A Review on Formulation and Evaluation of Parijat Herbal Tablets Using Natural Disintegrants.

Rheumatoid arthritis (RA) is a systemic auto-immune disease characterized by inflammatory arthritis and extra-articular involvement. It is a chronic inflammatory disorder caused in many cases by the interaction between genes and environmental factors that primarily involve synovial joints. It typically starts in small peripheral joints, is usually symmetric and progresses to involve proximal joints if left untreated.

Joint over time leads to the destruction of the joint with loss of cartilage and bone erosion. RA with a symptom duration of fewer than six months is defined as early RA, when the symptoms have been present for more than six months, it is defined as established RA.

Fig. 1 Rheumatoid arthritis (RA)

Rheumatoid arthritis (RA) is an auto-immune disorder that primarily affects the joints, causing inflammation, pain, stiffness and swelling. It can also affect the other organ in the body. RA occurs when the immune system mistakenly attacks the body's own tissue, particularly the synovium, which lines the joints. Overtime this inflammation can lead to joint damage and deformities. It is a long-term disease, progressive and disabling auto- immune disease.

Types of Rheumatoid Arthritis:

1.Sero-Positive RA

2.Sero-Negative RA

3.Juvenile Idiopathic RA

Etiology: -

1.The cause of rheumatoid arthritis is unknown.

2.It is believed that the tendency to develop may be genetically inherited(hereditary)

3.Smoking tobacco increases the risk of developing rheumatoid arthritis.

4.Environmental influences, such as infections or trauma, are thought to trigger the development of RA.

5.Genetic markers, such as human leukocytes antigen DR4(HLA-DR4), have been associated with triggering the inflammatory process in RA.

Parijat (Nyctanthes Arbor Tristis)

Nyctanthes arbor tristis is one of the most useful traditional medicinal plants in India. It is distributed widely in sub-Himalayan regions and Southwards to Godavari. Each part of the plant has important medicinal properties and is commercially exploitable. It is now considered a valuable source of several unique products for the medicines against various diseases and for the development of some industrial products. The present review is to focus on the potential Phyto-chemicals and pharmacological activity of plant N. Arbortristis. Various parts of the plant like seeds, leaves, flower, bark and fruits have been investigated for their significant pharmacological activity. The plant is used as an herbal remedy for treating various infectious and non-infectious diseases.

Liquorice

Liquorice (Glycyrrhiza glabra L.) belongs to the family – Fabaceae. The name Glycyrrhiza is of Greek origin which means “sweet wood” In Indian medicine Herbal medicine. It is referred to as Mulethi, Malahatti or Yastimadhu. liquorice was extensively subjected to scientific investigations. Liquorice has about 50-100 times sweetness than sucrose in dilute aqueous solution. The major constituents of liquorice are triterpenoids and flavonoids.

Mango Peel Pectin

Mangifera indica contains 16%-20% tannin, namely protocatechuic acid, cynic acid. And catechin, it also contains Mangi ferine, alanine, shikimic acid, astringent and resinous gum. It is used as vermifuges and astringents used in the treatment of rheumatism. Pectin is a heteropolysaccharide formed by D-galacturonic acid. Mango peel pectin can be used as a natural disintegrant,

Fenugreek Mucilage

Trigonella foenum-graecum L. referred as fenugreek, is an herb with medicinal and nutraceutical values which have been described from ancient times in the Indian medicine system. Fenugreek seed mucilage has been explored as a natural disintegrant agent in tablet formulations. They are mucoadhesive polysaccharides and have adhesive properties. This property makes fenugreek mucilage a promising candidate for dosage preparation to enhance disintegration and improve drug absorption.

Several researchers have studied Rheumatoid Arthritis and alternative management approaches:

1.Botanical Description and Phytochemistry: -

(Kirtikar & Basu,1935), Nyctanthes arbor-tristis belongs to the family Oleaceae. The leaves are opposite, ovate, rough, and bitter in taste Phytochemical studies reported the presence of several bioactive constituents such as Tannins, Alkaloids, Saponins. These constituents are mainly responsible for the plant’s anti-inflammatory, analgesic, immunomodulatory, and antioxidant activities

2.Pharmacological Activities of Parijat: -

(Saxena et al., 1984), Several experimental and clinical studies have demonstrated the pharmacological potential of Parijat leaves. Ant-inflammatory and Analgesic activity: Leaf extracts showed significant reduction in inflammation and pain, supporting its traditional use in arthritis. Antipyretic activity: Purser leaf decoction has beno reported to reduce lever partoutarty in malanal and viral levers.

3.Rationale for Herbal Tablet Formulation: -

(Rathore ,2007), Traditional dosage forms like decoctions and powders have limitations such as unpleasant taste. Poor stability, bulky dose, and lack of dose uniformity. Therefore, converting Parijat leaf extract or powder into tablet dosage form is scientifically justified.

4.Use of Natural Disintegrants in Herbal Tablets: -

(Gupta, 2010), Recent literature emphasizes the use of natural disintegrants to replace synthetic excipients. Natural disintegrants are biodegradable, non-toxic, economical, and eco-friendly, commonly reported natural disintegrants include

Parijat leaf powder, Mango peel pectin, Fenugreek (Trigonella foenum-graecum) mucilage.

Aim & Objective

Aim:

Formulation and Evaluation of Parijat Herbal Tablets Using Natural Disintegrants.

Objectives:

1. To formulate herbal tablet containing Parijat (Nyctanthes arbor tristis) extract/powder for therapeutic application.
2. To explore the use of natural, disintegrate (such as Mango pill pectin powder, Fenugreek seed mucilage as alternatives to synthetic disintegrants.
3. To evaluate the prepared tablets for pre-compression parameters (flow properties of powder blend) and post-compression parameters hardness, friability, weight variation, disintegration time, dissolution profiles.
4. To compare the disintegration efficiency of natural disintegrants with that of conventional/synthetic disintegrants.
5. To assess the potential of developing a safe, effective, and eco-friendly herbal dosage form that improves patient Compliance

Methodology of Literature Review

Literature Selection and Data Collection

The present work was conducted as a literature-based review. Data related to herbal oral formulations used for the management of Rheumatoid Arthritis were collected from published research articles, review papers, and clinical studies available in scientific databases. Relevant literature focusing on phytoconstituents, natural disintegrants, formulation requirements, mechanisms of action, and reported efficacy of oral herbal systems was systematically analyzed. Only peer-reviewed sources were considered to ensure reliability and scientific validity.

Requirements for Herbal Oral Systems

Review studies reported that the preparation of herbal oral formulations for anti-inflammatory activity requires specific materials, including Phytoconstituent (Parijat), Natural Disintegrant (Mango Peel Pectin, Liquorice, Fenugreek), binding agents, processing aids, and suitable packaging components. The literature emphasized that proper standardization of phytoconstituent, and inclusion of natural disintegrant and binding agents are critical for achieving stable and consistent oral systems. Additionally, adequate processing equipment, quality control measures, and suitable storage conditions were identified as essential to ensure safety, stability, and effectiveness of oral herbal preparations. The major herbal ingredients reported in the literature for Rheumatoid Arthritis management are summarized in Table 1.

Table 1. Ingredients used in Oral Herbal Formulation

Reported Methodology for Preparation of Herbal Period Pain Relief Topical Systems

The direct compression method is commonly used for commercial manufacture of sublingual tablets. It is a simple and cost-effective process, as it employs ingredients that can be mixed well and do not require further granulation steps prior to lubrication and compression. Sublingual tablets manufactured by the direct compression method exhibit good mechanical strength and acceptably fast disintegration.

The directly compressible sublingual tablet formulation contains directly compressible soluble excipients, a super disintegrant, and lubricant. It may also contain microcrystalline cellulose, dry binder, buffers, surface-active agents, sweeteners, and flavors. Sugar-based excipients are widely used as bulking agents because of their high aqueous solubility, sweetness, pleasant feeling in the mouth, and good taste-masking. Nearly all sublingual formulations incorporate some saccharide-based material (60). The choice of a suitable disintegrant and its amount are critical for achieving a fast disintegration and dissolution rate.

1. Formulation for conventional Tablet: -

• Formulation Table: -

Table 2. Formulation Table conventional Tablet

2. Formulations for Tablet Containing Mango Disintegrant: -

• • • • FORMULATION TABLE: -

Table 3. Formulation Table for Tablet Containing Mango Disintegrant

3. Procedure for Tablet Containing Fenugreek Seed Disintegrant: -.

• Formulation Table: -

Table 4. Formulation Table for Tablet Containing Fenugreek Seed Disintegrant