A PHARMACEUTICAL FORMULATION FOR MAINTAINING HEALTH AND FUNCTION OF DENTAL PULP

Abstract

TITLE: A PHARMACEUTICAL FORMULATION FOR MAINTAINING HEALTH AND FUNCTION OF DENTAL PULP APPLICANT: 1. MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESEARCH 2. MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL ABSTRACT The present invention discloses a pharmaceutical formulation for maintaining health and function of the dental pulp comprises of characterized combination of Carbazochrome Sodium Sulphate, Adrenaline and Carboxyl Methyl Cellulose.

Specification

Description:Form 2


THE PATENT ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)




"A PHARMACEUTICAL FORMULATION FOR MAINTAINING HEALTH AND FUNCTION OF DENTAL PULP"






in the name of MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESEARCH an Indian National having address at NO.12, VEMBULIAMMAN KOIL STREET, WEST K.K. NAGAR, CHENNAI, CHENNAI - 600 078, TAMIL NADU, INDIA., AND MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL an Indian National having address at ALAPAKKAM MAIN ROAD, JANAKI NAGAR, MADURAVOYAL, CHENNAI, CHENNAI - 600 095, TAMIL NADU, INDIA.


The following specification particularly describes the invention and the manner in which it is to be performed.
SOURCE AND GEOGRAPHICAL ORIGIN OF THE BIOLOGICAL MATERIAL:

SL.
NO COMMON NAME SCIENTIFIC NAME PART OF BIOLOGICAL SOURCES SOURCE OF ACCESS DETAILS OF GEOGRAPHICAL LOCATION
1. Cotton Gossypium Lint cultivated (i)Village /Panchayat: Amaravati
(ii) Town/ Taluk: Tenali
(iii) District:
Guntur
(iv) State:
Andhra Pradesh

FIELD OF THE INVENTION:

The present invention relates to the field of dentistry. More particularly the present invention relates to a pharmaceutical formulation for maintaining health and function of the dental pulp.

BACKGROUND OF THE INVENTION:

Dental pulp, surrounded by dentin, supports tooth vitality through the supply of essential factors via apical foramen and plays a key role in tooth maintenance. Through the apical foramen, blood vessels supply nutrients and remove waste products, and the neural network indicates the presence of harmful stimuli through pain. After the progression of dental caries and/or tooth fractures in a tooth crown, a bacterial infection and subsequent inflammatory response of dental pulp occurs, and the internal pressure in the pulp chamber significantly increases, resulting in pulp tissue ischemia with severe pain.

Untreated exposure of pulp to the oral cavity is the cause of pulpitis and pulp necrosis; direct pulp capping or pulpotomy are clinically carried out in order to avoid pulp death. Direct pulp capping with dental materials is used to treat exposed vital pulp to facilitate the formation of reparative dentin. Generally, the most widely used direct pulp capping agents are calcium hydroxide and mineral trioxide aggregate (MTA). In pulpotomy treatment, only the inflamed coronal pulp tissue is removed and the unaffected radicular pulp tissue, which is able to heal, is left in situ. Pulpectomy, also known as a root canal treatment involves removing the nerve and pulp of a tooth and the inside of the tooth is then cleaned and sealed.

There are reports available in the state of art relating to formulation for pulp therapy.

PL230973B1 discloses a product for use in dentistry in the form of a gel, containing sodium hypochlorite and sodium hydroxide, characterized by the fact that it consists of sodium hypochlorite in the amount of 0.9-10.0% by weight, sodium hydroxide in the amount of 0.5-3.0 % by weight, sodium carbonate in the amount of 0.5-3.0% by weight, N, N-dimethyltetradecylamine oxide in the amount of 3.0-30.0% by weight, propylene glycol in the amount of 0.5-5.0% by weight and 50 -90% by weight of water.

US6566418B2 discloses a calcium hydroxide-based root canal filling material having superior bioaffinity is provided, which is a temporary root canal filling material to be used in the root canal treatment of teeth, having such roles that, when filled temporarily in the root canal, it stays in an affected part during a predetermined period of time, thereby a root canal being prevented from staining by pathogenic bacteria or exudates, has corrosion resistance, and promotes the remedy of an apical abscess by wound of the root apex portion. The calcium hydroxide-based root canal filling material is comprised of 3 to 20% by weight of polyvinylpyrrolidone and/or polyvinyl methyl ether, 30 to 60% by weight of calcium hydroxide, and 35 to 60% by weight of water. Further, there is an embodiment in which from 5 to 20 parts by weight of at least one X-ray opacity medium selected from barium sulfate, zirconium oxide, bismuth subnitrate, bismuth trioxide, and bismuth carbonate and/or 0.5 to 5 parts by weight of at least one disinfectant selected from iodoform and iodine is further contained based on 100 parts by weight of the calcium hydroxide-based root canal filling material.

EP2898873B1disclosesdental compositions for treating the pulp and root canals in a tooth. The compositions contain a mixture of particulate materials such as calcium silicate, calcium aluminate, calcium hydroxide, and hydroxyapatite; various organic water-soluble polymeric materials; and surfactants that interact with the polymeric materials.

Though, conventional formulation for pulp therapy exhibits advantages in the prior arts they do have disadvantages such as irritation and damage to the periapical tissues, unpleasant taste and odor, discomfort and poor patient compliance.

Thus there exists a need in the state of art for developing an alternative formulation for pulp therapy.

Hence an attempt has been made to develop a pharmaceutical formulation for maintaining health and function of the dental pulpovercoming the above said drawbacks.


OBJECT OF THE INVENTION:

The main object of the present invention is to provide a pharmaceutical formulation for maintaining health and function of the dental pulp.

Another object of the present invention is to provide a pharmaceutical formulation comprising of characterized combination of Carbazochrome Sodium Sulphate, Adrenaline and Carboxyl Methyl Cellulose.

Yet another object of the present invention is to provide a pharmaceutical formulation for maintaining health and function of the dental pulp with biocompatibility, safe, more patient compliance, ease of application and less irritation.

Further object of the present invention is to utilize the developed pharmaceutical formulation for maintaining health and function of the dental pulp thereby enhancing the effectiveness of pulp therapy procedures.

SUMMARY OF THE INVENTION:

The present invention discloses a pharmaceutical formulation for maintaining health and function of the dental pulp comprises of characterized combination of Carbazochrome Sodium Sulphate, Adrenaline and Carboxyl Methyl Cellulose.

DETAILED DESCRIPTION OF THE INVENTION:

The present invention discloses a pharmaceutical formulation for maintaining health and function of the dental pulp.

The pharmaceutical formulation of the present invention comprises of characterized combination of Carbazochrome Sodium Sulphate, Adrenaline and Carboxyl Methyl Cellulose.The pharmaceutical formulation in which the Carbazochrome Sodium Sulphate is present in an amount of 0.01-0.05% w/w. Adrenaline is present in an amount of 0.001-0.002% w/w,and Carboxyl Methyl Cellulose is present in an amount of 1-3% w/w.

Table 1: Composition of a pharmaceutical formulation for maintaining health and function of the dental pulpof the present invention.

Ingredients Quantity
CarbazochromeSodium Sulphate 0.01-0.05% w/w
Adrenaline 0.001-0.002% w/w
Carboxyl Methyl Cellulose 1-3% w/w

Pulp therapy is used to treat the infected or damaged tooth pulp to preserve the natural tooth structure, especially in children. Traditional methods, like pulpotomy and pulpectomy, often face challenges such as ineffective bleeding control, inflammation, and biocompatibility issues. Incorporating carbazochrome sodium sulphate, adrenaline, and carboxymethyl cellulose (CMC) addresses these limitations. Carbazochrome sodium sulphate ensures rapid hemostasis by stabilizing capillary walls, while adrenaline minimizes bleeding and inflammation through vasoconstriction. CMC acts as a biocompatible carrier, forming a protective layer and improving material application. These ingredients enhance efficiency, safety, and patient outcomes, overcoming the drawbacks of older materials like formocresol.


The pharmaceutical formulation of the present invention is next subjected to experimental studies to ascertain its efficacy in pulp therapy procedures.

Table 2: Experimental Studies

Ingredients Hemostasis increase in % Inflammation reduction in %
pharmaceutical formulation 90 95


The combined use of these components revolutionizes pulp therapy by improving procedural outcomes, patient safety, and long-term tooth health. By ensuring effective hemostasis, reducing inflammation, and offering biocompatible solutions, this combination overcomes the limitations of older materials. The Carbazochrome Sodium Sulphate, Adrenaline and Carboxyl Methyl Cellulose combination makes it particularly suitable for pediatric dentistry. The innovation not only enhances treatment success but also significantly improves the patient experience. This combination marks a major advancement in dental care practices.

The pharmaceutical formulation of the present invention is subjected to synergism studies, to study the effect of the formulation viz-a-viz its components when individually applied.





Table 3: Synergism Studies

Ingredients Hemostasis increase in % Inflammation reduction in %
Carbazochrome Sodium Sulphate 50% 10%
Adrenaline 20% 50%
Carboxyl Methyl Cellulose NIL NIL
Pharmaceutical formulation 90 95

From the results it is inferred that formulation of present invention is effective over individual ingredients.

Advantages:

• The pharmaceutical formulation of the present invention enhances the effectiveness of pulp therapy procedures.
• The pharmaceutical formulation is designed to be less irritating to periapical tissues.
• The pharmaceutical formulation of the present invention is safeand improves patient comfort during and after the procedure.

In one of the preferred embodiments, the present invention shall disclose apharmaceutical formulation for maintaining health and function of the dental pulp comprises of characterized combination of Carbazochrome Sodium Sulphate, Adrenaline and Carboxyl Methyl Cellulose.
As per the invention, the pharmaceutical formulation in which the Carbazochrome Sodium Sulphate is present in an amount of 0.01-0.05% w/w.

In accordance with the invention, the pharmaceutical formulation in which the Adrenaline is present in an amount of 0.001-0.002% w/w.

In accordance with the invention, the pharmaceutical formulation in which the Carboxyl Methyl Cellulose is present in an amount of 1-3% w/w.

Working example:

A pharmaceutical formulation for maintaining health and function of the dental pulp comprised of characterized combination of 0.03% w/w of Carbazochrome Sodium Sulphate, 0.001% w/w of Adrenaline and 2% w/w of Carboxyl Methyl Cellulose.

Although the invention has now been described in terms of certain preferred embodiments and exemplified with respect thereto, one skilled in art can readily appreciate that various modifications, changes, omissions and substitutions may be made without departing from the scope of the following claims.
, Claims:WE CLAIM:

1. A pharmaceutical formulation for maintaining health and function of the dental pulp comprises of characterized combination of Carbazochrome Sodium Sulphate, Adrenaline and Carboxyl Methyl Cellulose.

2. The pharmaceutical formulation as claimed in claim 1 wherein the said Carbazochrome Sodium Sulphate is present in an amount of 0.01-0.05% w/w.

3. The pharmaceutical formulation as claimed in claim 1 wherein the said Adrenaline is present in an amount of 0.001-0.002% w/w.

4. The pharmaceutical formulation as claimed in claim 1 wherein the said Carboxyl Methyl Cellulose is present in an amount of 1-3% w/w.


Dated this 21st day of NOV 2024



For 1. MEENAKSHI ACADEMY OF HIGHER
EDUCATION AND RESEARCH
2. MEENAKSHI AMMAL DENTAL
COLLEGE AND HOSPITAL
By their Patent Agent

Dr.B.Deepa
IN/PA 1477

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