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A Periodontal Chip Formulation Of Pongamia Pinnata

Abstract: ABSTRACT A PERIODONTAL CHIP FORMULATION OF PONGAMIA PINNATA The present invention is a periodontal chip formulation of Pongamia pinnata. In particular the present invention is a periodontal chip formulation of Pongamia pinnata comprising Pongamia pinnata, atleast one sustained released polymer, a plasticizer, and one or more inactive agents. The present invention is also a process of preparing periodontal chip formulation of Pongamia pinnata.

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Patent Information

Application #
Filing Date
20 August 2021
Publication Number
08/2023
Publication Type
INA
Invention Field
BIO-CHEMISTRY
Status
Email
patent@excelonip.com
Parent Application

Applicants

RK University
School of Pharmacy, RK University, Rajkot – 360020, Gujarat, INDIA.

Inventors

1. Vivek Joshi
RK University, Rajkot-360020, Gujarat, India
2. Dr. Devang Pandya
RK University, Rajkot, Gujarat, INDIA 360020
3. Vishvesh Kanabar
RK University, Rajkot-360020, Gujarat, India

Specification

DESC:
FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)
1. Title of the invention – A PERIODONTAL CHIP FORMULATION OF PONGAMIA PINNATA
2. Applicant(s)
NAME: R K University
NATIONALITY: INDIAN
ADDRESS: School of Pharmacy, RK University, Rajkot – 360020, Gujarat, INDIA.
3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed.

A PERIODONTAL CHIP FORMULATION OF PONGAMIA PINNATA
FIELD OF THE INVENTION
The present invention is related to periodontal chip formulation of Pongamia pinnata. In particular the present invention is related to a periodontal chip formulation of Pongamia pinnata comprising Pongamia pinnata salivary ext., two sustained released polymer, a plasticizer and vehicle. The present invention is also related to process of preparing periodontal chip formulation of Pongamia pinnata salivary ext.

BACKGROUND OF THE INVENTION
Dental illness is one of the most serious problems after Diabetes and cardiovascular diseases across the world. Dental caries, periodontitis, gingivitis, plaque, oral cancer, etc. are the most prevailing ones. Treatment and surgeries can cost plenty, with no guarantee of permanent cure. However, Ayurveda, one of the Indian traditional systems of medicine has invaluable chest of medicinal plants, which are prescribed in Ashtang Hridaya, Ayurvedic ancient literature penned by Vagbhata. Daily use of fresh herbal twigs for cleaning of teeth can aid in prevention and management of gum bleeding, plaque and oral infection and promotion of oral health.

Dental hygiene is one of the crucial aspects of life that most of the humans ignore that could majorly lead to dental caries, gingivitis, dental plaque, cavities, bleeding gums, periodontitis, oral cancer, etc. According to a recent study, at least 8 out of 10 children in India suffer from oral health issues; while 2 out of 3 children have cavities or are at high risk of developing them. It also revealed that 9 out of 10 surveyed adults suffered from a major oral health problem. It highlighted that more than 70% of surveyed children did not brush their teeth twice a day, being the major cause for depletion of oral health in adults as well.

People have been using medicinal plants like Neem, Babul, Lavang, Karanj, Miswak and others due to their wide ethnomedicinal usefulness since ancient times. To prevent and manage dental issues, varieties of herbal dental products containing extracts of medicinal plants such as toothpaste, mouth wash, essential oil, dentifrices, etc. are available in the market. Various herbal formulations are available in market containing extracts of medicinal plants like DANTKANTI®, SUDANTA®, DABUR PULLING OIL®, HIMALAYA ACTIVE FRESH GEL®, DANT MANJAN LAL®, SWARNA VEDSHAKTI®, etc. However, intended sustained effect for more than few hours could not be achieved and their prolonged use could lead to discoloration and dental defects due to chemical preservatives and abrasive excipients. In case of surgeries and implants, proper cleaning of teeth becomes difficult, where the patient could become more susceptible to formation of plaques by microbial contamination.

Pongamia pinnata Pierre (P. pinnata); synonyms Pongamia glabra, Milletia pinnata, Derris indica, has been a potentious medicinal plant in Ayurveda for its traditional uses. Fresh twigs (stems) of P. pinnata also possess ethnomedicinal importance for prevention of dental disorders.

Periodontal chip is a biodegradable and bio-mucoadhesive patch-like novel approach of buccal drug delivery system, which is used to treat periodontal issues. It is generally applied to the periodontal pocket. It contains active drug molecules which act upon locally on the applied area. However, general conventional method for formulation using synthetic drugs have demerits like frequent administration of dosage form, partially potent drug or lacking patient compliance along with adverse side effects. It should be stacked to the infected tooth/teeth or fixed in gums, if necessary. It serves the purpose of sustained drug release as well as reduces frequency of dose administration.

Biodegradable PerioChip containing Thymoquinone for managing chronic periodontitis was formulated and evaluated by Fouad et. al. in 2013, which showed promising results as compared to conventional treatments and surgeries.

Indian patent application number IN 991/DEL/2010 discloses an herbal preparation comprising a blend of extracts of the said plants/trees and their active ingredients which are effective for improving the oral care practices. The process for preparing the formulation comprises following steps: - Combined the dried latex (1 kg) of Ratanjyot (Jatropha curcas) with dried leaves (500 gm) of Neem (Azadirachta indica) & white ash resulting out of brick baking process of Acacia nelotica, Achyranthus aspera, Commiphora myrrha and Pongamia pinnata . Further, these all ingredients are crushed to powder form and mixed together. The composition may be prepared as various dosage forms such as powdered, gel, paste form for oral administration.

Indian patent application number IN201741032950 discloses a formulation of multi herbal tooth care product for teeth and gums. Since the components in the formulation are from herbal source it is very safe and eco-friendly and do not produce any adverse effect on the gums and teeth. It comprises of extracts of Karanj (Ponagamia pinnata), apamarga (Achyranthus aspera), ginger (Zingiber officinalis), banyan (Ficus bengalensis), tulsi (Occimum sanctum), turmeric (Curcuma longa), clove (Syzygium aromaticum) and betal (Piper longum).

The cited documents possess certain demerits as they are powdered, gel and paste formulation and due to that the patient compliance cannot be achieved at certain level as they cannot provide sustained release of drug and stability issues.

The main purpose of the present invention is to provide a stable, effective formulation that provides pharmacologically effective resemblance as that of the raw drug as the present invention uses salivary extract of the Pongamia pinnata and with minimal use of other excipients and it is stable and provides patient compliance. The below lies the object of the present invention

OBJECTIVE OF THE INVENTION
The main objective of this invention is to provide periodontal chip formulation of Pongamia pinnata.

Another objective of this invention is to provide periodontal chip formulation of Pongamia pinnata for dental usage.

Another objective of the present invention is to provide a periodontal chip formulation of Pongamia pinnata that reduces dosage frequency.

Yet another objective of the present invention to provide a periodontal chip formulation of Pongamia pinnata which is stable.

Yet another objective of the present invention is to provide a periodontal chip formulation of Pongamia pinnata that prevents teeth discoloration.

Yet another objective of the present invention is to provide a periodontal chip formulation of Pongamia pinnata that does not contain any abrasive ingredient or preservatives.

Yet another objective of the present invention is to provide a periodontal chip formulation of Pongamia pinnata that is highly patient compatible.

SUMMARY OF THE INVENTION
The main aspect of the present invention is to provide the periodontal chip formulation of Pongamia pinnata.

Another aspect of the invention is to provide periodontal chip formulation of Pongamia pinnata comprising salivary extract of Pongamia pinnata, two sustained released polymer, a plasticizer and vehicle.

Yet another aspect of the invention is the process of preparing a periodontal chip formulation of Pongamia pinnata salivary extract.

DESCRIPTION OF THE INVENTION
The main embodiment of the present invention is to provide periodontal chip formulation of Pongamia pinnata.

As per the embodiment the formulation of Pongamia pinnata comprises salivary extract of Pongamia pinnata, two sustained released polymer, a plasticizer and vehicle.

The present invention overcomes the aforesaid drawbacks of the above, and other objects, features and advantages of the present invention will now be described in greater detail. Also, the following description includes various specific details and are to be regarded as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that: without departing from the scope and spirit of the present disclosure and its various embodiments there may be any number of changes and modifications described herein.

The wording herein below is implied in the common meaning of the definitions and statements as known to the versed in the art of pharmaceuticals and polymer science.

As per one embodiment, the formulation of the present invention represents an ideal dosage form to get freedom from complex dosage regimen and patient non-compliance. The formulation of present invention as described herein provide ready to use periodontal chips of P.pinnata.

As used in this document, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

Nothing in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term "comprising" means "including, but not limited to."

"Optional" or "optionally' means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where the event occurs and instances where it does not.

As used herein the term “ready to use” means the chip is to be used directly for oral administration without any reconstitution.

As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible sub ranges and combinations of sub ranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, et cetera As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, et cetera As will also be understood by one skilled in the art all language such as “up to,” “at least,” and the like include the number recited and refer to ranges which can be subsequently broken down into sub ranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member.

As used herein term “formulation” or “composition” or “dosage” conveys the same meaning and can be used interchangeably.

As used herein, the term "about" means plus or minus 10% of the numerical value of the number with which it is being used.

As used herein, 'therapeutically effective amount" or "effective amount" of a composition is a predetermined amount calculated to achieve the desired effect, i.e., to induce a favourable therapeutic response.

As used herein, the “periodontal chip formulation,” includes ready-to-use dental chips. The ready-to-use dental chips comprises a solution, a suspension, a concentrate or an emulsion or like. The periodontal chip comprises solution and/or suspension which is comprising of dry powder, granules, beads or the like.

Pongamia pinnata:
The fresh twigs of Pongamia pinnata were authenticated under standard literature and herbarium of P.pinnata SOP/COG/130/2013 from the Medicinal Garden, RK University, certified by the Botanist of School of Science, RK University and was submitted at School of Pharmacy, RK University.

It is a glabrous tree belonging to family Papilionaceae; Fabaceae, commonly known as Indian beech or Pongam oil tree in English, Karanja in Hindi and Gujarati, Naktamaala in Ayurveda and Pongam in Tamil. It has been widely used as folk medicinal plant in Ayurvedic and Siddha system of medicine. It is mainly found in the areas of Western Ghats as well as Indian tidal forests. However, due to its extensive applications, the plant has migrated across all over India.

P. pinnata contains various types of flavonoids and related compounds. Specifically, prenylated flavonoids like furanoflavonols, furanoflavones, chromenoflavones, pyranochalcones and furanochalcones are the major phytochemicals; excluding the recently isolated ones: pongaflavanol and tunicatachalcone from the stem bark, pongapinnol A-D and pongacoumestan from the fruits, pongamones A-E from the stem. However, seeds and its oil contain Karanjin, pongamol, pangolin and kanjone.

Since many years, oil of P. pinnata seeds is used in various skin diseases, in pneumonia and cold; while leaves are used in dyspepsia, flatulence or diarrhoea as well as infusion is given for gonorrhea and leprosy. Its roots are used to clean foul ulcers and to close fistulous sores; stem bark is given internally for bleeding piles. Bronchitis and whooping cough can be treated using the rind of pods and seeds. Additionally, leaf and seed oil is prescribed for its antirheumatic activity. Undoubtedly, it was proved from the modern research that extract of P. pinnata also possesses antimicrobial, anti-inflammatory, antifungal as well as analgesic properties. Apart from these, P. pinnata has also shown anti-cariogenic and anti-bacterial activity on dental plaque. Various parts of P.pinnata possess pharmacological importance for its anti-oxidative, anti-fungal, anti-microbial, anti-parasitic, anti-hyperglycemic, anticonvulsant, anthelmintic, anti-inflammatory, anti-ulcer and immunomodulatory activities.

As per one embodiment, the range of salivary extract of Pongamia pinnata is 0.001 to 10 ml, more preferably the range is 0.001 to 5 ml, most preferably the range is 0.1 to 2 ml.

POLYMERS:
Polymers are used for sustained release and high versatility of the formulation. They are usually not affected by pH which makes them more suitable for the good structure of the formulation. Sustained release polymers helps to deliver drug in a manner to reduce dose frequency and to increase patient compliance.

As per one embodiment, the formulation must comprise one or more sustained release polymers which is selected from Eudragit RL 100, HPMC E50 LV, gelatin, agarose, starch, carrageenans, gellan, chitin, chitosan, alginate, lactice-co-glycolide, collagen, zein, inulin, pectin, microcrystalline cellulose, gaur gum, rosin, polyvinyl chloride, PEG, polyvinyl pyrrolidine, polyacrylic acid, polyethylene oxide, polyethylene glycol, polyvinyl alcohol, Carboxymethyl cellulose, Ethyl cellulose, Hydroxyethyl and hydroxypropyl celluloses, Hydroxypropyl methyl cellulose, Cellulose acetate phthalate, Polyvinyl acetate, Polycyanoacrylate, Polyisobutylene, poly(caprolactone), Polyurethane, Polymethyl methacrylate, Poly hydroxyethyl methacrylate, keratin, albumin, lectins extracted from Ulex europaeus I, soybean, peanut and Lens culinarius, wheat germ agglutinin, chitosan–iminothiolane, poly(acrylic acid)–cysteine, poly(acrylic acid)–homocysteine, chitosan–thioglycolic acid, chitosan–thioethylamidine, alginate–cysteine, Eudragit RS 30 D, poly(methacrylic acid)–cysteine and sodium carboxymethylcellulose–cysteine and poloxomer.

As per one embodiment, preferable sustained release polymer are keratin, Eudragit RL 100, HPMC E50 LV, MCC; most preferably Eudragit RL 100, HPMC E50 LV.

As per one embodiment, each sustained release polymer of the present invention is present in the range from 1 to 20 gm, more preferably 1 to 15 gm, most preferably from 1 to 10 gm.

PLASTICIZER:-
Plasticizer play an important role in oral drug formulations like tablet, capsules, etc. as they are used as film forming agent in order to make the polymer more soft, pliable, to enhance the plasticity of film and to make it more flexible.

As per one embodiment, the formulation must contain atleast one plasticizer which is selected from PEG 400, Glycerin, Acetyl Tributyl Citrate, Polyethylene Glycols, Acetyl Triethyl Citrate, Polyethylene Glycol Monomethyl Ether, Castor Oil, gelatin, Propylene Glycol, Diacetylated Monoglycerides, Sorbitol Sorbitan Solution, Dibutyl Sebacate, Diethyl Phthalate (DEP), Triacetin, Tributyl Citrate, Triethyl Citrate, Phthalic acid esters, DEHP, dioctyl phthalate (DOP), soybean oil, linseed oil, sunflower oil, and fatty acid esters, diisononyl phthalate, diisodecyl phthalate, water, glycerol, xylitol, pullulan, glycerol, propylene glycol, polyvinyl alcohol, sorbitol and maltitol, Triethyl citrate (TEC), Tributyl citrate (TBC), Acetyl triethyl citrate (ATEC), Dibutyl sebacate (DBS) and dibutyl phthalate (DBP).

As per one embodiment, more preferable plasticizer are glycerin, soybean oil, glycerol, PEG 400; most preferably the plasticizer is PEG 400.

As per one embodiment, the concentration range of plasticizer is 0.01 to 10 ml, more preferably 0.01 to 5 ml, most preferably 0.01 to 1 ml.

As per one embodiment, the formulation comprising a vehicle; which is selected from isopropyl alcohol, propylene glycol, water, aromatic water, glycerine, vegetable oil, mineral oils, organic oils, cacao butter, adeps neutralis, PEGs or glycerinated, gelatin, gum, polyethylene glycol 400, squalane, sorbitol solution, octyldodecanol, isopropyl palmitate, ethyl oleate, alkyl benzoate and isopropyl myristate.

As per one embodiment, more preferable vehicle are water, propylene glycol, isopropyl alcohol; most preferably isopropyl alcohol.

As per one embodiment, the concentration range of vehicle is 0.001 to 10 ml, more preferably 0.01 to 5 ml, most preferably 0.01 to 2 ml.

As per one embodiment, the present invention provides the closest resemblance of mode of action of the invention by chewing twigs of P. pinnata.

As per one embodiment, the process of preparing periodontal chip formulation of pongamia pinnata comprising steps of,
a) collecting Pongamia pinnata twigs;
b) washing, air drying and powdering the step (a) material;
c) macerating the step (b) powder into salivary solution;
d) weighing and hydrating Eudragit RL 100 and HPMC E50 LV in isopropyl alcohol overnight;
e) mixing of step (c) and step (d) solution;
f) adding PEG 400 in step (e) solution and sonicating it;
g) lubricating petridish with castor oil;
h) casting the step (f) solution in step (g) petridish and keeping for air drying for 24 hours at 37?;
i) cutting chips from the patches of step (h) and wrapping with aluminum foil and storing at 37?.

As per embodiment, the present invention provides high patient compliance due to biodegradable nature between 6th and 7th hour of usage.

As per one embodiment, the present invention is about providing a periodontal formulation that does not discolour the teeth or does any damage to the enamel of the teeth due to chemical preservatives and abrasive excipients present in other marketed formulations.

The present invention was experimented and illustrated more in details in the following example. The example describes and demonstrates embodiments within the scope of the present invention. This example was given solely for the purpose of illustration and is not to be construed as limitations of the present invention, as many variations thereof are possible without departing from spirit and scope.

EXAMPLES
Example 1:- Collection and Extraction of Pongamia pinnata
The fresh twigs were authenticated under standard literature and herbarium of P.pinnata SOP/COG/130/2013.
a) The sample was collected from the Medicinal Garden, RK University, certified by the Botanist of School of Science, RK University and was submitted at School of Pharmacy, RK University.
b) Step (a) was washed with water, air dried and powdered.
c) The salivary solution was collected by draining method from a healthy individual at normal human temperature;
d) Step (c) was performed as: Nearly 20 ml Luke warm water was retained in oral cavity for 2 min to gather saliva and allowed to drain into a beaker.
e) The procedure was repeated twice.
f) Step (b) was macerated with step (e) for 24 hours at 37 °C.
g) Step (f) was filtered using Whatman filter paper and the filtrate was stored and preserved in centrifuge tubes in dry and cool place for further processes.

Example 2:- Formulation of Periodontal chip without salivary extract
Composition for Sustained release periodontal chip without salivary extract of P.pinnata as in below table
Ingredients P1 P2 P3 P4
Salivary extract of P.pinnata - - - -
Eudragit RL 100 1 g - - 0.6 g
HPMC E50 LV 0.6 g 0.6 g 1 g 1 g
PEG 400 1 ml 1 ml 1 ml 1 ml
Isopropyl alcohol 20 ml 20 ml 20 ml 20 ml

Procedure:-
a) Eudragit RL 100 and HPMC E50 LV were used in different concentrations, as shown in Table from P1 to P4 and formulated;
b) All the batches were accurately weighed and hydrated overnight in isopropyl alcohol;
c) On the next day, PEG 400 was added in the step (b) as a Plasticizer;
d) Step (c) was kept for sonicating for 10 minutes;
e) Lubricating petri dish with castor oil;
f) Step (d) was casted in step (e);
g) Step (f) is kept for air drying for 24 hours at 37 °C;
h) On completion of drying, each Petri dish was checked for visual imperfections and then, square Periodontal chips of 5 mm × 5 mm were obtained from step (f) using cutter;
i) Step (h) was wrapped using aluminum foil and stored at 37 °C before performing evaluation tests.

Example 3:- Formulation of Periodontal chip with salivary extract
Composition for Sustained release periodontal chip with salivary extract of P.pinnata as in below table
Ingredients E51S E52S E101S E102S E201S E202S
Salivary extract of P.pinnata 1 ml 1 ml 2 ml 2 ml 4 ml 4 ml
Eudragit RL 100 1 gm - 1 gm 0.6 gm 1 gm 0.6 gm
HPMC E50 LV 0.6 gm 0.6 gm 0.6 gm 1 gm 0.6 gm 1 gm
PEG 400 1 ml 1 ml 1 ml 1 ml 1 ml 1 ml
Isopropyl alcohol 20 ml 20 ml 20 ml 20 ml 20 ml 20 ml

Procedure:-
a) Pongamia pinnata twigs were collected;
b) step (a) material was washed, dried and powdered;
c) the step (b) powder was into salivary solution;
d) weighing and hydrating Eudragit RL 100 and HPMC E50 LV were hydrated in isopropyl alcohol overnight;
e) step (c) and step (d) solution were mixed;
f) PEG 400 was added in step (e) solution and sonicating it;
g) petridish with castor oil was lubricated;
h) casted the step (f) solution in step (g) petridish and kept for air drying for 24 hours at 37?;
i) cut chips from the patches of step (h) and wrapping with aluminum foil and stored at 37?.

Example 4.1:- Evaluation of Periodontal chip without salivary extract of P.pinnata
Batch P1 P2 P3 P4
Color White white white white
Texture Few air bubbles No air bubbles Few air bubbles Few air bubbles
Thickness 0.45 mm 0.51 mm 0.49 mm 0.53 mm
Weight
uniformity Pass Pass Pass Pass
Folding
Endurance
test 102 36 154 170
Surface
pH 7.2 7.3 7.3 7.2
Tensile
strength 0.025 0.03 0.03 0.028
%
elongation 2.85 2.45 2.3 2.95

Periodontal chips were cut from the patches of all 4 batches and were evaluated for parameters viz. general appearance, thickness, weight uniformity, folding endurance, drug content uniformity, surface pH, tensile strength, % elongation, in vitro dissolution studies and in vitro anti-bacterial activity.
On conducting evaluation of all the 4 batches as per the protocol given in Table were recorded.
Example 4.2:- Evaluation of Periodontal chip with salivary extract of P.pinnata
Batch E51S E52S E101S E102S E201S E202S
Color Very slight yellowish Very slight yellowish Very slight yellowish yellowish yellowish Slightly yellowish
Texture many air bubbles few air bubbles Few air bubbles many air bubbles Few air bubbles Many air bubbles
Thickness 0.61 mm 0.59 mm 0.72 mm 0.74 mm 0.69 mm 0.73 mm
Weight
uniformity Pass Pass Pass Pass pass pass
Folding
Endurance
test 183 137 178 192 142 138
Surface
pH 7.1 7.1 7.2 7.3 7.4 7.4
Tensile
strength 0.04 0.043 0.045 0.038 0.045 0.048
% elongation 2.4 2.5 2.95 3.55 3.8 3.95

Evaluation was conducted as per example 4.1. On conducting evaluation of all the 6 batches as per the protocol given in Table 4 were recorded.

Result: - as per the evaluation performed above, it is found that the batch E101S showed suitable results for formulation selection.

Example 5:- Formulation of periodontal chip of P.pinnata
Below are the compositions and proportions used for the formulation of periodontal chips of P.pinnata.

• Weight of Patch: 3.200 gm
• Number of Periodontal chips (5 mm * 5 mm) obtained from a single patch: 144
• Weight of individual periodontal chip (5 mm * 5 mm): 0.020 gm
• Amount of ingredients used in individual periodontal chip (5 mm * 5 mm):
Ingredients E101S
Salivary extract of P. pinnata 0.012 ml
Eudragit RL 100 6.25 mg
HPMC E50 LV 3.75 mg
PEG 400 0.0062 ml
Isopropyl alcohol 0.125 ml

Example 6:- Swelling index and Biodegradation study
For the evaluation of swelling index and degradation of the periodontal chip, a vial method was employed. A chip of 5 mm × 5 mm was accurately weighed and placed into the vial. The vial was filled with 10 mL phosphate buffer saline of pH 6.8 and the chip was allowed to swell for 8 hours and visual observations were recorded each hour. The chip degraded at the end of the 6th interval, i.e. 7th hour. The swelling index at the end of the 6th hour was calculated by repeating the procedure and weighing the chip.

Swelling index was found to be 2.1%. The study proved that the formulation is biodegradable, which could be indicated for use at night. It is found that the chips when suspended for swelling index, degraded gradually between 6th and 7th hour during observation, which actually proved that the periodontal chip is biodegradable.
,CLAIMS:Claims
We claim,
1. A periodontal chip formulation of pongamia pinnata comprising pongamia pinnata salivary ext., two sustained released polymer, a plasticizer and vehicle.
2. The periodontal chip formulation of pongamia pinnata as claimed in claim 1, wherein the sustained release polymers are selected from Eudragit RL 100, HPMC E50 LV, gelatin, agarose, starch, polyethylene glycol, polyvinyl alcohol, Carboxymethyl cellulose, alginate–cysteine, Eudragit RS 30 D, poly(methacrylic acid)–cysteine and sodium carboxymethylcellulose–cysteine and poloxomer.
3. The periodontal chip formulation of pongamia pinnata as claimed in claim 1, wherein the plasticizer is selected from PEG 400, Glycerin, Castor Oil, gelatin, Propylene Glycol, glycerol and propylene glycol.
4. The periodontal chip formulation of pongamia pinnata as claimed in claim 1, wherein the vehicle is selected from isopropyl alcohol, polyethylene glycol 400, squalane, sorbitol solution, octyldodecanol, isopropyl palmitate, ethyl oleate, alkyl benzoate and isopropyl myristate.
5. The periodontal chip formulation of pongamia pinnata as claimed in claim 1, wherein the pongamia pinnata salivary ext. is present in range from 0.1 ml to 2 ml.
6. The periodontal chip formulation of pongamia pinnata as claimed in claim 1, wherein the each sustained release polymer is present in range from 1 gm to 10 gm.
7. The periodontal chip formulation of pongamia pinnata as claimed in claim 1, wherein the plasticizer is present in range from 0.01 ml to 1 ml.
8. The periodontal chip formulation of pongamia pinnata as claimed in claim 1, wherein the vehicle is present in range from 0.01 ml to 2 ml.
9. The periodontal chip formulation of pongamia pinnata as claimed in claim 1, wherein the process of preparing comprising steps of,
a) collecting Pongamia pinnata twigs;
b) washing, air drying and powdering the step (a) material;
c) macerating the step (b) powder into salivary solution;
d) weighing and hydrating Eudragit RL 100 and HPMC E50 LV in isopropyl alcohol overnight;
e) mixing of step (c) and step (d) solution;
f) adding PEG 400 in step (e) solution and sonicating it;
g) lubricating petridish with castor oil;
h) casting the step (f) solution in step (g) petridish and keeping for air drying for 24 hours at 37?;
i) cutting chips from the patches of step (h) and wrapping with aluminum foil and storing at 37?.

Dated this 17th August, 2022

Documents

Application Documents

# Name Date
1 202121037807-STATEMENT OF UNDERTAKING (FORM 3) [20-08-2021(online)].pdf 2021-08-20
2 202121037807-PROVISIONAL SPECIFICATION [20-08-2021(online)].pdf 2021-08-20
3 202121037807-PROOF OF RIGHT [20-08-2021(online)].pdf 2021-08-20
4 202121037807-POWER OF AUTHORITY [20-08-2021(online)].pdf 2021-08-20
5 202121037807-FORM 1 [20-08-2021(online)].pdf 2021-08-20
6 202121037807-DECLARATION OF INVENTORSHIP (FORM 5) [20-08-2021(online)].pdf 2021-08-20
7 202121037807-EVIDENCE FOR REGISTRATION UNDER SSI [17-08-2022(online)].pdf 2022-08-17
8 202121037807-EDUCATIONAL INSTITUTION(S) [17-08-2022(online)].pdf 2022-08-17
9 202121037807-COMPLETE SPECIFICATION [17-08-2022(online)].pdf 2022-08-17
10 202121037807-FORM 18 [26-07-2025(online)].pdf 2025-07-26