DESC:DESCRIPTION:
Field of the invention:
[0001] The present disclosure generally relates to the technical field of a biotechnology, in specific, relates to a composition for controlled intestinal release of therapeutic proteins, particularly recombinant human insulin, to aid in the regulation of blood glucose levels in diabetic patients.
Background of the invention:
[0002] Diabetes mellitus is a chronic metabolic disorder characterized by elevated blood glucose levels resulting from the body’s inability to produce sufficient insulin or effectively utilize the insulin produced. Conventional diabetes management typically involves the regular administration of insulin via subcutaneous injections. Although effective in regulating blood glucose, these injections are associated with several drawbacks, including patient discomfort, risk of infection, and potential adverse effects such as hypoglycemia (sudden drop in blood glucose levels) and, in severe cases, coma.

[0003] Existing large-scale insulin production predominantly employs recombinant DNA technology using bacterial or yeast expression systems. These processes require extensive fermentation, rigorous purification steps, stringent sterile conditions, and substantial infrastructure investment, all of which increase production costs. Advances in plant biotechnology have enabled the expression of pharmaceutical proteins in transgenic plants. Such systems offer multiple advantages over microbial expression, including reduced cultivation costs, minimal maintenance requirements, and the elimination of sterile growth conditions.

[0004] Moreover, plant-based systems significantly reduce the risk of contamination with human pathogens, making them inherently safer for therapeutic protein production. Diabetes is primarily classified into two categories: type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) and type 2 diabetes (non-insulin-dependent diabetes mellitus, NIDDM). The World Health Organization (WHO) projects that, due to factors such as aging populations, rising obesity rates, poor dietary habits, and sedentary lifestyles, the global prevalence of diabetes will increase from 135 million in 1995 to 300 million by 2025.

[0005] Type 1 diabetes is often linked to genetic predisposition associated with the HLA-D gene on the short arm of chromosome 6. Environmental triggers such as viral infections or exposure to toxic chemicals may induce autoimmune destruction of pancreatic ß-cells, leading to inadequate insulin production. This form typically presents with a rapid onset of symptoms, including excessive hunger, excessive urination, excessive thirst, and unexplained weight loss. Patients are prone to ketosis and require lifelong insulin therapy.

[0006] Type 2 diabetes is influenced by both genetic and environmental factors and involves a combination of insulin resistance and relative insulin deficiency. Insulin resistance plays a critical role in disease progression, particularly among obese individuals. Research targeting insulin signaling pathways in adipose and muscle tissues aims to develop euglycemic agents to improve insulin sensitivity, making this a major focus of current drug development. Oral administration of insulin is not currently viable due to degradation by gastric acid, bile salts, digestive enzymes, and other gastrointestinal factors, rendering the protein inactive before absorption.

[0007] Various attempts to develop orally administered insulin formulations have been unsuccessful. Consequently, insulin delivery remains reliant on subcutaneous injections via syringes, insulin pens, or infusion pumps, using combinations of long-acting and short-acting insulin to mimic natural pancreatic secretion patterns. Some patients use injection ports in conjunction with syringes or pumps to reduce the frequency of skin punctures. However, these approaches present drawbacks such as high cost, risk of glycemic fluctuations, catheter-related complications, infection, ulceration, and lipodystrophy at infusion sites. Pump systems also require consistent monitoring and management.

[0008] Certain prior-art oral insulin delivery systems employ dissolvable films comprising polymeric layers with agents such as polyoxyethylene lauryl ether, polyethylene glycol–polyvinyl alcohol copolymers, and cross-linked acrylic acid polymers. However, such systems have demonstrated irreversible degradation characteristics and present higher risks compared to other administration routes.

[0009] Therefore, there is a need for an edible plant product that is capable of delivering insulin in a safe, non-invasive, and effective manner to regulate blood glucose levels in diabetic patients, while eliminating the need for frequent skin punctures. Further, there is also a need for an edible plant product that is suitable for all age groups, including children and the elderly, and should reduce or eliminate the discomfort, risks, and limitations associated with conventional insulin injection methods.
Objectives of the invention:
[0010] The primary objective of the present invention is to provide a composition for controlled intestinal release of therapeutic proteins, particularly recombinant human insulin, to aid in the regulation of blood glucose levels in diabetic patients.

[0011] Another objective of the present invention is to provide a composition that is consumed orally, eliminating the need for injections and associated discomfort.

[0012] The other objective of the present invention is to provide a composition that is a slow release of insulin in the intestines to prevent sudden drops in blood glucose levels, reducing the risk of hypoglycaemia and associated symptoms such as dizziness, weakness, and fainting.

[0013] The other objective of the present invention is to provide a composition that utilizes a cell wall of the plant cell to protect the insulin from degradation in the acidic environment of the stomach, ensuring that the insulin reaches the intestines intact.

[0014] The other objective of the present invention is to provide a composition that is consumed directly with food, thereby making it convenient for patients to incorporate into their daily routine.

[0015] The other objective of the present invention is to provide a composition that applies to a variety of raw edible plant parts, including leaves, flowers, and fruits, providing flexibility in production and consumption.

[0016] The other objective of the present invention is to provide a composition that is safe for all age groups, including children and elderly persons, offering a versatile solution for diabetes management.

[0017] Yet another objective of the present invention is to provide a composition that is modified plants, which can be grown organically under controlled laboratory conditions, ensuring a safe and sustainable production process.

[0018] Further objective of the present invention is to provide a composition with convenience and non-invasiveness of edible insulin that promotes better patient compliance with diabetes management regimens.
Summary of the invention:
[0019] The present disclosure proposes a composition for controlled release of human insulin. 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.

[0020] In order to overcome the above deficiencies of the prior art, the present disclosure is to solve the technical problem to provide a composition for controlled intestinal release of therapeutic proteins, particularly recombinant human insulin, to aid in the regulation of blood glucose levels in diabetic patients.

[0021] According to an aspect, the invention provides a composition for controlled release of human insulin. In one embodiment herein, the composition comprises plant-derived cells isolated and obtained from a genetically modified edible plant, the plant-derived cells having intact cell walls, and a recombinant human insulin polypeptide expressed within the plant-derived cells.

[0022] In one embodiment herein, the plant-derived cells are processed post-harvest, and the intact cell walls are configured to protect the recombinant human insulin polypeptide from gastric degradation and to permit release in the intestinal environment upon microbial digestion, thereby enabling gradual absorption of the insulin into the bloodstream. The cell walls of the plant-derived cells provide a delayed and controlled release of the recombinant human insulin polypeptide in the intestinal tract.

[0023] In one embodiment herein, the genetically modified edible plant is selected from the group consisting of cabbage, lettuce, spinach, carrot, tomato, and combinations thereof. The plant-derived cells are processed post-harvest into a form selected from the group consisting of dried powder, encapsulated powder, compressed tablets, and raw edible harvested plant parts.

[0024] The genetically modified edible plants are cultivated under controlled greenhouse or laboratory conditions to prevent cross-pollination with non-modified plants and to ensure consistent recombinant human insulin expression. The plant-derived cells are substantially free of additional active pharmaceutical ingredients or inactive excipients, and the composition is formulated as an oral dosage form configured for consumption in conjunction with food, without the inclusion of other active or inactive ingredients.

[0025] 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:
[0026] 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.

[0027] FIG. 1 illustrates a schematic view of the preparation of human edible insulin using an edible plant product, in accordance to an exemplary embodiment of the invention.
Detailed invention disclosure:
[0028] 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.

[0029] 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 composition for controlled intestinal release of therapeutic proteins, particularly recombinant human insulin, to aid in the regulation of blood glucose levels in diabetic patients.

[0030] According to an exemplary embodiment of the invention, a composition for controlled release of human insulin. In one embodiment herein, the composition comprises plant-derived cells isolated and obtained from a genetically modified edible plant, the plant-derived cells having intact cell walls, and a recombinant human insulin polypeptide expressed within the plant-derived cells.

[0031] In one embodiment herein, the plant-derived cells are processed post-harvest, and the intact cell walls are configured to protect the recombinant human insulin polypeptide from gastric degradation and to permit release in the intestinal environment upon microbial digestion, thereby enabling gradual absorption of the insulin into the bloodstream. The cell walls of the plant-derived cells provide a delayed and controlled release of the recombinant human insulin polypeptide in the intestinal tract.

[0032] In one embodiment herein, the genetically modified edible plant is selected from the group consisting of cabbage, lettuce, spinach, carrot, tomato, and combinations thereof. The plant-derived cells are processed post-harvest into a form selected from the group consisting of dried powder, encapsulated powder, compressed tablets, and raw edible harvested plant parts. The genetically modified edible plants are cultivated under controlled greenhouse or laboratory conditions to prevent cross-pollination with non-modified plants and to ensure consistent recombinant human insulin expression. The plant-derived cells are substantially free of additional active pharmaceutical ingredients or inactive excipients, and the composition is formulated as an oral dosage form configured for consumption in conjunction with food, without the inclusion of other active or inactive ingredients.

[0033] The composition comprises plant-derived cells obtained from genetically modified edible plants, including vegetables, leaves, flowers, and roots. The plant-derived cells express recombinant human insulin within their cytoplasm and are enclosed by intact plant cell walls, which act as natural bioencapsulation barriers. This configuration protects the insulin until it reaches the intestinal tract, thereby enabling its effective delivery. In one embodiment, the composition is administered orally, eliminating the need for injections and the associated discomfort. The controlled release of insulin in the intestines reduces the risk of sudden hypoglycaemia and associated symptoms such as dizziness, weakness, and fainting.

[0034] In one embodiment herein, the genetically modified edible plant is selected from the group consisting of vegetables, fruits, and grains. The plant-derived cells are processed post-harvest, ensuring that the recombinant human insulin remains enclosed within the cell walls until administration.

[0035] In one embodiment herein, the composition suitable for supporting blood glucose management through the use of plant-derived cells containing recombinant human insulin. This approach leverages genetic engineering to enable daily oral intake of the insulin-containing material, thereby reducing dependency on conventional insulin injections and avoiding related drawbacks such as pain, risk of infection, hypoglycaemia, and refrigeration requirements.

[0036] In one example embodiment, the genetically modified plants are engineered to express recombinant human insulin by inserting a complementary deoxyribonucleic acid (cDNA) segment encoding the insulin into a plant-compatible expression system, such as a plant virus vector, followed by transduction of plant cells. The method is applicable to edible plant varieties, including but not limited to cabbage, lettuce, spinach, carrot, and tomato. The recombinant insulin, once ingested, is gradually absorbed into the bloodstream following microbial degradation of the cell walls in the intestinal environment.

[0037] According to another embodiment of the invention, FIG. 1 refers to a schematic view 100 of the preparation of a composition for controlled release of human insulin. At step 102, the genetically modified edible plant is cultivated under controlled laboratory or greenhouse conditions. These plants are engineered to express the human insulin gene within their cells and are grown organically to ensure safety, quality, and consistency of insulin production. The plant cell walls, composed of cellulose, naturally encapsulate and protect the insulin from degradation in the stomach.

[0038] At step 104, once the plants have matured, the edible portions such as leaves, roots, and flowers are harvested. These plant parts contain the bioencapsulated human insulin and can be used directly or prepared for further processing. The harvested material is cleaned and ground to create a plant extract, or alternatively, it can be freeze-dried to preserve bioactivity before grinding into a fine powder.

[0039] At step 106, involves processing the powdered material into various final dosage forms. The powder may be packaged directly into sealed pouches for consumption as-is, or it may be encapsulated into hard gelatin capsules or compressed into tablets for convenient oral administration. In all formats, the insulin remains enclosed within the plant cell walls until ingestion.

[0040] When consumed, the plant cells pass through the stomach intact due to the indigestibility of cellulose by human enzymes. In the intestine, gut bacteria degrade the plant cell walls, gradually releasing the insulin for absorption into the bloodstream. This slow, controlled release helps maintain stable blood glucose levels and reduces the risk of hypoglycemia associated with conventional insulin injections. The process leverages renewable plant resources, offers a needle-free insulin delivery method, and is suitable for both type 1 and type 2 diabetes patients.

[0041] The approach leverages renewable plant resources and avoids the infection risks and extensive sterilization requirements associated with microbial or animal-based insulin production systems. Additionally, cultivation and processing are cost-efficient, and the composition can achieve high insulin yields, subject to expression optimization. In one embodiment, the composition eliminates the need for injectable delivery systems, improves patient compliance, and provides a portable, user-friendly format. The gradual insulin release reduces blood sugar fluctuations and reliance on synthetic delivery materials, making the approach suitable for large-scale, low-cost production.

[0042] In another embodiment, the genetically modified plants are produced using Agrobacterium tumefaciens-mediated transformation. The cDNA sequence encoding human insulin is inserted into a suitable plasmid vector, introduced into A. tumefaciens, and used to transform plant callus tissue, enabling stable genomic integration. Following transformation, the plants are grown under controlled environmental conditions, including regulated light, humidity, and temperature, to ensure consistent recombinant insulin expression. Once mature, the edible plant portions are harvested for processing.

[0043] The harvested material is consumed in a processed form, such as dried powder, capsules, or tablets, or may be eaten directly in its raw form. The quantity for consumption may be determined according to individual requirements, based on professional medical guidance, ensuring safe and effective insulin delivery.

[0044] Numerous advantages of the present disclosure may be apparent from the discussion above. In accordance with the present disclosure plant-based composition 100 is method, is disclosed. The proposed composition is consumed orally, eliminating the need for injections and associated discomfort. The proposed composition is slow release of insulin in the intestines to prevent sudden drops in blood glucose levels, reducing the risk of hypoglycaemia and associated symptoms such as dizziness, weakness, and fainting.

[0045] The proposed composition utilizes the cell wall of the plant cell to protect the insulin from degradation in the acidic environment of the stomach, ensuring that the insulin reaches the intestines intact. The proposed composition consumes directly with food, thereby making it convenient for patients to incorporate into their daily routine. The proposed composition applies to a variety of raw edible plant parts, including leaves, flowers, and fruits, providing flexibility in production and consumption. The proposed composition is safe for all age groups, including children and elderly persons, offering a versatile solution for diabetes management.

[0046] The proposed composition can be grown organically under controlled laboratory conditions, ensuring a safe and sustainable production process. The proposed a plant-based composition that convenience and non-invasiveness of edible insulin promote better patient compliance with diabetes management regimens.

[0047] 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 controlled release of human insulin, comprising:
a plant-derived cells obtained a genetically modified edible plant, wherein the plant-derived cells having intact cell walls; and
a recombinant human insulin polypeptide expressed within the plant-derived cells,
wherein the plant-derived cells are processed post-harvest and the cell walls are configured to protect the human insulin polypeptide from gastric degradation and allow release in the intestinal environment upon microbial digestion, thereby resulting in gradual absorption of the insulin into the patient’s bloodstream.
2. The composition as claimed in claim 1, wherein the plant-derived cells are obtained from the genetically modified edible plant, which is selected from the group comprises of cabbage, lettuce, spinach, carrot, tomato, and combinations thereof.
3. The composition as claimed in claim 1, wherein the plant-derived cells are processed post-harvest into a form selected from the group comprises of dried powder, encapsulated powder, compressed tablets, and raw edible harvested plant parts.
4. The composition as claimed in claim 1, wherein the genetically modified edible plants are cultivated under controlled greenhouse or laboratory conditions to prevent cross-pollination with non-modified plants and to ensure consistent recombinant human insulin expression.
5. The composition as claimed in claim 1, wherein the plant-derived cells are substantially free of additional active pharmaceutical ingredients or inactive excipients.
6. The composition as claimed in claim 1, wherein the composition is formulated as an oral dosage form configured for consumption in conjunction with food.
7. The composition as claimed in claim 1, wherein the composition is adapted to provide delayed release of the recombinant human insulin polypeptide in the intestinal tract.
8. The composition as claimed in claim 1, wherein the composition is formulated for consumption without the inclusion of other active or inactive ingredients.