A Comprehensive Review on Formulation and Evaluation of Herbal Tablet

 

Neha S. Ghosalkar*, Mukul S. Malpure, Srushti S. Gode, Aniket S. Gudur

St. Wilfred’s Institute of Pharmacy, Shedung, Panvel, Tal - Panvel, Dist – Raigad (410206), Maharashtra.

*Corresponding Author E-mail: ghosalkarneha04@gmail.com

 

ABSTRACT:

Many health-conscious consumers are opting to use herbal tablets as a dosage form to deliver natural therapeutic agents, which are easy to carry, stable and allow adherence. This review is devoted to the formulation and evaluation of herbal tablets, including the place and challenges of practices and progress in the branches. Some factors related to formulation are taken into consideration, i.e.: the aim of this herbal ingredient, how active fractions are standardized, what role excipients play: binders, disintegrating agents, lubricants, and fillers in tablet development. Another point raised in the article is that of pre-screening which is an important component in evaluating the physical, chemical and biological properties of the plant materials in question, their interaction with other materials, including the assessment of certain problems such as moisture absorbing tendencies and shelf life. Several processes of manufacturing, such as direct compression, wet granulation, dry granulation are described, elaborating on their appropriateness for making herbal tablets. Quality parameters such as hardness, friability, disintegration time, dissolution studies and microbial load testing among others have been included to ensure quality, safety and efficacy of herbal tablets manufactured. This review is helpful for those researchers and practitioners who would like to produce quality, effective, and appealing herbal tablet formulation standards.

 

KEYWORDS: Herbal Tablet, Excipients Role, Pre-screening, Process of Manufacturing, Quality Parameter.

 

 


INTRODUCTION:

A tablet is a solid pharmaceutical dosage form that is made by molding or compression and often contains the medicinal component together with appropriate diluents. The most crucial drug administration technique for systemic effects is oral administration. When addressing medical situations where the patient is unconscious or unable to swallow, as well as when administering different kinds of maintenance medicine, the parenteral route of administration is crucial.

 

Nonetheless, oral administration accounts for about 90% of all medications used to elicit systemic effects. When it comes to oral medications, the solid dose form is the most favored product type. The drug is best protected by a solid dosage form from temperature, humidity, oxygen, light, and stress while being transported. It also guarantees dose accuracy, portability, compactness, blandness of taste, and convenience of administration.

 

Tablet technology has advanced significantly even if the fundamental medical method used to make them has not changed. The physical properties of powder compaction and the variables influencing the medication substance's availability from the dosage form following oral administration are being better understood. both the manufacturing speed and the consistency of the compressed tablets are continuously improving with tableting equipment.

 

Despite frequently having a discoid shape, tablets can also be round, oval, oblong, cylindrical, triangular, and other shapes. Depending on the amount of the excreted material present and the planned mode of delivery, they can differ significantly in size and weight. Depending on whether they are molded or compressed, they fall into one of two broad types. Molded tablets often require small-scale production, while compressed tablets are typically produced on a big scale1.

 

FEATURES OF TABLET:

·       The product should be stylish, unique, and free of flaws including contamination, chips, cracks, and discolouration.

·       It must be strong enough to endure the shocks that are experienced during manufacturing, packaging, shipping, and dispensing.

·       It must possess the physical stability to hold its physical characteristics over time.

·       It must have the ability to release the medication's agent (S) in the body in a consistent and repeatable way.

·       In order to prevent the medicinal agent(s) from being alerted, it must possess appropriate chemical stability over time.

·       Weighting, milling, granulation, drying, blending, lubrication, compression, and coating are among the unit processes needed to manufacture tablets1.

 

TYPES OF TABLETS:

1)    Oral Tablets for Ingestion =· Standard compressed tablet.

·       Multiple compressed tablet: Compression coated tablet/layered tablet/Inlay tablet, Modified release tablet, Delayed action tablet.

·       Targeted Tablet: Floating tablet/colon targeting tablet, Chewable tablet, Dispersible tablet.

2)    Tablets for Oral Cavity= Lozenges and troches, Sublingual tablet, Buccal tablet, Dental cone.

3)    Other Routes of Administration of Tablets= Vaginal tablet, Implant.

4)    Tablets for Preparing Solutions=· Effervescent tablet· Hypodermic tablet, Soluble tablet, Mouth dissolved tablet2.

 

ADVANTAGE OF TABLET3,4,5,6:

1)   Dose accuracy, unit dosage forms.

2)   Least content variability.

3)   Administration possible of small amounts of a drug.

4)   Cheap of all oral dosage forms as its manufacturing does not need any extra processing steps.

5)   Easy transportation.

6)   Enteric coating is one of the techniques utilized to ensure sustained release of a drug.

7)   The coating technique (Sugar coating) is used to mask medicaments having bitter taste.

8)   Tablet dosage form is more stable than all other oral dosage forms.

9)   They are inexpensive and simple to strip and package.

10) Outperforming all oral dosage formulations in terms of chemical and microbiological stability.

11) Fit for production on a wide scale.

12) The coating procedure can cover up unpleasant smells and disagreeable tastes.

13) Enteric coating enables a sustained release product.

 

DISADVANTAGE OF TABLET3,4,5,6:

1)    Giving drugs to children is a challenge.

2)    Drugs that are slowly dissolved is not acceptable that can promote stability of tablets with better bioavailability.

3)    Tablets are not acceptable for this purpose due to the hygroscopic properties of drugs.

4)    Deal with difficulties maintaining the device's chemical and physical integrity over time when it is being stored.

5)    The huge size of the tablet makes swallowing difficult.

6)    Because of their low density and amorphous nature, several medications are resistant to compression into dense compacts.     

7)    It may be challenging to create or manufacture a tablet that will nevertheless deliver acceptable or complete drug bioavailability for drugs with poor wetting, slow dissolution qualities, and optimal absorption high in the GIT.                                                            

8)    Medicines that are sensitive to oxygen, have an unpleasant smell, or are bitter testing medicines can need to be coated or encapsulated. Capsules might be the best and least expensive option in some situations.                                                                           

9)    The GI mucosa is irritated by some substances (like aspirin).                                                                                                         

10) The potential for issues with bioavailability brought on by delayed breakdown and disintegration.

10)

EXCIPIENTES USED IN TABLET6,7:

1)    Diluent:

      Act as bulking agents and make precise dosing easier.

Sugar compounds include cellulose derivatives, calcium, magnesium salt, mannitol, dextrose, sorbitol, silicate, sodium chloride, and potassium chloride.

2)    Granulating agents, compression aid, and binder:

2)Make tablet compression easier. Make sure the tablet is stable.

2)Starch, gelatine, and sugars like lactose, sucrose, glucose, and dextrose are examples of natural and artificial polymers.

3)    Glidants:

      They improve granulation flow, help compress tablets, and prevent particle agglomeration (anticaking).

Talc, silica compounds, and colloidal anhydrous silicon.

4)    Lubricants:

      Decrease the cohesion of the blend during compression and slow down the pace of disintegration. PEG, talc, hydrogenated vegetable oils, steric acid, salts, and steric acid derivatives.

5)    Coating agent:

      Prevent environmental factors (moisture, light, and temperature) that cause tablet breakdown. act as taste-masking substances, disrupt order, make administration easier, and improve appearance.

6)    Disintegrant:

      Promotes the release of the drug component by expanding the surface area of the tablets, which aids in their dissolution and disintegration. Alginates, cellulose derivatives, crospovidone, and starch are among the substances that swell when exposed to water.

7)    Superdisintegrant:

      Superior disintegrant effectiveness that reduces usage in comparison to conventional disintegrants sodium starch glycolate, and croscarmellose.

Manufacturing Technique of Tablet8:

1)    Direct Compression Method: This method eliminates the need for pretreatment by pressing the tablets straight into the medication mixture and tools. Pretreatment like wet acne is not necessary because the compressed mixture should have sufficient flow regions and compact under pressure. Not many medications can be immediately turned into tablets of a suitable grade. The disintegrant type and component are crucial. Particle size distribution, contact angle, pore size distribution, tablet hardness, and water absorption capacity are other variables to take into account. The dispersion is determined by each of these elements. At an industrial level, disintegrant enhancement technology is both costly and simple to utilize.

 

Figure 1. Direct Compression Method

 

2)    Wet Granulation Method: The most popular and extensively utilized technique is the wet granulation process. This process entails a number of phases, including ingredient weighing, mixing, granulation, damp pass screening, drying, lubrication, and tablet compression. After blending the primary active component, diluent, and disintegrant, the mixture is permitted to flow through a sieve (sifting). The original mixture is stirred as binding agent solutions are added. To prevent the pill from becoming overly wet, an adequate amount of binding agent should be applied [46–60]. The granules will be overly soft and prone to breaking down during lubrication if the powder is not adequately wetted, making it challenging to crush the tablet.

 

Figure 2. Wet Granulation Method

 

3)    Dry Granulation Method: Slugging may be employed to create the granules in this method of tablet manufacturing if the components are extremely sensitive to moisture or cannot withstand high temperatures during drying. Dry granulation, also known as twofold compression, typically removes a number of processes that require slugging the powder material. To create the slug, the lubricant, diluent, and active substance are combined. As a result, the compressed slug is run through a mill or mesh, and the leftover lubricant is mixed into the granulation and crushed to create the tablets.

 

Figure 3. Dry Granulation Method

 

Evaluation of parameter:

1)    Pre-compression parameter:

·       Angle of repose:

It is the greatest angle that can exist between a powder pile's surface and the horizontal plane. A powder blend that had been precisely weighed was placed in the funnel. The funnel was raised or lowered until its tip just touched the top of the powder mixture. The powder mixture was permitted to freely flow to the top of the funnel. Using the provided formula, the powder cone's diameter was measured and its angle of repose was computed9.

θ= tan -1 (h/r)

 

Figure 4. Angle of Repose

 

·       Loose bulk density:

·As defined, loose bulk density was by taking a sufficiently weighed amount of powder in the measuring cylinder. The initial volume occupied by the powder is recorded. It is defined as the ratio of weight of powder in grams to the loose bulk volume (cm3)10.

·

                                                     Weight of Powder

Loose of bulk density (LBD) = ---------------------------

                                                         Bulk Volume

 

·       Tapped density:

·It is the ratio of the powder mass to the tapped powder volume. The required amount of the powder blend was placed in a 100ml graduated cylinder and vibrated for a specific number of taps until the volume of the powder bed reached a minimum Tapped density based on the following formula11.

·

                                Weight of Powder

Tapped Density = ---------------------------

                                   Tapped Volume

 

·       Hausner's ratio:

·Hausner's ratio, which measures how easy it is for powder to flow, is computed using formula12.

 

Hausner ratio=Tapped density / bulk density

 

·       Carr's Index (CI): The Carr's index of a material can be estimated using bulk and taped density measurements. Carr's index was calculated using formula12.

 

Tapped density - bulk density / Tapped density * 100 is C.I. (%)

 

2)    Post Compression Parameter:

·       Test of hardness: The Pfizer hardness tester was used to measure the pills' hardness. The tablet is squashed between the holding anvils and the piston that is attached to the direct force reading gauge when the pliers handles are squeezed. By hitting the zero button, the dial indicator returns to zero, but it stays at the reading where the tablet breaks. Five tablets' average hardness was noted13

 

Figure 5. Pfizer Hardness Tester

 

·       Measurement of thickness: A Vernier Calliper that had been calibrated was used to measure the tablets' thickness. Each formulation's three tablets were chosen at random, and each tablet's thickness was measured separately14.

 

Figure 6. Vernier Calliper

 

·       Weight variation: An average weight was determined when twenty tablets were chosen at random. After that, each tablet was weighed separately, and the weight of each was compared to an average15.

 

Figure 7. Weighing Balance

 

·       Test for friability: The Roche Fribilator was used to test the friability of six tablets from each batch. The device was operated for four minutes at a speed of twenty-five revolutions per minute. After removing, dedusting, and reweighing the tablets, the percentage of friability was determined16.

·

% Friability = (Weight loss/Started weight) x 100

 

Figure 8. Friabilator

 

·       Disintegration of tablets: In order to conduct the interruption test, the test device was utilized; six tablets were stored within the device. It took a long time for the shot to break after the medium (simulated stomach fluid, 0.1 N HCL) was heated to 37±0.2 °C17.

 

Figure 9. Disintegration Apparatus

 

·       Drug release investigations conducted in vitro: The USP dissolving rate test apparatus-II (Electro lab, Mumbai, India) was used to conduct the drug release study. The drug release was monitored for 12 hours at 37°C and 50 rpm in 900 cc of pH 6.8-phosphate buffer. After a proper dilution, five millilitres of the sample were extracted at various intervals, filtered, and the drug content was measured at 226 nm17.

·

CONCLUSION:

Tablets are the traditional dosage forms when compared to other oral dosage forms. It is essential for pharmaceutical manufacturers to create a specific drug entity in a new and enhanced dosage form that offers good bioavailability. Each batch of tablets must go through the evaluation tests mentioned above before being released into the market.

 

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Received on 13.12.2024      Revised on 06.01.2025

Accepted on 22.01.2025      Published on 27.02.2025

Available online from March 05, 2025

Asian J. Pharm. Tech. 2025; 15(1):90-94.

DOI: 10.52711/2231-5713.2025.00015

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