Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 14  |  Issue : 1  |  Page : 66-70

Evaluation of Effect of Simethicone Oral Disintegrating Drug on Salivary Constituent Transformation: A Clinical Prospective Study


Department of Prosthodontics, SRM Dental College, Ramapuram, Chennai, Tamil Nadu, India

Date of Submission24-Mar-2022
Date of Decision28-May-2022
Date of Acceptance03-Jun-2022
Date of Web Publication05-Aug-2022

Correspondence Address:
Dr. Ahila Singaravel Chidembaranathan
Professor, Department of Prosthodontics, SRM Dental College, Ramapuram, Chennai, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jofs.jofs_93_22

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  Abstract 


Introduction The most common problems encountered by human beings are bloating and discomfort due to accumulation of gas in the stomach. The study aimed to evaluate and compare the effect of simethicone sublingual drug on salivary amylase and flow rate before and after ingestion. Materials and Methods: A total of 12 healthy subjects between 20 and 30 years of age with frequent bloating problems and discomfort in the stomach for more than a year were recruited and the subjects with xerostomia, hormonal imbalance, pediatric patients, psychological disturbances, and taking medicines for any other systemic illness like diabetes, blood pressure, spinal cord injury, and autoimmune disorders were excluded from this study. The subjects were ingested one after the breakfast. The salivary samples were collected before the drug was administered and after 1 and 2 hours of postingestion. The salivary amylase level was calculated using biochemical test kit and the salivary flow rate was calculated by physiologic drooling method. Comparison of salivary amylase was done using repeated chi-square test. Results: The cross tabulation showed statistically significant change in salivary amylase level and salivary flow rate before and after ingestion of simethicone after ingestion. Conclusion: There is a significant increase in level of salivary amylase and salivary flow rate after ingestion of simethicone, hence it can be used in completely edentulous xerostomia patients to control bloating and stomach discomfort.

Keywords: Amylase, antifoaming, saliva, simethicone


How to cite this article:
Chidembaranathan AS, Balu D, Gopal VM, Balasubramanium M. Evaluation of Effect of Simethicone Oral Disintegrating Drug on Salivary Constituent Transformation: A Clinical Prospective Study. J Orofac Sci 2022;14:66-70

How to cite this URL:
Chidembaranathan AS, Balu D, Gopal VM, Balasubramanium M. Evaluation of Effect of Simethicone Oral Disintegrating Drug on Salivary Constituent Transformation: A Clinical Prospective Study. J Orofac Sci [serial online] 2022 [cited 2022 Aug 16];14:66-70. Available from: https://www.jofs.in/text.asp?2022/14/1/66/353477




  Introduction Top


Saliva protects the intraoral structures like mucosa, gingiva, and teeth against harmful materials, which moisturizes the mouth and helps in chewing, swallowing, and phonetics; it also minimizes the tissue injury. Saliva aids to sustain the neutral oral pH and source of calcium and phosphate ions to remineralize teeth. Saliva contains enzymes, immunoglobulin-A, lactoferrin, histatins, and defensins, which impart antimicrobial activity. Saliva also facilitates taste and oral stage of digestion cycle. Salivary gland function starts to decline with age and also, the changes in salivary constitution depend upon the age in healthy adult.[1],[2],[3],[4]

Saliva plays a major role in maintaining the health of the oral tissues. Any changes in salivary function may lead to alteration of oral tissues which has greater effect on the patient’s quality of life. Literatures have shown that salivary pH, buffering capacity, and flow rate play important roles in the defense of oral mucosa. When the salivary flow rate is reduced, susceptibility to various oral diseases is enhanced. A decline in salivary secretions leads to dry mouth. The prevalence of xerostomia is escalated with age which is approximately 30% in ≥65-year-old age group adults. Salivary substitutes were used to prevent the ill effects of hyposalivation.[5]

Salivary amylase is the commonly used noninvasive biomarker for evaluation of stress level of an individual.[6],[7],[8] Amylase is a key protein secreted in the saliva as a part of oral host immune response to periodontal disease. It is normally analyzed using commercial kits.[9]

Simethicone, a silicon-based organic polymer, is widely used to treat the conditions of excessive gas due to its anti-foaming properties. Also, it is used to treat diseases like heartburn, gastric ulcer, colic, sensitive bowel syndrome. It is available in various forms like capsule, drop, suspension, chewable tablet.[10],[11],[12],[13] More than 50% of the drug delivery systems available in the market are oral route because of low cost and ease of ingestion which lead to high levels of comfort to the patient.[14]

Simethicone is used as a topical barrier for protection, is used for protection of the mucosa against irritants such as gastric HCl, acetylsalicylic acid, or biliary salts.[15] Simethicone likely acts along with the endogenous surface-active substances of the lining of gut mucosa. The effects of simethicone are interlinked with the intraluminal actions of the compound in the gastrointestinal tract, since it is executed and nontoxic.[16] Therefore, the study was concentrated on the activity of amylase in saliva with the aim of developing a simple quantitative measurement technique to monitor human stress in persons with floating disturbances. Hence, the study was done with the objective to evaluate and compare the effect of simethicone oral disintegrating drug on salivary amylase and flow rate before and after 1 and 2 hours of ingestion of simethicone. A hypothesis was formulated that the salivary amylase level will be the same before and after ingestion of simethicone.


  Materials and Methods Top


The study subjects were randomly recruited from the patients who reported to the Department of Prosthodontics at SRM Dental College, Ramapuram, Chennai, Tamil Nadu, India. A total of 12 healthy subjects between 20 to 30 years of age with male : female ratio 1:1 were included in the study. The exclusion criteria were: xerostomia, hormonal imbalance, pediatric patients, psychological disturbances, and taking medicines for any other systemic illness like diabetes, blood pressure, spinal cord injury, and autoimmune disorders. Ethical approval for this study was provided by Institutional Review Board of SRM Dental College, Ramapuram with protocol number SRMDC/IRB/2022/S/005, SRM Institute of Science and Technology (Deemed to be) University, Chennai on April 30, 2022. The study was conducted after obtaining informed consent from each subject before starting the research.

The oral disintegrating strip of simethicone IP 62.5 mg (Gasofilm sachet, Delvin Pharma, Chennai, Tamil Nadu, India) was made using film technology in a different film technology [Figure 1]. It was administered sublingually after 1 hour of breakfast. The salivary samples were collected before the drug was administered and after 1 and 2 hours postingestion [Figure 2]. The salivary amylase level was calculated using biochemical test kit (Tulip Pharma Pvt Ltd, Ahmedabad, India) and the salivary flow rate was calculated by physiologic drooling method [Figure 3].
Figure 1 Gasofilm.

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Figure 2 Salivary samples.

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Figure 3 Amylase test.

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Statistical analysis

The obtained values were statistically analyzed using the SPSS software (Statistical Package for the Social Sciences v17; IBM, Chicago, IL, USA) Comparison of salivary amylase was done using repeated chi-square test. The P-value < 0.05 was considered as statistically significant.


  Result Top


The relation between the independent variables salivary amylase and salivary flow rate of the subjects before and after 1 and 2 hours of ingestion of simethicone were statistically analyzed using repeated chi-square test [Table 1] and the cross tabulation was done for the obtained data [Table 2]. The significance value P was calculated using two-sided Sig 2 test for the Pearson chi-square test which showed 58 cells (100%) have expected count <5 and the P-value < 0.05. Hence, there was a significant difference in salivary amylase and salivary flow rate before and after 1 hours of ingestion of simethicone [Table 3].
Table 1 Details of clinical caseafter 1 hour of ingestion of simethicone

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Table 2 VAR0003 × VAR0005 count cross tabulation

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Table 3 Chi-square Test for 1 hour ofingestion of simethicone

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The relation between the independent variables salivary amylase and salivary flow rate of the subjects before and after 1 and 2 hours of ingestion of simethicone were statistically analyzed using repeated chi-square test [Table 4] and the cross tabulation was done for the obtained data [Table 5]. The significance was calculated using two-sided Sig 2 test for the Pearson chi-square test which showed 56 cells (100%) have expected count <5 and the P-value < 0.05. Hence, there was a significant difference in salivary amylase and salivary flow rate before and after 2 hours of ingestion of simethicone [Table 6].
Table 4 Details of clinical case after 2hours of ingestion of simethicone

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Table 5 VAR0003 × VAR0006 count cross tabulation

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Table 6 Chi-square Test 2 hours ofingestion of simethicone

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  Discussion Top


Salivary production decreases by about 25% with age (Schofield, 1999)[17] and the tongue, in common with all skeletal muscles, becomes atrophied and the sense of taste becomes less acute. As production of salivary amylase decreases it tends to decrease the digestion of starch in the mouth, but this is unlikely to be significant as starch digestion is completed in the small intestine. The reduced salivation and loss of taste acuity may reduce the joy of eating in an older person compared to in their younger days. This may have consequences for nutrition in the subject. Reduced salivation may lead to xerostomia, which may be present in many older people, especially in older women, and dryness of the mouth may lead to soreness and lesions in the mouth which can further reduce the pleasure of eating. The prevalence of xerostomia increases with age and is approximately 30% in those aged ≥65 years old.[19]

Simethicone, a silicon-based organic polymer, is widely found in drug formulations used in the treatment of conditions caused by excessive gas due to its anti-foaming properties. It is used as an active ingredient or excipient in different drug forms such as capsule, drop, suspension, chewable tablet, and is preferred in the treatment of diseases such as heartburn, gastric ulcer, colic, sensitive bowel syndrome.[10],[11],[12]

Simethicone is an anti-foaming agent that decreases the surface tension of gas bubbles, causing them to combine into larger bubbles in the stomach that can be passed more easily. Simethicone does not reduce or prevent the formation of gas in the digestive tract; rather, it increases the rate of expulsion of gas when it exits in the rumen. Simethicone can relieve pain caused by gas in the intestines by decreasing foaming, which then allows for easier passing of flatulence. Simethicone is not absorbed by the body into the blood stream and is therefore considered relatively safe.[20]

Simethicone is a therapeutic agent for infants and adults to relieve colic pain. It has narrow therapeutic activity which reduces intestinal gas by reducing the transit time in the gut. Also, it is an inert material, hence it would be absorbed in the gastrointestinal tract with no uneventful side effects, so that it can be taken for treating the self-limiting disorder.[21]

The oral route is increasingly used for the delivery of therapeutic agents because the low cost of the therapy and ease of administration lead to high levels of patient compliance. More than 50% of the drug delivery systems available in the market are oral drug delivery systems.[14]

In this study, we monitored the use of an antifoaming agent simethicone. It is administrated sublingually; it is chemically inert mixture of polydimethylsiloxane and silica gel. The drug decreases the surface tension and reduces the gas from gastro intestinal tract (GIT) in patients complaining from recurrent flatulence. It exerts action only on gastro intestinal tract (GIT) as it is not absorbed into blood stream.

Salivary amylase (alpha amylase) hydrolyses large polysaccharides into maltose and glucose. It also acts as stress marker and surrogate matter of sympathetic nervous system. The sample that is collected without administration of drug, an unstimulated sample, shows no increase in the level of salivary amylase and flow rate. While other samples that are evaluated after administration of drug in stimulated method result in increased level of salivary amylase of 0.02 level and also increase in level of salivary flow rate of 0.05 mL for first hour and second hour. Pearson chi-square test was <5 and the P-value < 0.05 was significant. Hence, there was a significant difference in salivary amylase and salivary flow rate before and after 1 and 2 hours of ingestion of simethicone.

Simethicone does not cause any serious side effects and chances for only mild diarrhea and nausea are there.[20] Since simethicone is not absorbed orally, it is logical that systemic side effects such as kidney injury, hypertension, and hyperglycemia do not occur.[23]

The limitations of the study is that the participants are only young adults with limited number of participants, hence further research is needed with ELIZA kits with more sample to evaluate the level of salivary α-amylase in geriatric persons.

Clinical implication

As the drug does not elicit any adverse reaction in the adults and increases the salivary secretion rate, it can be recommended to treat dry mouth in persons wearing complete denture.


  Conclusion Top


The salivary amylase and salivary flow rate had been significantly increased in the healthy persons; hence simethicone can be used as safe anti-foaming drug as well as drug to increase the salivation for elderly completed edentulous patients with xerostomia which will further improve the retention of the denture.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Challacombe SJ, Percival RS, Marsh PD. Age-related changes in immunoglobulin isotypes in whole and parotid saliva and serum in healthy individuals. Oral Microbiol Immunol 1995;10:202-7.  Back to cited text no. 2
    
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Rohman A, Musfiroh A, Wijaya EG. Quantitative determination of simethicone in antacid suspension and chewable tablet using FTIR spectroscopy. Glob J Pharmacol 2013;7:270-5.  Back to cited text no. 10
    
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Rider JA. Experience with the use of defoaming agent in the treatment of gastrointestinal gas. Ann N Y Acad Sci 1968;150:170-7.  Back to cited text no. 11
    
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Mojsiewicz-Pienkowska K. Size exclusion chromatography with evaporative light scattering detection as a method for speciation analysis of polydimethylsiloxanes. III. Identification and determination of dimeticone and simeticone in pharmaceutical formulations. J Pharmaceut Biomed Anal 2012;58:200-7.  Back to cited text no. 13
    
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Aqther A, Kumar BP, Basha P. Formulation and in-vitro evaluation of ornidazole gastroretentive tablets by using low density swellable polymers. Ind J Res Pharm Biotec 2013;5:2320-471.  Back to cited text no. 14
    
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Bergmann JF, Simoneau G, Chanteiair G, Caulin C, Sgrestaa JM. Use of dimethicone to reduce the fall in gastric potential difference induced by bile salts. Eur J Clin Pharmacol 1989;36:379-81.  Back to cited text no. 15
    
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Nair B. Final report on the safety assessment of stearoxy dimethicone, dimethicone, methicone, amino bispropyl dimethicone, aminopropyl dimethicone, amodimethicone, amodimethicone hydroxystearate, behenoxy dimethicone, C24-28 alkyl methicone, C30-45 alkyl methicone, C30-45 alkyl dimethicone, cetearyl methicone, cetyl dimethicone, dimethoxysilyl ethylenediaminopropyl dimethicone, hexyl methicone, hydroxypropyldimethicone, stearamidopropyl dimethicone, stearyl dimethicone, stearyl methicone, and vinyldimethicone. Int J Toxicol 2003;22(Suppl 2):11-35.  Back to cited text no. 16
    
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Schofield P. Alzheimer’s Disease and Brain Reserve. Aust J Ageing 1999;18:2-51.  Back to cited text no. 17
    
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McLaren DS. Response to the fnb supplement on the positive deviance approach to improve health outcomes. Food and Nutrition Bulletin 1999;20:233.  Back to cited text no. 18
    
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Ship JA, Pillemer SR, Baum BJ. Xerostomia and the geriatric patient. J Am Geriatr Soc 2002;50:535-43.  Back to cited text no. 19
    
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Brecevic L, Bosan-Kilibarda I, Strajnar F. Mechanism of antifoaming action of simethicone. J Appl Toxicol 1994;14:207-11.  Back to cited text no. 20
    
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Danhof IE, Stavola JJ. Accelerated transit of intestinal gas with simethicone. Obstet Gynecol 1974;44:148-54.  Back to cited text no. 21
    
22.
Lev-Toaff AS, Langer JE, Rubin DL et al. Safety and efficacy of a new oral contrast agent for sonography: a phase II trial. AJR Am J Roentgenol 1999;173:431-6.  Back to cited text no. 22
    
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Drugs and Lactation Database (LactMed) [Internet]. Simethicone. Bethesda, MD: National Library of Medicine (US); 2006.  Back to cited text no. 23
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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