Description:DESCRIPTION:
Field of the invention:
[0001] The present disclosure generally relates to the technical field of pharmaceutical compositions, and in specific, relates to a composition and method that prepares a gastroprotective niosomal syrup by using tradescantia pallida extract to enhance drug efficacy.
Background of the invention:
[0002] Ulcers are lesions in the gastrointestinal mucosa characterized by necrosis, neutrophil infiltration, reduced blood flow, increased oxidative stress, and inflammation. Peptic ulcer (PU) disease is often marked by periodic epigastric pain. This condition is classified based on its anatomical location, including gastric and duodenal ulcers. Patients with ulcers typically experience symptoms such as abdominal discomfort, pain, or nausea, with epigastric pain being the most prevalent symptom for both gastric and duodenal ulcers.
[0003] To treat ulcers, various drugs are used to inhibit or neutralize gastric acid secretion. These include antacids, histamine H2-receptor antagonists, proton pump inhibitors, anticholinergics, and prostaglandins. Among these, selective histamine type 2 receptor antagonists (H2 blockers) are particularly effective in treating gastroesophageal reflux disease (GERD) and duodenal ulcers. H2 receptor antagonists work by binding to the basolateral surface of gastric parietal cells, thereby interfering with gastric acid production and secretion. Common H2 receptor antagonists include cimetidine, ranitidine, nizatidine, and nizatidine.
[0004] Nizatidine, a competitive and reversible inhibitor of histamine at the histamine H2 receptors in gastric parietal cells, is widely used in short-term therapy for GERD and duodenal ulcers. By inhibiting the action of histamine on stomach cells, nizatidine reduces stomach acid production. Unlike some other medications, nizatidine does not exhibit antiandrogenic action. Full-dose therapy with nizatidine usually lasts no longer than eight weeks, although reduced doses have been shown to be effective as maintenance therapy following the healing of active duodenal ulcers.
[0005] The typical adult dose of nizatidine varies depending on the condition being treated. For stomach and intestinal ulcers, the usual dose is 300 mg daily, either as 150 mg twice a day or 300 mg at bedtime. The oral bioavailability of nizatidine exceeds 70%, with peak plasma concentrations occurring between 0.5 to 3 hours after administration. The elimination half-life of nizatidine is 1 to 2 hours, with plasma clearance between 40 to 60 L/h and a volume of distribution of 0.8 to 1.5 L/kg. Due to its short half-life and rapid clearance, nizatidine exhibits dose proportionality over the recommended dose range. More than 90% of an orally administered dose of nizatidine is excreted in the urine within 12 hours, with approximately 60% excreted as an unchanged drug. Renal clearance is about 500 mL/min, indicating excretion via active tubular secretion, while less than 6% is eliminated in the feces.
[0006] Ulcers typically heal within four weeks, although up to eight weeks of treatment may be necessary. Long-term use of nizatidine has been associated with severe adverse effects, including chest pain, confusion, fever, signs of anemia, gout, infections, and liver problems. Nizatidine is available in the market in oral unit dosage forms, such as tablets, capsules, and solutions. According to the Biopharmaceutics Classification System (BCS), nizatidine belongs to Class III, indicating high solubility but low membrane permeability. Despite its high aqueous solubility, the current research aims to explore the suitability of niosomes as a nanocarrier to enhance the permeation of nizatidine. This approach seeks to improve the drug's bioavailability and therapeutic efficacy.
[0007] In existing technology, a novel nitrile glycoside is known. A process for the isolation of a novel nitrile glycoside of Formula I below named NIAZIRIDIN and its derivatives and analogues by bioactivity-guided fractionation from the pods of Moringa oleifera. The biomolecule also enhances the absorption of drugs, vitamins, and nutrients through the gastro-intestinal membrane increasing their bio-availability. However, the novel nitrile glycoside does not provide drug efficiency.
[0008] Therefore, there is a need for a composition and method that prepares a gastroprotective niosomal syrup for enhancing the drug efficiency. There is also a need for a method that prepares the gastroprotective niosomal syrup for enhancing gastroprotective activity by encountering the ulcer score caused by histamine-induced ulcers. Further, there is also a need for the method that prepares the gastroprotective niosomal syrup for providing significant acid-neutralizing capacity and antiulcerogenic and antisecretory activity.
Objectives of the invention:
[0009] The primary objective of the invention is to provide a gastroprotective niosomal syrup by using tradescantia pallida extract to enhance drug efficacy.
[0010] Another objective of the invention is to provide the gastroprotective niosomal syrup for providing significant acid-neutralizing capacity and antiulcerogenic and antisecretory activity.
[0011] The other objective of the invention is to provide the gastroprotective niosomal syrup for enhancing gastroprotective activity by encountering the ulcer score caused by histamine-induced ulcers.
[0012] The other objective of the invention is to provide the gastroprotective niosomal syrup demonstrating a reduction in ulcer formation, confirming the efficacy of the treatment.
[0013] Yet another objective of the invention is to provide the gastroprotective niosomal syrup for enhancing the drug’s permeation efficacy.
[0014] Further objective of the invention is to provide the gastroprotective niosomal syrup for enhancing drug efficiency.
Summary of the invention:
[0015] The present disclosure proposes a composition and method for preparing a gastroprotective niosomal syrup using tradescantia pallida extract. The following presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview. It is not intended to identify key/critical elements or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.
[0016] In order to overcome the above deficiencies of the prior art, the present disclosure is to solve the technical problem to provide a method that prepares a gastroprotective niosomal syrup by using tradescantia pallida extract to enhance drug efficacy.
[0017] According to an aspect, the invention provides a composition for preparing a gastroprotective niosomal syrup using tradescantia pallida extract. In one embodiment herein, the gastroprotective niosomal syrup comprises 4 to 8 weight percentage of Nizatidine niosomes, 79 to 83 weight percentage of sucrose and 10 to 14 weight percentage of purified water. In one embodiment herein, the Nizatidine niosomes comprises 1.7 to 1.9 weight percentage of Nizatidine, 2.6 to 2.8 weight percentage of a fortified product, 1.7 to 1.9 weight percentage of a cholesterol, 3.5 to 3.7 weight percentage of a Span 60 and 89 to 91 weight percentage of a phosphate buffer solution.
[0018] The gastroprotective niosomal syrup demonstrated significant acid-neutralizing capacity, along with notable antiulcerogenic and antisecretory activity. The gastroprotective niosomal syrup is encapsulated in at least one of a syrup, a tablet and a capsule.
[0019] In one embodiment herein, the fortified product is prepared by dissolving small segments of sliced Trandescantia pallida leaves in cow urine, thereby enhancing the growth of the trandescantia pallida. In addition, the Span 60 and the cholesterol are formulated at a ratio of at least 2:1. Particularly, a particle size of the gastroprotective niosomal syrup varies between 237.1 nm and 351.1 nm.
[0020] According to another aspect, the invention provides a method for preparing the gastroprotective niosomal syrup. At one step, Trandescantia pallida leaves are collected and sliced them into small segments. At one step, the small segments are dissolved in cow urine for preparing a fortified product, thereby enhancing the growth of the trandescantia pallida. At one step, Nizatidine is dissolved in a phosphate buffer solution to obtain a Nizatidine mixture. At one step, the Nizatidine mixture is mixed with the fortified product to form a first solution. At one step, a second solution is injected into the Nizatidine mixture is mixed with the fortified product to form a first solution.
[0021] At one step, a second solution is injected into the first solution to obtain a Nizatidine niosomes. Particularly, the second solution is prepared using cholesterol, Span 60 and an ethanol. At one step, 66.7 gm of sucrose is mixed with 10 ml of purified water for preparing a third solution, thereby blending 5 ml of Nizatidine niosomes into the third solution to obtain the gastroprotective niosomal syrup. The gastroprotective niosomal syrup demonstrated a reduction in ulcer formation, confirming the efficacy of the treatment.
[0022] Further, objects and advantages of the present invention will be apparent from a study of the following portion of the specification, the claims, and the attached drawings.
Detailed description of drawings:
[0023] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate an embodiment of the invention, and, together with the description, explain the principles of the invention.
[0024] FIG. 1 illustrates a block diagram of ingredients of a composition used for preparing a gastroprotective niosomal syrup, in accordance to an exemplary embodiment of the invention.
[0025] FIG. 2 illustrates a flowchart of a method for preparing a gastroprotective niosomal syrup, in accordance to an exemplary embodiment of the invention.
[0026] FIGs. 3A-3B illustrate graphical representations for the particle size distribution of N1 and N2 for gastroprotective niosomal syrup, in accordance to an exemplary embodiment of the invention.
[0027] FIGs. 3C-3D illustrate graphical representations for zeta potential distribution of N1 and N2 for gastroprotective niosomal syrup, in accordance to an exemplary embodiment of the invention.
[0028] FIG. 4A illustrates a scanning electron microscope (SEM) of N1 for gastroprotective niosomal syrup, in accordance to an exemplary embodiment of the invention.
[0029] FIG. 4B illustrates a scanning electron microscope (SEM) of N2 for gastroprotective niosomal syrup, in accordance to an exemplary embodiment of the invention.
[0030] FIGs. 5A-5D illustrate pictorial representations of four groups of rats, each of which likely receiving a different treatment, in accordance to an example embodiment of the invention.
[0031] FIGs. 6A-6D illustrate pictorial representations of stomach histopathology of rats, which are treated with Nizatidine and optimized formulation, in accordance to an example embodiment of the invention.
Detailed invention disclosure:
[0032] Various embodiments of the present invention will be described in reference to the accompanying drawings. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps.
[0033] The present disclosure has been made with a view towards solving the problem with the prior art described above, and it is an object of the present invention to provide a method that prepares a gastroprotective niosomal syrup by using tradescantia pallida extract to enhance drug efficacy.
[0034] The use of cow urine as a pharmaceutical adjuvant is a sound decision due to its numerous medicinal and nutritional properties. Highly concentrated cow urine as a pharmaceutical additive significantly increases solubility and drug release from oral formulations. Nowadays, plant-based medicine is used as adjuvant therapy alongside allopathic drugs to enhance their pharmacodynamic properties, which can exhibit toxicity at higher doses.
[0035] According to an exemplary embodiment of the invention, FIG. 1 refers to a block diagram of ingredients of a composition used for preparing a gastroprotective niosomal syrup 100. In one embodiment herein, the composition for preparing the gastroprotective niosomal syrup 100 comprises 4 to 8 weight percentage of Nizatidine niosomes 10, 79 to 83 weight percentage of sucrose 12 and 10 to 14 weight percentage of purified water 14.
[0036] In one embodiment herein, the Nizatidine niosomes 10 comprises multiple components such as 1.7 to 1.9 weight percentage of Nizatidine 102, 2.6 to 2.8 weight percentage of a fortified product 104, 1.7 to 1.9 weight percentage of a cholesterol 106, 3.5 to 3.7 weight percentage of a Span 60 108 and 89 to 91 weight percentage of a phosphate buffer solution 110. In addition, the gastroprotective niosomal syrup 100 is encapsulated in at least one of a syrup, a tablet and a capsule.
[0037] In one embodiment herein, the fortified product 104 is prepared by dissolving small segments of sliced Trandescantia pallida leaves in cow urine, thereby enhancing the growth of the trandescantia pallida. In addition, the Span 60 108 and the cholesterol 106 are formulated at a ratio of at least 2:1. Particularly, a particle size of the gastroprotective niosomal syrup 100 varies between 237.1 nm and 351.1 nm. The gastroprotective niosomal syrup 100 demonstrated significant acid-neutralizing capacity, along with notable antiulcerogenic and antisecretory activity.
[0038] According to another embodiment of the invention, FIG. 2 refers to a flowchart 200 of a method for preparing the gastroprotective niosomal syrup 100. At step 202, Trandescantia pallida leaves are collected and sliced them into small segments. At step 204, the small segments are dissolved in cow urine for preparing the fortified product 104, thereby enhancing the growth of the trandescantia pallida. At step 206, Nizatidine 102 is dissolved in a phosphate buffer solution 110 to obtain a Nizatidine mixture. At step 208, the Nizatidine mixture is mixed with the fortified product 104 to form a first solution.
[0039] At step 210, a second solution is injected into the first solution to obtain a Nizatidine niosomes 10. Particularly, the second solution is prepared using the cholesterol 106, the Span 60 108 and an ethanol. At step 212, 66.7 gm of sucrose 12 is mixed with 10 ml of purified water 14 for preparing a third solution, thereby blending 5 ml of Nizatidine niosomes into the third solution to obtain the gastroprotective niosomal syrup 100. Additionally, the gastroprotective niosomal syrup 100 demonstrating a reduction in ulcer formation, confirming the efficacy of the treatment.
[0040] In one embodiment herein, the composition for preparing a gastroprotective niosomal syrup 100 comprises 6 weight percentage of the Nizatidine niosomes 10, 81 weight percentage of the sucrose 12 and 12 weight percentage of the purified water 14. In one embodiment herein, a composition for formulating Nizatidine niosomes 10 comprises multiple components such as 1.8 weight percentage of Nizatidine 102, 2.7 weight percentage of a fortified product 104, 1.8 weight percentage of a cholesterol 106, 3.6 weight percentage of a Span 60 108 and 90 weight percentage of a phosphate buffer solution 110. The Nizatidine niosomes 10 are mixed with the sucrose 12 and purified water 14 to obtain a gastroprotective niosomal syrup 100.
[0041] Table 1:
Ingredients N1 N2
Nizatidine 100 mg 150 mg
Tradescantia pallida in fresh cow urine 150 mg 100 mg
Cholesterol 100 mg 100 mg
Span 60 200 mg 200 mg
Phosphate buffer 7.4 5 ml 5 ml

[0042] Table 1 depicts the multiple components used to formulate the Nizatidine niosomes in two different types (N1 and N2). In one embodiment herein, the multiple components include the Nizatidine, Tradescantia pallida in fresh cow urine, the cholesterol, a Span 60 and the phosphate buffer with a pH of 7.4.
[0043] In one example embodiment herein, N1 type Nizatidine niosomes comprise 100 mg of Nizatidine 102, 150 mg of the Tradescantia pallida in fresh cow urine, 100 mg of the cholesterol 106, 200 mg of the Span 60 108 and 15 ml of the phosphate buffer solution 110. In one example embodiment herein, N2 type Nizatidine niosomes comprise 150 mg of Nizatidine 102, 100 mg of the Tradescantia pallida in fresh cow urine, 100 mg of the cholesterol 106, 200 mg of the Span 60 108 and 5 ml of the phosphate buffer solution 110.
[0044] Table 2:
Formulations Particle size (nm) PDI Zeta potential (mV) Entrapment efficiency (%)
N1 351.1 0.548 - 10.6 52.26 ± 1.8
N2 237.1 0.609 - 33.5 56.83 ± 1.4

[0045] Table 2 depicts characterizations of two different formulation of the Nizatidine niosomes, labelled as N1 and N2. The data includes measurements of particle size, polydispersity index (PDI), zeta potential, and entrapment efficiency for each formulation. In one embodiment herein, the average particle size of the N1 and N2 is 351.1 and 237.1 nm, respectively. The polydispersity index (PDI) of the N1 and N2 is 0.548 and 0.609, respectively. In addition, the N1 indicating the size distribution of the particles and the N2 indicating a slightly broader size distribution compared to the N1.
[0046] The zeta potential of the N1 is – 10.6 millivolts (mV), which provides an indication of the stability of the niosomes. The zeta potential of the N2 is –33.5 mV, suggesting a higher stability compared to N1 due to the larger negative charge. The entrapment efficiency of the N1 is 52.26 % with a standard deviation of ± 1.8%, indicating the percentage of Nizatidine successfully encapsulated within the niosomes. The entrapment efficiency of the N2 is 56.83 % with a standard deviation of ± 1.4%, showing a higher encapsulation rate compared to N1.
[0047] In one embodiment herein, the composition of the vesicular membrane influences the size of the niosomes. Span 60, a non-ionic surfactant with an HLB value of 4.7, has a large hydrophobic moiety and low water solubility. Cholesterol is incorporated into the formulation to enhance the stability of the vesicular bilayers. In these formulations, Span 60 and cholesterol are used in a ratio of at least 2:1. As a result, the particle sizes of the formulations range from 237.1 nm to 351.1 nm. The particle size distribution (PDI) of all the formulations is less than or equal to 1 indicating a narrow size distribution.
[0048] According to another embodiment of the invention, FIGs. 3A-36B refer to graphical representations (300, 302) for the particle size distribution of N1 and N2 for the gastroprotective niosomal syrup 100. In one embodiment herein, the X-axis represents the size (d.nm), which indicates the size of the particles in nanometers (nm), which typically refers to the diameter of the molecules or particles. It shows the range of sizes present in each formulation. In one embodiment herein, the Y-axis represents the intensity (percent) of the signal detected during particle size measurement, often indicating the percentage of particles at each size range.
[0049] Both formulations, N1 and N2, exhibit a range of particle sizes. Formulation N2 generally shows slightly larger particle sizes compared to N1, as observed from the graphical representations (300, 302). In one embodiment herein, the graphical representations (300, 302) provide visual insights into the distribution of particle sizes in the niosomal formulations N1 and N2. They demonstrate that while both formulations cover a range of sizes, formulation N2 tends to have particles that are slightly larger on average than those in formulation.
[0050] According to another embodiment of the invention, FIGs. 3C-3D refer to graphical representations (304, 306) for zeta potential distribution of N1 and N2 for the gastroprotective niosomal syrup 100. In one embodiment herein, X-axis represents apparent zeta potential of the particles in millivolts (mV) and y-axis represents counts. The graphical representations (304, 306) depicts that the particles in both formulations have a positive zeta potential. In addition, the zeta potential of the particles in formulation N2 is slightly higher than the zeta potential of the particles in formulation NI. The positive zeta potential suggests that the particles in both formulations are likely to repel each other, which contributes to their stability in dispersion.
[0051] Table 3:
Time (min) Cumulative Percentage Drug release (CPD)
NS1 NS2
0 0 0
15 27.57 ± 0.23 44.00 ± 0.70
30 33.04 ± 0.31 48.70 ± 0.77
45 48.78 ± 0.47 51.48 ± 0.26
60 61.74 ± 0.80 75.74 ± 0.67
90 68.78 ± 0.98 83.56 ± 0.29
120 73.21 ± 0.81 90.62 ± 0.73
180 78.70 ± 0.58 93.48 ± 0.56
240 89.56 ± 0.78 97.83 ± 0.83

[0052] In one embodiment herein, table 3 represents cumulative percentage drug release (CPD) data over time (in minutes) for formulations NS1 and NS2. In particular, the formulation NS2 consistently shows higher cumulative drug release compared to NS1 across all time points. This higher drug release from NS2 is likely due to its relatively higher entrapment efficiency, as indicated by the greater amount of drug released over time compared to NS1. Entrapment efficiency refers to the percentage of drug encapsulated within the niosomal structure, influencing the amount of drug available for release. The data suggest that NS2's formulation allows for more efficient release of nizatidine, potentially enhancing its therapeutic efficacy compared to NS1 in drug delivery applications.
[0053] According to another embodiment of the invention, FIG. 4A refers to a scanning electron microscope (SEM) 400 of N1 for the gastroprotective niosomal syrup100. According to another embodiment of the invention, FIG. 4B refers to a scanning electron microscope (SEM) 402 of N2 for gastroprotective niosomal syrup 100. In one embodiment herein, the surface morphology of the niosomes (liposomes loaded with nizatidine) was examined using SEM. An accelerating voltage of 30 kV was used for imaging.
[0054] In one embodiment herein, the scanning electron microscope (SEM) images of N1 and N2 (400, 402) reveal that the niosomes appear spherical in shape. The surfaces of the niosomes are observed to be smooth, indicating a uniform and stable structure. No pores or irregularities are visible on the surface of the niosomes in either formulation (N1 or N2). These SEM observations provide visual confirmation of the structural integrity and surface characteristics of the niosomal formulations N1 and N2. As a result, these formulations are suitable for controlled drug delivery applications, thereby ensuring stability and efficient release of nizatidine.
[0055] According to another example embodiment of the invention, FIGs. 5A-5D refer to pictorial representations (500, 502, 504, 506) of four groups of rats, each of which likely receiving a different treatment. In one example embodiment herein, before treatment, all animals underwent a 24-hour fasting period. Nizatidine-optimized formulations were then administered to three test groups as preventive measures. In this experimental setup, ulcers were induced intraperitoneally by orally administering histamine (300 mg/kg) one hour after administering Nizatidine (100 mg/kg, orally) and the optimized formulations.
[0056] Animals were euthanized six hours after ulcer induction. The stomachs were isolated, opened along the greater curvature to expose the inner surface, and the glandular portion was used to assess ulcer formation. The number and length of each ulcer were recorded. In addition, the measurements such as gastric volume, pH levels, total acidity, area of ulcer, and ulcer index across the groups, highlighting the efficacy and comparative outcomes of the treatments.
[0057] Table 4:
Groups Gastric volume (ml) pH Total acidity (mEq/L) Area of ulcer (mm2) Ulcer index (UI)
Vehicle 3.61 ± 0.23 3.42 ± 0.16 22.90 ± 3.07 -- --
Ulcer control 5.23 ± 0.12 2.48 ± 0.23 50.23 ± 2.34 9.34 ± 1.12 1.48 ± 0.23
Nizatidine (100 mg/kg) 3.45 ± 0.18 5.21 ± 0.22 33.09 ± 1.56 3.42 ± 0.89 0.45 ± 0.12
NS1 2.98 ± 0.12 4.98 ± 0.10 31.98 ± 1.11 3.33 ± 0.93 0.56 ± 0.34
NS2 2.78 ± 0.20 5.78 ± 0.14 26.87 ± 1.08 2.78 ± 1.09 0.34 ± 0.09

[0058] In one embodiment herein, the vehicle group serves as the normal control, untreated and without induced ulcers as depicted in FIG. 5A. The ulcer control, likely exhibiting severe ulcers without receiving nizatidine or the optimized formulations as depicted in FIG. 5B. The nizatidine, a standard medication for ulcer treatment as depicted in FIG. 5C. NS2 presumably received one of the optimized formulations as depicted in FIG. 5D. Based on the image analysis, rats in the ulcer control group displayed the most severe ulcers. Conversely, groups receiving the NS2 and nizatidine exhibit less severe ulcers.
[0059] According to another embodiment of the invention, FIG.s 6A-6D refer to pictorial representations (600, 602, 604, 606) of stomach histopathology of rats, which are treated with Nizatidine and optimized formulation. In one example embodiment herein, histamine plays a crucial role in the development of gastric ulcers due to its potent stimulation of H2 receptors found on parietal cells in the stomach. When histamine binds to these receptors, it triggers a cascade of events. Firstly, it stimulates parietal cells to secrete gastric acid, which is a primary factor in ulcer formation. Additionally, histamine's ability to cause vasodilation increases vascular permeability, further contributing to ulcer development.
[0060] The induction of gastric ulcers through histamine administration is well-established and primarily occurs via the stimulation of H2 receptors. This stimulation leads to increased gastric acid secretion and vasodilation, both of which are key mechanisms in ulcer pathogenesis. The activities of Nizatidine, NS1, and NS2 in protecting against histamine-induced ulcers are detailed in table 4. Nizatidine, as an H2 receptor antagonist, inhibits ulcer formation by blocking histamine's action on these receptors, thereby reducing gastric acid secretion and maintaining a higher gastric pH.
[0061] NS1 and NS2, which are likely similar compounds that also block H2 receptors, demonstrate therapeutic efficacy by similarly inhibiting ulcer formation, increasing gastric pH, and reducing gastric volume compared to untreated groups. Histopathological examination of stomach samples from normal control rats reveals a healthy appearance, with intact layers of the fundus and darker glandular mucosa due to the presence of epithelial and connective tissue nuclei. Thin pink stripes in the muscular mucosa indicate normalcy as depicted in FIG. 6A.
[0062] In contrast, rats exposed to histamine show severe disruptions in the glandular epithelium, characterized by shedding of cells. Edema in the submucosal layer, cellular infiltration, and congested blood vessels are also evident as depicted in FIG. 6B. However, pre-treatment with Nizatidine mitigates some of this damage, limiting disruption to the superficial epithelium with fewer detached cells as depicted in FIG. 6C. Pre-treatment with NS2, on the other hand, results in notable disruptions to the glandular epithelium, shedding of cells, edema in the submucosal layer, thickened muscularis mucosa, congested blood vessels, and cellular infiltration as depicted in FIG. 6D.
[0063] Overall, these findings illustrate how histamine, through its actions on H2 receptors, induces gastric ulcers by increasing gastric acid secretion and vasodilation. The protective effects of Nizatidine and the optimized formulations (NS1 and NS2) against histamine-induced ulcers are demonstrated through their ability to inhibit these processes, thereby reducing ulcer severity in experimental models.
[0064] According to another example embodiment of the invention, development of Nizatidine gastroprotective niosomal syrup with natural bioenhancer is disclosed. One of the primary goals is to create the gastroprotective niosomal syrup 100 of Nizatidine that includes a natural bioenhancer. Niosomes are nano-sized vesicles composed of non-ionic surfactants and cholesterol, used to encapsulate drugs for targeted delivery and enhanced bioavailability. Incorporating a natural bioenhancer, such as cow urine-fortified plant extracts, aims to improve the therapeutic efficacy and gastrointestinal tolerance of Nizatidine.
[0065] In one embodiment herein, another key objective is to formulate the gastroprotective niosomal syrup 100 fortified with cow urine and specific plant extracts known for their gastroprotective properties. Cow urine has been traditionally recognized for its medicinal benefits and is explored here for its potential to enhance the therapeutic effects of the niosomal syrup. This combination aims to provide a holistic approach to gastrointestinal health, leveraging natural ingredients alongside pharmaceutical innovation.
[0066] Table 6:
Ingredients NS1 NS2
Nizatidine Niosomes (5 ml) 5 ml 5 ml
Sucrose (gm) 66.7 66.7
Purified water (ml) 10 ml 10 ml

[0067] In one embodiment herein, table 6 details the final Niosomal syrup formulations (NS1 and NS2) used in testing and application. For example, the Nizatidine niosomes of 5 ml, sucrose of 66.7 gm, and purified water of 10 ml are mixed to form the gastroprotective niosomal syrup 100.
[0068] In one embodiment herein, the effectiveness of the Niosomal syrup formulations was evaluated by their ability to reduce ulcer scores induced by histamine. This testing confirmed their potential to protect the gastrointestinal lining from damage, demonstrating their therapeutic relevance. Furthermore, the Niosomal syrup formulations exhibited notable acid-neutralizing capacity, which is crucial for managing conditions like gastric ulcers. They also demonstrated antiulcerogenic and antisecretory activities, highlighting their comprehensive therapeutic potential beyond mere symptom relief.
[0069] Numerous advantages of the present disclosure may be apparent from the discussion above. In accordance with the present disclosure, a method for preparing a gastroprotective niosomal syrup using tradescantia pallida extract is known. The proposed gastroprotective niosomal syrup 100 utilizes tradescantia pallida extract to enhance drug efficacy. The proposed gastroprotective niosomal syrup 100 providing significant acid-neutralizing capacity and antiulcerogenic and antisecretory activity.
[0070] The proposed gastroprotective niosomal syrup 100 enhances gastroprotective activity by encountering the ulcer score caused by histamine-induced ulcers. The proposed gastroprotective niosomal syrup 100 demonstrating a reduction in ulcer formation, confirming the efficacy of the treatment. The proposed gastroprotective niosomal syrup 100 enhances the drug’s permeation efficacy. The proposed gastroprotective niosomal syrup 100 enhances drug efficiency.
[0071] It will readily be apparent that numerous modifications and alterations can be made to the processes described in the foregoing examples without departing from the principles underlying the invention, and all such modifications and alterations are intended to be embraced by this application.
, Claims:CLAIMS:
I / We Claim:
1. A composition for preparing a gastroprotective niosomal syrup (100), comprising:
4 to 8 weight percentage of Nizatidine niosomes (10);
79 to 83 weight percentage of sucrose (12); and
10 to 14 weight percentage of purified water (14).
2. The composition for preparing a gastroprotective niosomal syrup (100) as claimed in claim 1, wherein the Nizatidine niosomes (10) comprises:
1.7 to 1.9 weight percentage of Nizatidine (102);
2.6 to 2.8 weight percentage of a fortified product (104);
1.7 to 1.9 weight percentage of a cholesterol (106);
3.5 to 3.7 weight percentage of a Span 60 (108); and
89 to 91 weight percentage of a phosphate buffer solution (110).
3. The composition for preparing a gastroprotective niosomal syrup (100) as claimed in claim 2, wherein the fortified product (104) is prepared by dissolving small segments of sliced Trandescantia pallida leaves in cow urine, thereby enhancing the growth of the trandescantia pallida.
4. The composition for preparing a gastroprotective niosomal syrup (100) as claimed in claim 2, wherein the span 60 (108) and the cholesterol (106) are formulated at a ratio of at least 2:1.
5. The composition for preparing a gastroprotective niosomal syrup (100) as claimed in claim 1, wherein the gastroprotective niosomal syrup (100) is encapsulated in at least one of a syrup, a tablet and a capsule.
6. The composition for preparing a gastroprotective niosomal syrup (100) as claimed in claim 1, wherein a particle size of the gastroprotective niosomal syrup (100) varies between 237.1 nm and 351.1 nm.
7. The composition for preparing a gastroprotective niosomal syrup (100) as claimed in claim 1, wherein the gastroprotective niosomal syrup (100) demonstrates significant acid-neutralizing capacity, along with notable antiulcerogenic and antisecretory activity.
8. A method for preparing a gastroprotective niosomal syrup (100), comprising:
collecting Trandescantia pallida leaves and slicing them into small segments;
dissolving the small segments in cow urine for preparing a fortified product (104), thereby enhancing the growth of the trandescantia pallida;
dissolving Nizatidine (102) in a phosphate buffer solution (110) to obtain a Nizatidine mixture;
mixing the Nizatidine mixture with the fortified product (104) to form a first solution;
injecting a second solution into the first solution to obtain a Nizatidine niosomes (10); and
mixing 66.7 gm of sucrose (12) with 10 ml of purified water (14) for preparing a third solution, thereby blending 5 ml of Nizatidine niosomes (10) into the third solution to obtain the gastroprotective niosomal syrup (100).
9. The method as claimed in claim 7, wherein the second solution is prepared using cholesterol (106), Span 60 (108) and an ethanol.
10. The method as claimed in claim 7, wherein the gastroprotective niosomal syrup (100) demonstrates a reduction in ulcer formation, confirming the efficacy of the treatment.