The document discusses herbal formulations and provides details on developing three herbal syrup formulations. It describes conventional herbal formulations like syrups and factors that affect their safety and quality. It then provides the materials and methods for developing 1) a Scoparia dulcis extract syrup, 2) an Achyranthes aspera extract syrup, and 3) a polyherbal formulation syrup combining several herbal extracts. For each, it details the specifications, development process, manufacturing method, proposed dosage, and other quality parameters.

1. Herbal formulations: Conventional
herbal formulations like syrups
Prepared by: Ms. Diksha Choudhary
Master in Pharmaceutical Chemistry
Assistant Prof. at Abhilashi University

2. Herbal formulations:
 A dosage form consisting one or more herbs or processed herb(s) in specified
quantities to provide specific nutritional & cosmetic benefits
 Other benefits meant for use to diagnose treat, mitigate diseases of human
beings or animals and/or to alter the structure or physiology of human beings
or animals
 Herbal preparations are obtained by subjecting herbal substances to
treatments such as extraction, distillation, expression, fractionation,
purification, concentration or fermentation.
 Include comminuted or powdered herbal substances, tinctures, extracts,
essential oils, expressed juices and processed exudates.

3. Factors affecting safety and Quality:
 Quality of starting materials
 Complexity of nomenclature of herbal ingredients
 Chemical contamination by Heavy metals
 Choice of chemical markers
 Adulteration with synthetic chemical drugs

4. Conventional herbal formulations like
Syrups:
 Syrups: aqueous preparations characterized by a sweet taste and a viscous
consistency.
 Contain sucrose at a concentration of at least 45 per cent m/m. The sweet taste
can also be obtained by using other polyols or sweetening agents
 Usually contain aromatic or other flavoring agents
a) Gycerrhiza syrup has been recommended for disguising the salty taste of
bromides, iodides, and chlorides
 Attributed to its colloidal character and its double sweetness of the
glycyrrhizin
 Value in masking bitterness in preparations containing B complex vitamins
b) Acacia syrup because of its colloidal character
 Great value as a particular vehicle for masking disagreeable taste of many
medicaments.
c) Raspberry syrup BP 1088 is one of the most efficient flavoring agents, and is
especially useful in masking the taste of bitter drugs

5. Preservation
 Storage at low temperature
 Adding preservative such as glycerin, benzoic acid, sodium benzoate, methyl
paraben or alcohol in the formulation
 High sucrose concentrations will usually protect an oral liquid dosage form
from growth of most microorganisms
 Combination of alkyl esters of p-hydroxy benzoic acid are effective inhibitors
of yeast that have been implicated in the contamination of commercial syrups.

6. Conventional herbal formulations
MATERIALS AND METHODS:
1. Scoparia dulcis Linn. plant powder extract herbal formulation
2. Achyranthes aspera Linn. plant powder extracts herbal formulation
3. Formulation development for poly herbal formulation

7. 1. Scoparia dulcis Linn. plant powder extract herbal formulation
S.No. Test Specifications
1. Description Clear Green colored syrup
2. Identification
( By HPLC)
In the Assay test, the retention time of the peaks corresponding to
Scopadulcic acid B, Alpha amyrin in the Sample solution matches with the
retention time of the peaks corresponding to Scopadulcic acid B, Alpha
amyrin obtained with Standard solution
3. Weight per ml 1.10 to 1.20 gram per ml
4. pH 2.50 to 3.50
5. Viscosity Between 100 and 210 cps
6. Assay 90.0 % to 110.0 % of label claim
7. Assay of Scopadulcic Acid B,
Sod. Benzoate & Sorbic acid
90.0 % to 110.0 % of label claim
8. Heavy Metals (By AAS) Arsenic : Not more than 2 ppm
Mercury : Not more than 1 ppm
Lead : Not more than 10 ppm
Cadmium : Not more than 0.3ppm
9. Microbiological quality TAMC : NMT 105 (Maximum acceptable count: 500
000) CFU/g or CFU/mL
TYMC : NMT 104 (Maximum acceptable count: 50 000)
CFU/g or CFU/mL
Bile tolerant gram-negative bacteria : 104 CFU/g or
CFU/mL
Escherichia coli : Absence (1g or mL)
Salmonella : Absence (25g or 25mL)

8. Pharmaceutical development:
(10 g) Scoparia dulcis Linn. plant powder (accurately weighed)
Packed in vertical tube
Connected to the RBF (500ml volume) containing 100 ml of 90% ethanol
Placed on heating mental
Having auto control for the temperature selected
90ºC, 1 hour
After completion
Cool & extract was collected aside
Again (50ml) fresh solvent added (RBF) and subjected for same process
Two extractives were mixed and subjected for Rota evaporation until the residue
remained 50ml. The extract obtained was subjected to analysis of the Scopadulcic acid
B and Alpha amyrin content.

9. Developmental pharmaceutics:
 Antidiabetic syrup, combination of 35% w/v sorbitol solution (70% Non crystallizing) with
15% w/v glycerol produced excellent vehicle
 Imparted sweetness to the syrup.
 Vehicle did not have suitable viscosity.
 In order to impart a viscosity to the formulation, hydroxyethylcellulose which is commonly
used as a viscosity-builder was used.
 Natrosol 250 HX PHARM is the commercially available grade of hydroxyethylcellulose.
 Readily dissolves in cold or hot water and gives clear, smooth suspension.
 Used in 0.2% w/v concentration it gave a clear solution without formation of lumps.
 For medicated syrup organoleptic properties such as taste and flavor are important to make it
palatable to patients.
 Plant extract possesses bitter taste which remains persistent after administration.
 Mask this bitter taste saccharin sodium was used as a sweetener since it is approximately 300
times sweeter than sugar and possesses excellent solubility in water.
 Concentration of saccharin sodium was optimized to 0.03 %w/v.
 Apricot flavor was used as flavoring agent.
 Only apricot flavor was used in the concentration of 0.264%v/v it did not mask the bitter taste.

10. Manufacturing process:
Stage 1) Preparation of active solution:
 Dispersed 2.0 g Hydroxyethyl cellulose in 300 ml purified water and allowed to
swell at room temperature for 30 minutes. Added Sodium benzoate.
 Heated the solution to 800C under stirring for 1 hour.
 Allowed the solution to cool to room temperature and added 100ml of plant extract
and Sorbic acid under stirring
Step 2) Preparation of flavor solution:
 Mixture of 0.25 ml Apricot 168153 Flavor and 5 g propylene glycol, 0.15 ml
Peppermint troomint flavor in additional 5 g propylene glycol were prepared
separately.
Stage 3) Preparation of vehicle solution:
 To a mixing vessel added 350 grams of Sorbitol 70% solution.
 Further added 150 grams glycerol to mixing vessel under stirring, rinsed the
container with 50 ml purified water and added it to mixing vessel under stirring.
 Dissolved 0.3 grams saccharin sodium in 10 ml purified water and added to mixing
vessel, rinsed the containers with 10 ml purified water and added to mixing vessel
under stirring.

11. Cont…
Stage 4) Preparation of final syrup:
 Added herbal extract to mixing vessel under stirring. Rinsed the containers with
10 ml purified water and added the rinsing to the mixing vessel under stirring.
Give such 5 consecutive rinsing.
 Cooled the solution to 35-400 C.
 Added solution of Apricot 168153 flavor to mixing vessel under stirring. Rinsed
the container with 20 ml purified water and added to mixing vessel under stirring.
 Added solution of peppermint troomint flavour to mixing vessel under stirring,
rinsed each container separately with 10 ml purified water each and added to the
mixing vessel.
 Made up the volume of syrup with purified water and continued stirring for 15
minutes to get syrup free from lumps, adjusted pH with ortho-phosphoric acid to
get required pH.
Stage 5) Filtration and packing of final syrup:
a) Filtered the syrup through 200 mesh. b) Filled the syrup into bottles.

12. Proposed dosage for administration:
Dosage of Administration for Scoparia dulcis Linn. herbal formulation
 Adult: 30ml / day in 3 divided doses
 Children: 15ml / day in 3 divided doses

13. 2. Achyranthes aspera Linn. plant powder extracts herbal
formulation:
S.No. Test Specification
1. Description Clear green colored syrup
2. Identification
(By HPLC)
In the Assay test, the retention time of the peaks corresponding to
Oleanolic acid solution matches with the retention time of the peaks
corresponding to Oleanolic acid with Standard solution.
3. Weight per ml 1.10 to 1.20 gram per ml
4. pH 3.50 to 4.50
5. Viscosity Between 100 and 210 cps
6. Assay, Assay of Oleanolic acid
Sod. Benzoate & Sorbic Acid
95.0 % to 105.0 % of label claim
7. Heavy Metals
(By AAS)
Arsenic : Not more than 2 ppm
Mercury : Not more than 1 ppm
Lead : Not more than 10 ppm
Cadmium : Not more than 0.3ppm
8. Microbiological quality TAMC : NMT 105 (Maximum acceptable count: 500000) CFU/g or
CFU/mL
TYMC : NMT 104 (Maximum acceptable count: 50 000) CFU/g or
CFU/mL
Bile tolerant gram-negative bacteria : 104 CFU/g or CFU/mL
Escherichia coli : Absence (1g or mL)
Salmonella : Absence (25g or 25mL)

14. Pharmaceutical development
(10 g) Achyranthes aspera Linn. plant powder (accurately weighed)
Packed in vertical tube
Connected RBF (500ml volume) containing 100 ml of 90% ethanol
RBF connected
Heating mantle having auto control(temperature selection)
90ºC, 1 hour
Cool and the extract collected
Again added
50ml of fresh solvent(RBF)and subjected for same process.
Two extractives were mixed and subjected for rota evaporation until the residue
remained 50ml. The extract obtained was subjected to analysis for the content
oleanolic acid.

15. Developmental pharmaceutics (IP, BP, USP)
 Sugar free syrups can be administered by diabetic patients especially, hence the
advantage applied in developing antidiabetic syrup
 Combination of 35% w/v sorbitol solution 70% (non crystallizing) with 15% w/v
glycerol produced excellent vehicle
 Also imparted sweetness to the syrup
 Hydroxyethylcellulose which is commonly used as a viscosity-builder
 Natrosol 250 HX PHARM is the commercially available grade of
Hydroxyethylcellulose
 Readily dissolves in cold or hot water and gives clear, smooth suspension
 Used in 0.2% w/v concentration it gave a clear solution without formation of
lumps
 Components are sparingly soluble in water
 It possesses adequate solubility in propylene glycol, warm water and in acidic
environment.
 pH of formulation was aimed at 2.5-3.5 where it possesses optimum stability

16. Cont…
 For medicated syrups, organoleptic properties such as taste and flavor are important to
make it palatable to patients
 Plant extracts possesses bitter taste which remains persistent even after administration
 Mask this bitter taste saccharin sodium was used as a sweetener
 Since it is approximately 300 times sweeter than sugar and possesses excellent solubility in
water
 Concentration of saccharin sodium was optimized to 0.03 %w/v
 Apricot flavor was used as flavoring agent
 Only apricot flavor was used in the concentration of 0.264% v/v it did not mask the bitter
taste successfully
 A combination of Apricot flavor and menthol was tried
 However, the bitter taste still persisted
 On replacing menthol with Peppermint Troomint flavor in the concentration of 0.1325%
v/v along with Apricot, the bitter taste was successfully masked
 A pleasantly flavored syrup formulation was obtained

17. Manufacturing process:
 The manufacturing process same as mentioned above for Scoparia dulcis Linn.
formulation that herbal extract added was Achyranthes aspera Linn..
Proposed dosage for administration:
Dosage for formulation of Achyranthes aspera Linn. sugar free syrup
Dosage
Adult 30ml / day in 3 divided doses
Children 15ml / day in 3 divided doses
Dosage Administration for formulation of Achyranthes aspera Linn. Sugar free syrup
Dosage
Adult 2 Teaspoonfuls of liquid syrup 3 times daily
Children 1/2-1 Teaspoonful of liquid 1-3 times daily

18. 3. Formulation development for poly herbal
formulation
S.No. Tests Specifications
1 Description Dark green colored syrupy liquid with
characteristic flavor of pineapple, taste sweet.
2 pH Between 4.0 and 6.0
3 Weight per ml Between 1.15 and 1.35 g / ml
4 Viscosity Between 100 and 210 cps
5 Assay of Gallic acid NLT 65.0 mg per 100 ml
6 Assay of Glycyrrhizic acid NLT 120.0 mg per 100 ml
7 Assay of Vasicine NLT 2.0 mg per 100 m
8 Assay of 6-Gingerol
Sod. Benzoate &
Sorbic acid
NLT 2.0 mg per 100 ml
9 Heavy Metals (By
AAS)
Arsenic : Not more than 2 ppm
Mercury : Not more than 1 ppm
Lead : Not more than 10 ppm
Cadmium : Not more than 0.3ppm
10 Microbiological
quality
TAMC : NMT 105 (Maximum acceptable count:
500 000) CFU/g or CFU/mL
TYMC : NMT 104 (Maximum acceptable count:
50 000) CFU/g or CFU/mL
Bile tolerant gram-negative bacteria : 104 CFU/g
or CFU/mL
Escherichia coli : Absence (1g or mL)

19. Components of drug product:
Extracts
 Glycyrrhiza glabra (Yashtimadhu) (Aqueous Extract 5:1)
 Adhatoda vasica (Vasaka) (Aqueous Extract 4:1)
 Terminalia belerica (Vibhitaka) (Aqueous Extract 5:1)

20. Cont…
Step-1:
 In beaker 100ml of purified water was boiled and added the specified
quantity
 Sodium benzoate and sorbic acid and mixed well to dissolve the contents.
To the above added the following duly weighed herbal extracts dry powder
one by one under continuous stirring of the contents in suitable capacity.
 Glycyrrhiza glabra (Yashtimadhu) extract dry powder [5: 1]
 Adhatoda vasica (Vasaka) extract dry powder [4: 1]
 Terminalia belerica (Vibhitaka) extract dry powder [5: 1]
 After addition of dry herbal extracts powder the contents stirred for 1 hour
and kept the solution for maceration for a period of not less than 12 hours.
 Weighed specified amount of propylene glycol BP in a cleaned suitable
capacity of vessel and heated to 70°C to 80°C

21. Cont…
Step-2:
 The Zingiber officinale extract was prepared by process of percolation:
 100g of Zingiber officinale wet material was weighed and subjected for size reduction
of coarse irregular pieces each of 3 mm using knife and packed in percolator (500ml
volume) as a dense bed. Loaded 100 ml of 90% ethanol; remove the locked air, from the
packed bed by allowing the ethanol to drain out from down side, the herbal drug to be
extracted is always covered with the remaining extraction solvent.
 Allowed the whole setup to stand for an appropriate time of 24 hours and collected the
extracted solvent. The residue remained was pressed out and the expressed liquid
combined with percolate. The two extractives were mixed and subjected for rota
evaporation until the residue remained 50ml.
Step-3:
 Filtration of macerated herbals:
 The herbals after completion of maceration were filtered through 200mesh. The
collected filtrate was kept for storage under clean air tight container.

22. Cont…
Step-4:
 Preparation of sucrose syrup: 300ml of purified water was taken in a suitable capacity of
glass vessel & heated up to 55°C temperature, added sodium benzoate and sorbic acid in
sequence, stirred to dissolve for 5 minutes.
 Specified amount of Sucrose was added under constant stirring. Boiled the sugar syrup up
to 90°C and maintain the temperature at 90°C for 30 minutes and stirred well until
Sucrose gets completely dissolved. Then Glycerol BP was added under continuous stirring
for 10 minutes.
Step-5:
 Mixing of extracts solution with sucrose syrup: Filtered the supernatant solution of both
the extracts. Stirred the obtained extracts solution for 5 minutes, boiled the extract solution
up to 70°C. Transferred the boiled extract solution to sucrose syrup. Then added the
zingier extract after reaching temperature of 50ºC and mixed, purified water added up to
required volume.
 Addition of citric acid: Specified amount of citric acid weighed and dissolved in 10ml of
previously boiled purified water in a separate vessel, citric acid solution slowly added with
constant stirring to syrup.
 Addition of color: Specified amount of color BQ supra weighed and dissolved in 20ml of
previously boiled purified water in a separate vessel, and added to bulk syrup.

23. Cont…
 Step-6: Dilution to volume: Measured the volume of syrup obtained, made up to
the required volume with water.
 Step-7: Filtration: Filtered the syrup through 200 mesh to remove any unwanted
particles or lumps after attainment to room temperature.

24. Proposed dosage for administration:
 Dosage of administration for poly herbal formulation:
Dosage
Adult 15ml / day in 3 divided doses
Children 7.5 -15 ml / day in 3 divided doses
Dosage of administration for poly herbal formulation
Dosage
Adult 1 Teaspoonful of liquid syrup 3 times daily
Childern 1/2-1 Teaspoonful of liquid 1-3 times daily
Proposed use: Cough suppressant