wherein the polymer is selected from Polyvinyl pyrollidone K30 (PVP K30), polyethylene glycol 6000 (PEG 6000) and their combination.
6. The composition as claimed in claim 1, wherein the surfactant is selected from Tween 80, Tween 20, Tween 40, Span 20, Span 40, D-a-Tocopherol polyethylene glycol 1000 succinate (TPGS), Poloxamer 407, polyoxyethylene glycerol triricinoleate, cremophor EL, sodium cholate hydroxylated phospholipids/lecithin, miglyol, triacetin and combinations thereof.
7. The composition as claimed in claim 1, wherein the surfactant is present in volume by volume percentage of 0.5 to 2.0.
8. The composition as claimed in claim 1, wherein the mannitol is present in weight by volume percentage of 2 to 6.
9. The composition as claimed in claim 1, wherein the composition comprising microparticles based inhalable phyto-pharmaceuticals comprises the herbal extracts and polymer in the ratio of 1:2, the surfactant in a volume by volume percentage of 1.5 and mannitol in a weight by volume percentage of 4.616.
10. The composition as claimed in claim 1, wherein the microparticles have reduced particle size and bulk density.
11. A method for preparing a composition comprising microparticles based inhalable phyto-pharmaceuticals comprises:
(i) dissolving herbal extracts of Trigonella foenum-graecum and Alpinia galangal with mannitol and a surfactant to give an aqueous phase;
(ii) mixing a polymer in an organic solvent to give an organic phase; and
(iii) adding the organic phase with stirring to the aqueous phase to produce the composition comprising microparticles based inhalable phyto-pharmaceuticals.
12. The method as claimed in claim 11, wherein the step (iii) is followed by freeze-drying to give the freeze dried inhalable microparticles (FDIMs).
13. The method as claimed in claim 11, wherein the herbal extracts are encapsulated into the freeze-dried inhalable microparticles.