Prapration of Tablet from Pencil Cactus for Treatment of Piles by Direct Compression method

Abstract

The intention of current review is to make available upto-date information on morphology, ecological biodiversity, medicinal uses, phytochemistry and pharmacological activities on different parts of Euphorbia tirucalli (E. tirucalli). This plant has a number of medicinal uses. Latex of E. tirucalli is vesicant and rubefacient which is used for rheumatism, warts, cough, asthma, ear-ache, tooth-ache and neuralgia. It acts as a purgative in small doses while in big doses it is bitter irritant and emetic. Milky juice is alexiteric, carminative and purgative. It is useful in whooping cough is used in treatment of piles. gonorrhea, asthma, leprosy, dropsy, dyspepsia, enlargement of spleen, colic, jaundice and stone in bladder. The fresh milky juice is good alternative in syphilis and a good application in neuralgia. A decoction of branches is used in gastralgia and colic. Bark is used in treatment of fractures. Poultices prepared from the stem are useful to repair the broken bones. Boiled root liquid acts as an emetic in cases of snake-bite and for infertility in women. The wood is used for rafters, toys and veneering purposes. It is also useful against leprosy and foot paralysis subsequent to childbirth. E. tirucalli is reported to have euphol, ?-sitosterol, euphorbol hexacosonate, cycloeuphordenol, cyclotirucanenol, tirucalicine, tri-methyl ellagic acid, gallic acids, terpenic alcohol. genotoxic/mutagenic, hepatoprotective, insect repellants, immunomodulatory, larvicidal, molluscicidal/ovicidal/piscicidal, myelopoiesis, proteolytic/chitinolytics pharmacological activities. There is a need to isolate dynamic constituents, their biological trial, molecular mechanisms, experimental protection and legalization of therapeutic uses of E. tirucalli. The collected information will be helpful to locate up study protocol for expansion in curative and treat a variety used in treatment of piles., isoeuphorol, taraxasterol, tirucallol, euphorone, euphorcinol, euphorbins, 12-deoxy-4?hydroxyphorbol-13-phenyl acetate-20-acetate, 12, 20- dideoxyphorbol-13-isobutyrate, glut-5-en-3-?-ol, 3,3?- diO-methylellagic acid, euphorbin-A (polyphenol), tirucallin-A (7) (tannin), tirucallin-B (11), euphorbin-F (14) (dimers), cycloartenol, 24- methylenecycloartenol, ingenol triacetate, 12-deoxy-4?-hydroxyphorbol- 13- phenyl acetate-20-acetate, taraxerone, euphorginol, taraxerol, campesterol, stigmasterol, palmitic acid, linoleic acid, ?-amyrin, etc. Active phytoconstituents. E. tirucalli have possessed activity in humanly mphocytes, analgesic, anthelmintics, antiarthritic, antibacterial/antifungal/antimicrobial Antihemerrhoids.

Introduction

I. INTRODUCTION

In  spite  of  great   advances of  modern  scientific  medicine  traditional medicine is still the  primary  form  of  treating diseases of  majority  of people  in  developing countries  including  India;  even  among those to whom  western medicine is available, the  number of  people using one form  or  another of  complementary  of  alternative  medicine  is  rapidly increasing worldwide[1].Over the centuries humans have relied on plants for  basic  needs such as food,  clothing,  and shelter,  all  produced or manufactured from  plant  matrices (leaves, woods, fibers) and  storage parts  (fruits,  tubers)[2].pencil  cactus  plant-have  been   used as  piles treatment. Taxonomic Description In the  binomial  system (USDA plants data at www. plants.usda.gov),

E. tirucalliL. belongs to: Kingdom: Plantae. Division: Magnoliophyta. Class: Magnoliopsida Order: Malpighiales. Family: Euphorbiaceae

Genus: Euphorbia.  Species: E. tirucalli. Binomial name:  Euphorbia  tirucalli Vernacular Names :

Amharic: Kinchib

Arabic: Knjil

English: Finger euphorbia,

Indian spurge tree: milk bush, naked  lady, pencil-tree, rubber  euphorbia, Filipin: Bali bali.

French: Arbre de Saint Sebastien, Euphorbeeffileeuphorbe, Gardemaison, Tirucalli;

Malay: Kayupatah, Tentulang, Tulang, Tulang-tulang;

Somali: Dana; Spanish: Alfabeto  chino, Antena, Esqueleto, Palito, Aveloz; Swahili: Mtupamwitu, Mwasi, Utupa;

Thai: Khiacheen, Khiathian;

II. MATERIAL AND METHOD

A. Material

Euphorbia trirucalli  were  recived   from  mountain.  All other   ingredient such as mannitol. Magnesium stearate and  talc  were  purchased from central  drug   house  new   Dehli,  India.  All ingredients  used  were   of analytical grade.

B. Method

Preparation of tablet  from  euphorbia tirucalli  powder    for treatment of piles.  Other  ingredient  like  lactose  was used as  diluent   magnesium stearate as lubricant and  talc as glidant.  All the excipient along  with API weighed as shown in table  1 and  passed through sieve no 20 . then, all ingredient were  mixed following geometric mixing excluding  glidant  and lubricant thoroughly for 15 min. The powder  blend was thoroughly mixed with talc and magnesium stearate and compressed into a 400 mg tablet using single roatatory machine

III. TECHNIQUES IN DIRECT COMPRESSION

The   processes  involved   in   the   manufacture  of   tablets   by   direct compression method can be summarized in three  steps.

A. Direct  Compression Technique Using   Induced   Die Feeders

This  involves  the   use  of  a  special  feeding  device   which   prevents segregation and enhances the flow of powders from the hopper into the die cavity of a tablet  press. The use of induced die feeder also reduces air  entrapment, making  the  fill powder   more  dense and  amenable to compaction.

Direct  compression technique using induced die  feeder is used when formulation ingredients will compact but  will not  adequately fill the  die cavity.

B. Direct Compression Technique Using Dry Binders

This technique will affect compression of drugs at relatively low filler to drug ratio, with little addition of preparatory techniques.  Materials used as dry  binders  should possess  adequate cohesive  or  compressibility properties in order  to form  satisfactory tablets of acceptable hardness and friability. They should possess adequate flowability and bulk density to  ensure the  die  cavities  are  uniformly  filled  and   hence tablets  of uniform  weight  and  drug  content would  be  obtained. They should also have  high capacity or low binder  to drug ratio in order  to make  possible the   manufacture  of  suitable  sized  tablets  containing  relatively   high doses of drugs.

Examples of  dry  binders used in the  manufacture of  tablet   by  direct compression method include  microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000 etc.

C.  Direct Compression Technique Using Direct Compression Excipients

A direct  compression  excipient  also  referred to  as direct  compressible excipient or  direct   compression  filler/binders  are  inert,  non-medicinal substances which  may  be compacted with no difficulty and  which  may do  so even  when  mixed  with  drug  substances. Direct  compressible excipients should exhibit  satisfactory tabletting characteristics. This is because  they   determine   the   overall   characteristics   of   the   tablet, particularly  in regard to  the  fluidity of  the  component powders. Direct compressible excipients can  also influence the  hardness, disintegration and dissolution characteristics of the finished tablets.

IV. EVALUATION  OF PILES TABLETS

A. Pre-Compressional Studies Of Powder  Blend

In development of  new  dosage form  preformulation study is the  prior step in the potential drug development. It is the principal  investigation in the  drug  development to obtained information on the  known  properties of compound and the proposed development schedule. So, this preformulation  investigation  may   merely   confirm   that   there   are   no significant barriers to compound development. Following pre- compressional  parameters  were   studied  like  angle   of  repose,  bulk density, tapped density, compressibility indices etc

B. Angle Of Repose

It is the maximum angle  that  can  be obtained between the freestanding surface of powder  heap  and  the  horizontal plane.  It was determined by using  fixed  funnel   method.  Specified  amount  of  powder   drug   was transfer to the funnel keeping  the orifice of the funnel blocked by thumb.

When  powder   was cleared  from  funnel   then   measured its  angle   of repose and measured in θ 7 . Angle of repose (θ) = tan-1 h/r Bulk density It is the ratio of bulk mass of powder  to the bulk volume.  It is denoted by ρb. Bulk density is used to find out homogenecity.

Bulk density (ρb) = M/Vb Where, M is the  mass of the  sample, Vb bulk volume

C. Tapped Density

It is the ratio of the weight  of powder  to the minimum volume  occupied in  measuring  cylinder.   Tapped  density  is  determined  by  placing   a graduated cylinder containing a known mass of drug or formulation on a mechanical  tapper apparatus  which  is  operated at  fixed  no.  of  taps (1000)   until  the  powder   bed  reached a  minimum  volume.   8  Tapped density (ρt)  = weight  of  powder   blend/Minimum volume  occupied by cylinder

D. Compressibility Indices

1. Carr’s: Index  Based on  the  apparent bulk density and  the  tapped density, the percentage compressibility  of  the  powder  mixture  was determined  by the following formula.  Carr?s index = Tapped density -Bulk density × 100/ Tapped Density
2. Hausner’s Ratio: It is  an  indirect   index  of  ease of  measuring  of  powder   flow.  Lower Hausner?s  ratio   (1.25).   10  Hausner?s  ratio   =  Tapped  density/  Bulk density

V. POST-COMPRESSIONAL STUDIES OF PREPARED NUTRACEUTICAL TABLETS

The tirucalli tablets were evaluated for various parameters after consideration of preformulation to overcome errors during formulation preparation. These are like appearance, thickness, weight variation, hardness and friability. All the evaluation parameters of all formulations are given in Table 2

A. Physical Appearance

The general appearance of tablet  was studies visually in shape, colour, texture and odour.

Thickness  The  tablet   thickness  was  calculated  by  Vernier  calipers. Tablet  was put  in between two jaws vertically  and  measured thickness and 6 tablets were used for this test and expressed in mm

B. Weight Variation

Weight   variation    test  is   run   by   weighing    20   tablets   individually, calculating the average weight and comparing individual tablet  weight to the average. The weight variation  test would be a satisfactory method of determining the drug content uniformity of tablets.

C. Hardness

Hardness also termed as tablet  crushing strength. The tablet  hardness was determined by Monsanto hardness tester. The  tablet  was placed lengthwise  between  upper   and   lower  plunger   and   force   applied   by turning  a threaded bolt until the tablet  fractures and measured hardness of tablet  in Kg/cm2 7, 8 .

D. Friability

It is determined by Roche  friabilator, subjects a  number of  tablets to combined effects of abrasion and  shock by utilising a plastic chamber that  revolves at  25 rpm, dropping tablet  from  inches distance operated for 100 revolutions. Pre-weighed tablets were dusted and reweighed and according  to  standard  limit  friability  should  be  less  than   1%.  It  is calculated by formula- % Friability = Initial weight  – Final weight  / Initial weight.

E. In-vitro Drug Release

Dissolution profile of eugenol was determined at 37 ± 0.5°C at a stirring rate  of  100  rpm  using the  USP dissolution apparatus II  in 900  ml  of simulated gastric fluid (0.1 N HCl) . Various aliquot  samples were withdrawn with replacement simulated fluid of same amount at 5, 10, 15, 30, 45, and  60 min respectively. Samples were  filtered  using whatmann filter  paper   and   taken   absorbance  at  wavelength  of  366  nm  by  UV spectrophotometer.

VI. RESULTS AND DISCUSSION

The piles  tablet  of  pencil cactus was formulated by direct  compression method. This technique was used for conventional from  pencil  cactus tablet   which  minimize   processing  steps and   eliminated  wetting   and drying process. The physiochemical  property  show satisfactory  results by  pencil   cactus  tablet   which   are   within   the   range   of   prescribed standards required for investigation of present study

A. Pre- Compression Studies Of Powder  Blend

The  powder   blend   was  evaluated  for  various  parameters  and   their results are  shown in Table  2. The evaluation parameters such as angle of repose, bulk density, tapped density, Carr?s index and Hausner?s ratio were    found    to   be   21.12±0.11   to   27.46±0.12   (?),0.4071±0.21   to 0.4741±0.32  g/ml,  0.4132±0.17  to  0.4965±0.028  g/ml,  11.00±0.12  to 14.17±0.39,  1.11±0.012 to  1.17±0.13 respectively.  After  evaluation  of preformulation  parameters  it  showed  that   there   is  no  presence  of moisture in power  and  showed uniformity  of powder  blend  . After study of flow rate  it conclude that  powder  blend exist optimum proportion that leads to maximum flow rate.  So the result showed that  the powder  have good  flowing property  which does not cause affect the process of tablet punching

B. Post-Compression Study

The result from  different physical parameters like thickness, hardness, weight   variation,  and  friability  of  tablets  was  shown in  table   3.  The presence  of   active    pharmaceutical   ingredients,   filler,   glidant    and lubricant is sufficient for provided  bulk to the tablet  which decrease risk during punching. The thickness, hardness, weight  variation, and  friability of pencil  cactus tablet  were  founded to be in acceptable limit. It shows that  the  herbal  drugs containing pencil  cactus tablets have  satisfactory disintegration profile due to their hardness within range  of standard limit

C. Physical Appearance

The general appearance of tablet  was found to be round in shape, brown in color, smooth texture, and odourless.

D. Thickness

The  thickness of  clove  pencil  cactus containing   tablet  for  piles   was found  to be 1.2± 0.1cm. It is depends upon  the size of die and  punches or a function of die fill and compression force.

E. Weight Variation

The  weight   of  20   tablets   was  measured  and   it  was  found   to  be 0.397±0.012  to  0.399±0.034  for  all  formulations  respectively.  All the piles  for     tablet   containing pencil   cactus  powder   passed  weight variation  test as the average percentage weight  variation  was within the USP limits of ±5%.

F. Hardness

The hardness of conventional piles tablet was found to be 4.31±0.21kg/cm2 to 5.21±0.033 for piles containing formulations. Mannitol containing formulation code showed more friable  and  less hardness than  lactose  as diluent.  It is  depend upon  the  compression force  of punching machine and  showed that  it is sufficient for tolerating mechanical strength. Tablets showed sufficiently hard to resist breaking during packaging, shipment and normal  handling.

VII. FRIABILITY

Friability of all formulations was found  to be0.14±0.045 to 0.31±0.0.12 %. The friability of pencil  cactus powder  containing tablet  was found  to be in acceptable limit i.e. less than 1%. There no capping problem occurs in the tablets so it could  be considered for commercial use. It produced no loss during shipping process.

A. Botanical Description

E.  tirucalli   L.  is  a   succulent,  cactus-like  pineless,  unarmed,  much- branched,  monoecious  or  more   often   dioecious,  easy  to  recognize, perennial shrub or tree  up to 10–15 m tall. The rubber-hedge euphorbia reaches usually 2-5 m but may grow up to 15 m on occasion with a 2-4 m spread. The  main  trunk  and  branches are  woody  and  brownish and may thickening

B. Trunk/stem

Diameter of 25 cm.  It grows with single or multiple  trunks. The bark  of very old specimens is grey and  rough  with longitudinal dents and  ridges that    break    up   into   very   small   fragments.  There   are   sometimes conspicuous, small protuberances, such as a bulge, knob, or swelling, on the bark, and occasionally black, rough, crosswise bands.

C. Branches

E. tirucalli  is  a  plant  very  branched with  branches often   arranged in pseudo whorls10 forming  brush-like masses that  are  the  best known feature of  this  species.  Branches:  E. tirucalli  is  a  plant  very branched with  branches often   arranged in  pseudo whorls10  forming  brush-like masses that are the best known feature of this species.

D. Leaves

Leaves are  rarely  seen as they  fall  very  early  and  quickly (early deciduous), tiny, few, simple, fleshy, small or minute, slender and alternate. The leaf  blade  is linear-lanceolate to oblanceolate, 1–2.5 cm long, 3–4 mm broad  and  2 mm thick, acute at tip, tapered to the sessile base, arranged spirally, present only at the tips of young branchlets. The extreme tips  of  young  leafy  branchlets  are  sparsely tomentose,  with curled  brown hairs, and soon glabrescent. Stipules are minute, glandular and  dark  brown.  The function  of the  leaves  is  taken  over  by the  green branches

E. Flowers

Plants are  monoicous or dioicous, the  chromosome number is 20 and  the  diploid number is 2n. The flowers are  small or very small, yellow,  green   or  pink  arranged  in  groups  on  the  terminal  branches, discreet,  and   grouped  at   the   top   of  the   short  branches,  in  heads, stalkless at  the  end  of twigs, and  carried  in clusters at  the  apex  of the short branches or in the angles  branches.

Pencil cactus do produce flowers. They usually bloom  in Spring  and  in summer. You could spot them blooming at the branches’ edges. Those branches would be green  in color.

F. Fruits

Fruits are tripartite capsule and a capsule measures about 8-12 mm in diameter, is subglobose (nearly globose), almost glabrous or glabrescent, longitudinally  very slightly lobed, short-stalked (8 mm), bent  at an angle, pale  gree8n, with a pink tinge  and  conspicuously pubescent (soft hairs).

Capsules dehisce while still on the tree, and exserted on a tomentosepedicelto 1 cm long. Fruits: Fruits are tripartite capsule and  a capsule measures about 8-12 mm  in diameter, is subglobose (nearly globose),  almost  glabrous  or  glabrescent,  longitudinally   very  slightly lobed, short-stalked (8 mm), bent  at  an  angle, pale  green, with  a  pink tinge   and conspicuously pubescent powder prepare in pilesdehisce while still on the tree, and exserted on a tomentosepedicelto 1 cm long.

G. Seeds

The seeds are ovoid (oval), about 3-4 mm x 2.8-3 mm, glabrous, smooth,  buff  speckled  with  brown  and  with  a  dark  brown  ventral  line (with white line), around the small white caruncle 1 mm across.

H. Latex

The latex is a caustic milky white sap when damaged, like many other Euphorbia  specie

VIII. USES OF E. TIRUCALLI

A. Traditional  Medicines

Possibly  due  to  a  great   variety  of  chemical  substances found   in  E. tirucalli tissues (Table II), medical folklore literature of different parts of the  world, especially tropical  and  subtropical areas where  it is endemic, is  tainted  with its  curative  abilities  (Table  III). According  to  Schmelzer and  Gurib-Fakim (7) and  Van Damme  (3), in East Africa, latex  is used in cases of  sexual  impotence,  warts,  epilepsy,  toothache,  hemorrhoids, snake  bites,  for  the   extraction  of  ecto-parasites  and   cough   among others.

Pests and  Disease There  is a tendency to believe  that  E. tirucalli has no pests and disease because of its poisonous latex. However, a few pests including Meloidogyne incognita Botrytis spp. and the weed Cuscuta spp. have been  reported. The latter  that an infestation by Botrytis spp. causes the plant stem and roots to rot especially in warm and humid conditions.

He reports that  a combination of Meloidogyne . that  it is an unavoidable plant in many traditional homesteads whereas it is used as a remedy  for ailments such as: spleen enlargement, asthma, dropsy, leprosy, biliousness, leucorrhoea, dyspepsia, jaundice, colic, tumors, and  bladder stones. He  further  says  that  vesicant  and  rubifacient  though it is,  its latex is emetic in large doses but a purgative in small doses and applied against toothaches, earaches, rheumatism, warts, cough, neuralgia and scorpion bites.

The  same author points out  that  its branch and  root  decoctions are administered for colic and gastralgia while powder  are applied  in piles.

IX. PILES :CAUSE ,TYPE SYMTOMS AND TREATMENT

Ageing has its own advantages and disadvantages. Included in the latter are  piles, clinically known  as haemorrhoids, which  is a condition when veins in your  rectum or  under  the  skin around the  anus swell. These swollen  blood   vessels  can   turn   bowel   movement  into  an   intensely painful  experience. According  to research published in the year 2017  by The Indian Journal of Surgery, half the  men  and  women in India above the  age  of 50 may develop  the  symptoms of haemorrhoids during  their lifetime.  Even though piles are rarely dangerous, if left ignored, they can lead to serious health  complications. In this blog, let’s get a clear picture of the  causes, types, symptoms and  measures that  can  help prevent or cure haemorrhoids.

A. Causes

It is not established yet what actually  causes the veins around your anus to  swell and  bulge, yet  nearly  two  out  of  the  four  adults undergo the symptoms of haemorrhoids. Some  of the  common factors contributing to an  increased risk of suffering from  piles are  constipation, sedentary lifestyle, bad  diet, smoking and alcohol, family history, being  pregnant or obese, regular  heavy eating, and stress.

B. Types

Hemorrhoids are classified into 4 different categories Internal, Prolapsed, External and Thrombosed.

Internal Hemorrhoids: They lie deep  inside the  rectum and  so, are not visible to the naked  eye. They might not cause any pain but  their  presence is marked with  the  symptom of  bleeding through the anus.

External Hemorrhoids: They are  formed in the  outer  lining of the   anal   creating  extreme  discomfort  and   pain.   They  are sometimes invisible and  the  other  times develop  as a  lump. These can  also form  blood  clots within  the  mass that  slips down.

Prolapsed Hemorrhoids: When internal  haemorrhoids swell and sticks outside your anus the  situation is coined  as prolapsed haemorrhoids. These lumps cause discomfort or  pain  along with itchiness and burning.

Thrombosed Hemorrhoids: These swollen bulges around your anus are blood clots within the haemorrhoid tissue. Due to lack of blood supply to your rectal  tissue, thrombosed haemorrhoids need  to be attended to urgently to prevent severe complications.

C. Signs and Symptoms

The symptoms of piles subside on their own in a few days. However, in some  cases,  these  must  not   be   ignored.   Since   ignoring   the   initial symptoms can  lead  to  serious complications, keep  a  check  on  these symptoms:

1. Itching and Bleeding
2. Sore and redness in the anus area
3. Mucus discharge

D. Side Effect of Euphorbia Tirucalli

When taken  by mouth-there is not enough reliable information to know if Euphorbia  hirta is safe.

It might cause side effect such as nausea and vomiting

When  applied  to  the  skin  -There  is  not  enough reliable  information  to know if euphorbia hirta is safe.

It might cause skin irritation or allergic reactions.

E. Special Precaution and Warning

pregnancy-it is possibly unsafe to take Euphorbia  hirta by mouth if you are pregnant. there  is some evidence that it might cause the uterus to contract, and this could cause a miscarriage.

Stomach or intenstinal problem- Euphorbia  hirta can irritate the stomach and intestines. Dont use it if you have a stomach or intestinal  disorder.

Conclusion

From the above study, we conclude that the pencil cactus tablets were prepared by direct compression method and gave satisfactory and acceptable result. Conventional tablet of pencil cactus shows immediate drug release due to direct compressed tablet. The formulation containing pencil cactus could be more beneficial as an effective due to the presence of its cyclotirucanenol , euphol and beta-amyrin containing tablet. From the above research work it was concluded that herbal pencil cactus tablet prepared in the form of cost effective tablet to minimize patients compliance in regarding supressing side effects and enhancing positive effects on the body.

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Copyright

Copyright © 2022 Miss. Chole Laxmi Jalindar, Prof. Bagwan L. R., Dr. Hingane L. D.. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.