International Journal of Nutrition, Pharmacology, Neurological Diseases

ORIGINAL ARTICLE
Year
: 2021  |  Volume : 11  |  Issue : 4  |  Page : 267--273

Formulation and Standardization of Siddha Pediatric Tablet dosage: Bala Sanjeevi Mathirai


Shree Devi Munusamy Sampangi Ramulu1, Parameswaran Sathiyarajeswaran1, Kirubakaran Narayanan1, Soman Vinayak1, Kiruthiga Ganesan2, Kadarkarai Kanakavalli2,  
1 Siddha Central Research Institute (SCRI), Central Council for Research in Siddha (CCRS), Ministry of AYUSH (Govt. of ), Arumbakkam, Chennai, Tamil Nadu, India
2 Central Council for Research in Siddha (CCRS), Ministry of AYUSH (Govt. of ), Arumbakkam, Chennai, Tamil Nadu, India

Correspondence Address:
Shree Devi Munusamy Sampangi Ramulu
Siddha Central Research Institute (SCRI), Central Council for Research in Siddha (CCRS), Ministry of AYUSH (Govt. of India), Arumbakkam, Chennai, Tamilnadu-600106
India

Abstract

Herbal remedies have grown at an exponential rate since ancient times. Traditional medicines require newer standardization, manufacturing, quality control, and scientifically rigorous research to meet standardization. Bala Sanjeevi Mathirai (BSM) is a Siddha pediatric tablet formulation used for the treatment of cough, fever, vomiting, biliousness, and diarrhoea occurring in children due to dyspepsia. This work was purposed to formulate and standardize BSM as per the guidelines set forth by the regulatory authorities (PLIM). Three validation batches of the formulation were prepared. Tablets were standardized by different physiochemical parameters and evaluated by various studies such as precompression and post compression parameters. All parameters were passed with reference to the standard limits. The set parameters were sufficient to evaluate the tablet and further this could be used as reference standards for the quality control/quality assurance laboratory of the pharmaceutical house.



How to cite this article:
Ramulu SS, Sathiyarajeswaran P, Narayanan K, Vinayak S, Ganesan K, Kanakavalli K. Formulation and Standardization of Siddha Pediatric Tablet dosage: Bala Sanjeevi Mathirai.Int J Nutr Pharmacol Neurol Dis 2021;11:267-273


How to cite this URL:
Ramulu SS, Sathiyarajeswaran P, Narayanan K, Vinayak S, Ganesan K, Kanakavalli K. Formulation and Standardization of Siddha Pediatric Tablet dosage: Bala Sanjeevi Mathirai. Int J Nutr Pharmacol Neurol Dis [serial online] 2021 [cited 2021 Dec 3 ];11:267-273
Available from: https://www.ijnpnd.com/text.asp?2021/11/4/267/329198


Full Text



 Introduction



It is noteworthy that AYUSH systems are quickly shifting to a new era of modernization. AYUSH pharmaceutical sector is now drifting to the side and focusing on manufacture and marketing various tablet dosages. Tablets are the unit of fixed solid medicaments prepared by compaction methods such as dry granulation, wet granulation, double compression, and direct compression.[1] They are highly remarked in their low cost of formulation and manufacturing compared to other oral dosage forms. Apart from the product stability, tamper resistance, ease of packaging, and shipping (portability), tablets are now considered the most demanding oral dosage forms compare to all others available in the market.[2]

The approach of tablet manufacture in the AYUSH sector is identical to the contemporary practice, apart from diverse variations in the base materials. It is still an emerging field; nevertheless, the recent trends of tablet dosing in the AYUSH sector that started two decades ago pleased most customer needs. Ease to self-administer, safe to swallow, and comfortable carrying while drifting are the few notable benefits from the end-user.[2] The tablet forms of specific classical formulations of curnam (herbal powders) are highly demanded in the market than the powder form itself; furthermore, from the physician’s point of view, an ideal therapeutic dose or a stable dose of formula is best administered in tablet forms.[1],[2] Tablet forms are the best to the kind intended to be swallowed safely whole where it disintegrates entirely in the gastrointestinal tract and releasing its medicaments.[2]

Siddha medicine, typically acclaimed in India’s southern part, has a different set of dosage formulations in solid, liquid, semisolid, and semiliquid forms.[3] Mathirai or tablet dosages are one of the most preferred oral drug forms in Siddha medical practices.[4] The pharmacopeial works of Siddha medicine endorse the use of curnam (fine powders) prepared out of herbal, animal, and mineral sources as the active material base of a tablet dose.[5] The processed powders or the granules are compressed alone or in cases with a combination of suitable excipients as required depending on the need and target site of disintegration and drug release.[1],[2] There are available protocols for testing and standardization of Mathirai and gulikai published by Pharmacopeial Laboratory of Indian Medicine (PLIM).[5] The guidelines specify organoleptic characterization, weight variation, and disintegration time of the finished product chiefly apart from identification and other toxicologic, microbial, pesticidal, and heavy metal assays. Furthermore, as part of the standardization of tablets to comply with the pharmacopeial limits, both preformulation and finished product should be characterized by specific parameters such as preformulation and postcompression testing to optimize the formulation. It involves physical and bulk characterization, the compatibility studies between drug and excipients, product variation such as weight, thickness, hardness, and friability.[6] The present work was purposed to formulate and characterize the Siddha classical tablet dosage Bala Sanjeevi Mathirai (BSM). BSM is a popular pediatric medicine indicated for cough, fever, vomiting, biliousness, and diarrhea in children due to dyspepsia.

 Materials and Methods



Ingredient details

BSM is a herbomineral blend containing five ingredients [Table 1] and [Figure 1].[4] The ingredients were procured from local country merchants’ herbal traders of Chennai, Tamil Nadu, India. They were authenticated at the Department of Pharmacognosy, and the Department of Animal Mineral Origin Drug Research Laboratory of Siddha Central Research Institute, Arumbakkam, Chennai, Tamil Nadu.{Table 1}{Figure 1}

Formulation of Bala sanjeevi mathirai

The formulation of Pcm involves three stages.Cutti (purification and pre-processing): All the ingredients of herbal and mineral origin were preprocessed and detoxified as per the classical procedures [Table 2].[7],[8]The herbal ingredients cukku, Milaku, and tippili were evaluated for moisture content, extractive value in alcohol, ash value, fluorescence, heavy metals, microbial load, other pathogens, and aflatoxins.{Table 2}Preparation of BSM chooranam (powder for tablet processing): The purified ingredients were finely powdered separately and ground with elumichai caru (lemon juice) for 3 hours. Then dehydrate by drying in shade or a drier [Figure 2].{Figure 2}Formulation of Pcm: The tablet form of Pāla cañcīvi (100 mg) was prepared from BSM chooranam by dry granulation method [Figure 2]. The powder blend was then weighed accurately and passed through sieve #40.

Characterization of Bala sanjeevi mathirai chooranam

Precompression parameters

The powder blends were evaluated for precompression parameters such as bulk density (BD), tapped density (TBD), angle of repose (AOR), compressibility index (CI), and Hauser ratio (HR).[9],[10]

Bulk density: It is the method to evaluate the characterization of a granule to the quantity or mass (in gram) that occupies within an area or volume (in milliliter).[2],[10] BD was measured by pouring the granule drug and additive blend into a measuring cylinder, and the measurement of the initial volume and the weight of the blend were noted. The formula estimates BD:

Bulk density (g/ml) = Weight of the sample (g)/Volume occupied by the sample (ml)

Tapped density: Weighed the quantity of the drug granule, and the additive blend was taken in a measuring cylinder. The volume occupied by the drug and additive blend was noted. Further, the cylinder was subjected to 500 taps initially in a tap density tester. If the percentage volume variation is >2%, it was again subjected to 750 taps or other 1250 taps.[2],[10] TBD is estimated by the formula:

Tapped bulk density (g/cc) = Mass of the powder (g)/Tapped volume of the powder (cc)

Compressibility index: It is the measurement of the free flow property of a powder or granule.[2],[10] The drug powder with the additive blend combination was weighed and transferred into a 100-ml measuring cylinder and subjected to 500,750 and 1250 taps in a tap density tester. The difference between the two taps should be less than 2%. The following formula determined the percentage of CI [Table 3].{Table 3}

Compressibility index % (CI) = Vi0 ‒ Vt1/Vi0 × 100

where Vt1 is the tapped volume and Vi0 is the untapped volume.

Hausner ratio: The ratio indicates the ease of powder flow nature used to understand the degree of compaction of drug and additive combination [Table 3].[2],[10]

Hauser ratio (HR) = Tapped density (TBD)/Bulk density (BD)

Angle of repose: This is a procedure to measure the frictional force of a loose powder. AOR(θ) is obtained by measuring the angle between the free surface of the sample powder heap and the horizontal plane using a manual powder flow tester.[11] It is calculated by the following formula [Figure 3], and the type of flow determines the quality of the powder used for tablet compression [Table 4].{Figure 3}{Table 4}

Postcompression parameters

Tablets of 100 mg were compressed from the herbal powder of Bala Sanjeevi Mathirai chooranam blend using Parle ECO series III tableting machine (ECO III Station D Tooling Rotary Tablet Compression Machine). Then the tablets were evaluated for postcompression parameters.

Weight variation test: Twenty randomly selected tablets of Pcm were weighed separately using a standard weighing balance. The mean weight was estimated, and weight variations were calculated by using the following formula.[9]

Weight variation (in %) = (IW − AW)/AW × 100%

where IW is the individual weight of tablet and AW is the average weight of tablet.

The obtained values were interpreted with the United States Pharmacopeia (USP) limits for the weight variation test for uncoated tablets [Table 5].[9]{Table 5}

Tablet hardness test: Twenty tablets of Pcm were selected for the tablet hardness test using Tab test 401 hardness tester.[9] The width (mm), thickness (mm), diameter (mm), and hardness (N) of each tablet were noted down to estimate the mean value.

Tablet friability test: Several tablets of BSM were weighed and placed in the tablet friability test apparatus, where they get exposed to rolling and repeated shocks as they fall 6 inches in each turn within the apparatus. After 4 minutes of the treatment or 100 revolutions, the tablets were weighed, and the current weight was compared with the initial weight. The loss due to abrasion was considered as a measure of tablet friability. A maximum weight loss of not more than 1% of the weight of the tablets being tested during the friability test was considered generally acceptable, and any broken or smashed tablets were not picked.[9] The value was expressed as a percentage, and the following formula evaluated the friability percentage (FP%).

FP% = [W1 ‒ W2/W1] ×100

where W1 is the initial weight of the tablet sample and W2 is the final weight of the tablet sample after friability test.

Disintegration test:

This test was provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under the specified experimental conditions.[12] The tablets of BSM (six nos) were placed in the disintegration tester to estimate the disintegration time as per IP/USP standards.

 Results and Discussion



The herbal ingredients of BSM were purified as per the traditional standard operating procedure and evaluated for moisture content, extractive value in alcohol, ash value, fluorescence, heavy metals, microbial load, other pathogens, and aflatoxins. The results were within the standard limits [Table 6].{Table 6}

Three batches of granules (BSM A, B, and C) were assessed for precompression parameters like test for AOR(θ), CI (%), and HR. It was found that the flow property of the granule was good enough (mean θ of three samples = 31) as per the standards. The mean CI of 16.98% and HR of 1.19 indicate its flow character to be fair [Table 7] and [Table 8].{Table 7}{Table 8}

The mean weight of 20 tablets was found to be 103.2 mg, and the tablet passed the USP standards of weight variation in %. The friability test reported the maximum weight loss to be 0.32%, an excellent acceptable value. The highest disintegration time of tablets tested was found to be 25 minutes [Table 9] and [Table 10].{Table 9}{Table 10}

 Conclusion



The pediatric tablet dosage, BSM was successfully formulated as per the classical Siddha literature and prepared by direct compression method. The evaluation of granules at different stages of precompression and postcompression reported good results as per the USP/IP standards. Thus, with the approach, a safe, stable, and effective tablet dosage from Siddha medicine has been developed that certifies a delicate balance between mechanical strength and disintegration time. This research emphasized the standardization of Siddha preparation of pediatric tablet dosage form of BSM at laboratory trial level. These research findings will help formulators design further pilot and commercial batches for significant manufacturing aspects of pharmaceuticals with the regulatory guidelines.

Acknowledgment

The authors thank CCRS, Ministry of AYUSH, for providing funding and support for the IMR project (Sanction order No. 237/2017-18) in “A Comparative study on Quality Control Parameters of Mathirai/Tablet formulations used in Siddha System of Medicine”.

Financial support and sponsorship

This study was financially supported for research and publication by Central Council for Research in Siddha for providing.

Conflicts of interest

There are no conflicts of interest.

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