RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

M. PHARM SYNOPSIS
YEAR OF ADMISSION: AUG-2012

TITLE OF THE SYNOPSIS

ADOPTION OF PHARMACEUTICAL TECHNOLOGY FOR CONVERTING

SELECTED THREE HERBAL CHURNAS TO IMPROVE FORMULATION AND
PATIENT COMPLIANCE

BY

Mr. VIBHUSHREE KUMAR T.V.

M. PHARM., PART-I
DEPARTMENT OF PHARMACEUTICS

UNDER THE GUIDANCE OF

Dr. K. MANJUNATH M.Pharm., Ph.D.

Professor,
DEPARTMENT OF PHARMACEUTICS

INSTITUTION
SREE SIDDAGANGA COLLEGE OF PHARMACY,
B. H. ROAD, TUMKUR- 572 102
KARNATAKA.
 CORRECTIONS DONE AS PER THE REMARKS

TITLE OF THE TOPIC:

“ADOPTION OF PHARMACEUTICAL TECHNOLOGY FOR CONVERTING
SELECTED THREE HERBAL CHURNAS TO IMPROVE FORMULATION AND
PATIENT COMPLIANCE”

NAME OF STUDENT NAME OF THE REMARKS THAT HAVE BEEN

GUIDE CORRECTED
VIBHUSHREE KUMAR T.V. Dr. K. MANJUNATH 1) 6.2, et al. has been used indiscriminately.
M. Pharm., Ph. D
Professor & HOD Answer: Corrections are made as per
Dept. of Pharmaceutics suggestion in the section 6.2.

2) The references should be numbered

conservatively in the order in which they are
mentioned in the text.

Answer: One reference is included and all the

references are numbered in the order in which
they are mentioned in the text.

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 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE Mr. VIBHUSHREE KUMAR T.V.

CANDIDATE I M. PHARM
AND ADDRESS DEPARTMENT OF PHARMACEUTICS
SREE SIDDAGANGA COLLEGE OF PHARMACY
B.H. ROAD.
TUMKUR-572 102.
KARNATAKA.

2. NAME OF THE SREE SIDDAGANGA COLLEGE OF PHARMACY

INSTITUTION B. H. ROAD, TUMKUR- 572 102
KARNATAKA.

3. COURSE OF STUDY AND MASTER OF PHARMACY IN PHARMACEUTICS

SUBJECT

4. DATE OF ADMISSION OF AUG 2012

COURSE

5. TITLE OF THE TOPIC

“ADOPTION OF PHARMACEUTICAL TECHNOLOGY FOR CONVERTING

SELECTED THREE HERBAL CHURNAS TO IMPROVE FORMULATION AND PATIENT
COMPLIANCE”

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6. BRIEF REVIEW OF THE INTENDED WORK

6.1 – NEED FOR STUDY

Churnas are fine powder of ayurvedic drug or drugs. Among all ayurvedic dosage forms
churnas are most prescribed dosage forms. Some of the churnas are having large dose,
which makes inconvenience to the patients to swallow. Some of the churnas stick to the
tongue and oral cavity due to inherent adhesive nature. Patients are showing less interest
to take herbal churnas orally because of their astringent, bitter and pungent taste.
Churnas being in powder form also suffer stability due to their hygroscopicity. Triphala
churna is a powder preparation of three myrobalan fruits, (i) Amalaki (Emblica
officinalis Gaertn) (ii) Haritaki (Terminalia chebula Retz) and (iii) Bibhitaki (Terminalia
belerica, Roxb) in equal proportions. It is widely prescribed as a bowel regulator,
purgative, and as an immunity booster1. Triphala formulation is traditionally prescribed
in the form of powder or churna, a powder of equal proportions of dried fruits of all the
three ingredients mentioned above. Ayurvedic formulary of India specifies the dose of
Triphala powder to be 3-6 gm per day2. But swallowing such large amounts of powder is
difficult to the patients.

Sitopladi churna, an Ayurvedic polyherbal formulation consists of (i) Vaushalochan, a

silicious material (Bambusa aurundinacea) (ii) Pippali/long pepper (Piper longum) (iii)
Dalchini (Cinnamomum zeylanicum) (iv) Elaichi/cardamom seeds (Elettaria
cardamomum) and (v) Sarkra (sugar). It is effective in relieving coughs associated with
various respiratory disorders. It also increases the appetite, helps digestion, and provides
strength to the body. It is recommended for seasonal coughs and colds, as it is a very
good expectorant. It is also best supportive in allergic and viral respiratory infection 3.
Dose of sitopaladi churna is 1-3 grams two or three times a day 4. Sitopaladi churna is
given along with half a teaspoon of ghee and a teaspoon of honey. It is even given with
any one of honey or ghee. It is hygroscopic, pungent and sandy taste.

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Hingwastak churna is another Ayurvedic preparation commonly used in the treatment of
Agnimandya (digestive impairment), vataroga (disease due to vata dossha) etc5. It is
prepared with authentic ingredients as follows. Hingu means – Asafoetida, which is the
main ingredient. Ashta means – 8 indicating that this product contains 8 ingredients
namely (i) Sunthi (Zingiber officinale) (ii) Marica (Piper nigrum) (iii) Pippali (Piper
longum) (iv) Ajamoda (Apium leptophyllum) (v) Saindhava Lavana (Rock salt) (vi)
Sveta Jiraka (Cuminum cyminum) (vii) Krsna Jiraka (Carum carvi) (viii) Hing (Ferula
foetida). Dose Hingwastak churna is 3 to 6 gm daily in divided doses 6. It is pungent
bitter taste, irritates and sticks to tongue. Therefore, in the present study we want to
attend to solve some of the problems of above mentioned three herbal churnas.

Bulkiness of herbal formulations shall be reduced by converting the herbal powder into
granules by slugging or compaction methods, hence their density can be improved.
Roller compaction is a dry granulation process used in the pharmaceutical industry to
prepare drug granules with suitable densification, uniform drug content and optimum
powder flowability for manufacturing solid dosage forms such as granules/tablets.
During the roller compaction operation, uniformly mixed powder blends are passed
continuously through the gap between a pair of counter rotating compression rolls to
form solid ribbons or sheets which are then passed through a mill or granulator with a
suitable sized screen to form dry granules. Compared to wet granulation process, dry
granulation by roller compaction has various advantages such as simpler manufacturing
procedure, easier scale up and higher production throughput. Dry granulation is also
energy efficient and suitable for processing pharmaceutical agents that are sensitive to
moisture and heat7. Another technology is to compact the dry powder into large size
tablets (called slugs) using heavy duty compression machines under higher force. The
slugs so prepared without any wet granulating agents are then size reduced to obtain
granules of higher density than original powder.

Taste is an important factor governing the patient compliance. It has gained importance
as the most of the drugs are administered through oral route. Administration of
unpalatable churnas has hampered by their unpleasant taste particularly in case of

pediatric and geriatrics8. Unpleasant taste and odour can be masked by using sweeting

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and flavouring agents. In the development of granules of churnas, influence of various
parameters such as moisture content, inherent binding properties, compaction pressure
on bulk density, reduction in volume of churna per dose, flow properties, physical
stability of granules will be studied.

Hence in the present study, we aimed at conversion of Triphala churna, Sitopladi churna
and Hingwastak churna into stable, palatable and patient acceptable granules to swallow
conveniently by using dry granulation methods and suitable formulations strategies.
Granules will also be formulated with permitted sweeteners, flavors and anti-caking
agents and they will be evaluated appropriately including physical stability studies.

6.2 – REVIEW OF LITERATURE

Tablet formulations of Triphala powder were developed to improve patient compliance and
acceptability by wet granulation technique using maize starch and PVP as binders in the
concentration of 2, 4, and 6%w/w. The granules were evaluated for angle of repose, bulk and
tapped densities and percentage compressibility and the tablets were also evaluated. Bulk
density of the granules was significantly increased with increasing concentration of the
maize starch and PVP. It was concluded that Triphala powder can be prepared in the
form of tablet formulations to improve patient compliance and acceptability9.

An attempt was made to know the suitability of Ayurvedic methods (wet granulation, dry
granulation and direct compression method) and compared the performance
characteristics (weight variation, disintegration, and hardness) of tablets prepared by
Ayurvedic text methods with other methods. It was observed that triphalaguggulkalpa
tablets, prepared by direct compression method, complied with the hardness and
disintegration tests, where as tablets prepared by Ayurvedic text methods failed10.

Roller compaction is a dry granulation process used in the pharmaceutical industry to

create drug granules with suitable densification, drug content uniformity and powder
flowability for manufacturing tablets and capsules. It was found that dry granulation

processing parameters, such as compression force, gap width, roll speed, feeding screw

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speed, granulating screen size, played different roles to the properties of ribbon/sheets
and granule products. The most frequently used excipient for dry granulation
applications is the directly compressible microcrystalline cellulose (MCC). Its fibrous
structure offers excellent compressibility. The influence of excipient composition to the
roller compaction and granulation characteristics was investigated by utilizing spray-
dried filler (lactose monohydrate or mannitol), pregelatinized starch, talc, magnesium
stearate for their studies. Both spray-dried lactose and mannitol fillers formed roller
compacted ribbons with similar solid fraction and tensile strength. However, lactose-
based granules were smaller than mannitol-based granules due to the brittleness of
lactose. Presence of pregelatinized starch caused the noticeable reduction in ribbon solid
fraction, tensile strength and granule size due to the poor compressibility of starch. A
minor content (e.g., 5% w/w) of talc had little effect to the physical properties of ribbons
and granules7.

Roll compaction/dry granulation (RCDG) process was used in the production of directly
compressible excipients, the compaction of drug formulations, the granulation of
inorganic materials and the granulation of dry herbal formulations. The roll compacted
granules exhibited a better flowability in terms of gravimetric and volumetric flow rate11.

In a research trial it was observed that at a compaction pressure of 140 kg/cm 2, the bulk
density of the granulated magnesium carbonate and calcium carbonate was 3.0 and 2.5
times higher than the bulk density of the starting material, respectively. The flowability
of these materials was improved after roll compaction12.

Influence of roll compaction parameters on granules of dry herbal extract from St. John’s
wort was studied. The roll compaction/dry granulation resulted in a larger particle size
and improved the flowability. The incorporation of 2 and 5% magnesium stearate into
the roll compacted extract reduced significantly the sticking of the dry herbals to the
punch faces. In a further study the authors used a 33 factorial design to study the

influence of the amount of magnesium stearate, the roll compaction force and the
granulating sieve size on the mean particle size of granulated extracts and etc. Increasing
the compaction force and the granulating sieve size resulted in increased mean particle

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size13.

Undesirable taste is one of the important formulation problems that are encountered with
many drugs and also it became a key issue for health care providers. Proven methods for
bitterness reduction and inhibition have resulted in improved palatability of oral
pharmaceuticals14. In the literature it was observed that various methods which could be
suitable for taste masking of bitter drugs were described. Some of approaches like
adding flavors and sweeteners, use of lipoproteins for inhibiting bitterness, numbing of
taste buds, coating of drug with inert agents, formation of inclusion and molecular
complexes, solid dispersion system and application of ion exchange resins have been
tried by the formulators to mask the unpleasant taste of the bitter drugs. With application
of these techniques and proper evaluation of taste masking effect one can improve
product preference to a large extent15.

Natural products are often prone to deterioration, especially during storage, leading to
loss of active component, production of degraded products with no activity. These issues
are addressed in order to determine the efficacy of the formulation. Modifications of the
conventional herbal formulations can deal with the stability problems to a large extent.
Stable herbal preparations can be made by addition of calcium silicate. Several problems
arise during the bed drying of herbal extracts, such as bed instability, particle
agglomeration. The addition of drying carriers, like colloidal silicon dioxide to the
extractive solution can minimize these unwanted effects. Some tools such as controlled
storage conditions and techniques like conversion of herbal drugs to novel drug delivery
systems can be used to increase stability of herbal formulations16.

6.3 – OBJECTIVE OF STUDY:

Following are the objectives of the present study

 Collection and size reduction of herbs and determination of the physicochemical
properties of herbal powders.

 To reduce the bulkiness of churns and improve the density.

 To mask nauseous taste and odour of preparation.
 Preparation and evaluation of stable granules of three selected herbal churnas.

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 MATERIALS AND METHODS

Materials
1. For Triphala churna: Myrobalan fruits, Amalaki (Emblica officinalis, Gaertn),
Haritaki (Terminalia chebula, Retz) and Bibhitaki (Terminalia belerica Roxb).
2. For Sitopaladi churna: Vaushalochan, a silicious material (Bambusa
aurundinacea), Pippali/long pepper (Piper longum), Dalchini (Cinnamomum
7.
zeylanicum), Elaichi/cardamom seeds (Elettaria cardamomum), and Sarkra
(sugar).
3. For Hingwastakchurna: Sunthi (Zingiber officinale), Marica (Piper nigrum),
Pippali (Piper longum), Ajamoda (Apium leptophyllum), Saindhava Lavana
(Rock salt), Sveta Jiraka (Cuminum cyminum), Krsna Jiraka (Carum carvi), Hing
(Ferula foetida).
4. Excipients such as binding agents (micro crystalline cellulose, starch), lubricants
(talc, magnesium stearate), disintegrating agents (aerosil, dried starch,
croscarmellose sodium), stabilizing agents/anti-caking agents (magnesium oxide,
aerosol, calcium carbonate), sweeting agents and flavouring agents.

Methods
Dry granulation slugging and roll compaction methods to prepare stable granules.

7.1 - Source of Data

Review of Literature from
a) Journals such as,
 Indian Journal of Pharmaceutical Sciences.
 The Global Journal of Pharmaceutical Research.
 AAPS Pharmarmaceutical Science & Technology.
 European Journal of Pharmaceutics and Bio pharmaceutics.
 International Journal of Pharmaceutical Sciences.
 Journal of Pharmacognosy and Herbal Formulations
 Ayurvedic Pharmacopeia of India (Formulation).
 Ayurvedic Formulary of India.
 International Journal of Research in Pharmaceutical and Biomedical

9
 Sciences.
b) Web sites such as,
 Science direct (www.sciencedirect.com)
 Pubmed (www.ncbi.nlm.nih.gov/pubmed)
 http://www.ccras.nic.in

7.2 - Method of collection of data

 Collection of herbal raw material as per the formula of churnas.
 Size reduction of raw herbs to powder material of them.
 Characterization of herbal powder
1. Organoleptic characteristics.
2. Moisture content.
3. Binding property.
4. Angle of repose.
5. Bulk density.
6. Compressibility index.
 Preparation of granules by slugging and compaction methods using equipments.
 Evaluation of granular properties such as moisture content, bulk density, tapped
density, angle of repose, compressibility index etc.
 Study of influence of formulation aspects such as taste masking, flavours etc.
 Physical stability studies as per ICH guidelines.

7.3 - Does the study require any investigations or interventions to be conducted on

patients or other humans or animals? If so, Please describe briefly.
“NO”

7.4 - Has ethical clearance been obtained from your institution in case of 7.3?
“Not applicable”

REFERENCES

1. Momin M, Amin AF, Pundarikakshudu K. Development and evaluation of tripala

formulation. Ind J Pharm Sci 2004;66(4):427-32.
2. The Ayurvedic Formulary of India, part I, 2nd revised English ed., The Controller
of Publications, Delhi, 2000; pp 110.
3. Priyanka S, Vishal S. Comparative evaluation of Ayurvedic formulation sitopaladi
churna of different brands. The Global J Pharm Res 2012;1(3):398-404.
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 4. The Ayurvedic Formulary of India, part I, 2 nd revised English ed., The Controller
of Publications, Delhi, 2000; pp 116.
5. John A, Gayatri Devi V, Nair RB. Standardisation of Hingwastak churna using
chemical methods J Drug Res Ayurveda Sidda 2006;27(3-4):19-26.
6. Ayurvedic Pharmacopeia of India, (Formulation), part-II, volume-I, 1st ed pp 47-8.
7. Chang CK, Alvarez–Nunez FA, Rinella JV, Magnusson L-E, Sueda K. Roller
8. compaction, granulation and capsule product dissolution of drug formulations
containing a lactose or mannitol filler, starch, and talc. AAPS Pharm Sci Tech
2008;9(2):597-604.
8. Vummaneni V, Nagpal D. Taste masking technologies: an overview and recent
updates. Int J Res Pharm Biomed Sci 2012;3(2):510-24.
9. Patil BS, Bhavik P, Kulkarni U, Ahmad QJ. A study on formulation and evaluation
of Triphala tablets. J Pharmacog Herb Formu 2010;1(1):1-5.
10. Savarikar SS, Barbhind MB, Halde UK, Kulkarni AP. Pharmaceutical and
analytical evaluation of triphalaguggulkalpa tablets. J Ayurveda Integr Med
2011;2(1): 21–5.
11. Kleinebudde P. Roll compaction/dry granulation: pharmaceutical applications.
Eur J Pharm Biopharm 2004;58:317–26.

12. Parrott EL. Densification of powders by concavo-convex roller compactor. J

Pharm Sci 1981;70:288–91.
13. Eggelkraut-Gottanka SGV, Abed SA, Muller W, Schmidt PC. Roller compaction
and tableting of St. John’s Wort plant dry extract using a gap width and force
controlled roller compactor. I. Study of roller compaction variables on granule and
table properties by a 33 factorial design. Pharm Dev Technol 2002;7:447–55.
14. Agrawal VA, Aditya P. Taste abatement techniques to improve palatability of oral
pharmaceuticals: A Review. Int J Pharm Res Dev 2008;2:22-30.
15. Ahire SB, Bankar VH, Gayakwad PD, Pawar SP. Review: Taste masking
techniques in pharmaceuticals. Int J Pharm Sci 2012;3(3):68-82.
16. Thakur L, Ghodasra U, Patel N, Dabhi M. Novel approaches for stability
improvement in natural medicines. Pharmacogn Rev 2011;5(9):48–54.

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9. SIGNATURE OF THE
CANDIDATE

10 REMARKS OF THE Recommended

GUIDE

11 NAME AND
DESIGNATION OF

11.1 Guide Dr. K. MANJUNATH, M. Pharm., Ph. D.

Professor & Head
Department of Pharmaceutics

11.2 Signature

11.3 Co-Guide ( If any) ---------------

11.4 Signature ---------------

11.5 Head of the Dr. K. MANJUNATH, M. Pharm., Ph. D.

Department Professor & Head
Department of Pharmaceutics

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 11.6 Signature

12 12.1 Remarks of the Forwarded to the University for approval

Chairman and Principal

12.2 Signature
(Dr. SURESH V KULKARNI M. Pharm., Ph. D.)
Principal
Sree Siddaganga College of Pharmacy
B. H. Road, Tumkur-572 102.

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