FIELD OF THE INVENTION
The present invention pertains to a taste masked and stabilized pharmaceutical composition
comprising clindamycin or a pharmaceutically acceptable salt(s), hydrate(s), solvate(s) and
physiologically functional derivative(s) and precursor(s) thereof; which includes all
polymorphic forms, whether crystalline or amorphous, said composition comprising
polyhydric alcohol(s) and the process for preparing it.
BACKGROUND OF INVENTION
The antibiotic Clindamycin (Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl- trans-4-propyl-L-
2-pyrrolidinecarboxamido)-l- thio-L- threo--D- galacto-octopyranoside) and its
pharmaceutically acceptable salts were originally disclosed and claimed in US patent
3,580,904 (US'904). The US '904 patent also exemplify a pharmaceutical antibacterial syrup
preparation and a method of using it to treat antibacterial diseases. The US patent 3,655,885
discloses the pediatric syrup formulations for treating lincomycin suseptible bacterial
infections.
Clindamycin is a lincosamide antibiotic. It is a semisynthetic antibiotic produced by a 7(S)-
chloro substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
Clindamycin is used primarily to treat infections caused by susceptible anaerobic bacteria,
including infections of the respiratory tract, septicemia and peritonitis. Clindamycin is also
used to treat aerobic bacterial infections and also used to treat some protozoal diseases, such
as malaria.
Oral administration constitutes a preferred route for administering Clindamycin. This route is
convenient and acceptable to the patients. Conventional dosage forms like tablet, pill, and
capsule constitute the solid dosage forms for oral administration. Unfortunately, such
formulations may be associated with certain disadvantages such as administering drug
formulations to pediatric and geriatric patients, who either may dislike such compositions or
may have problem in swallowing. In such situations, oral liquid dosage forms are the
preferred choice. However, these dosage forms usually lead to perceptible exposure of the

active drug ingredient to the taste buds, which is a very serious problem when the drug has an
extremely unpleasant or bitter taste.
The unpleasant taste of the drugs, which are orally administered, is disadvantageous in
several aspects. Taste is an important parameter governing the compliance. The disagreeable
and unpleasant taste of drugs causes difficulties in swallowing or causes patients to avoid
their medication, thereby resulting in low patient compliance. Thus taste-masking
technologies are considered important and are developed by many researchers.
US 6,806,256, describes a taste masked oral solution for quinolone-carboxylic acid antibiotic
containing sucralose, sugar sweetener and at least one flavoring agent.
US20080008765 describes taste-masked composition for oral administration of ready to use
suspension containing coated particles in a suspension base.
US 5,730,997 describe an oral liquid formulation for antitussives, antihistamines,
decongestants, expectorants and mixtures thereof using a high osmolarity system.
Clindamycin like many drug substances has an inherently unpleasant taste (taste and after
taste) and odour. This constitutes a significant disadvantage with the existing oral liquid
compositions. It is a well-known fact that patients' compliance is low when oral preparations
are presented with unpleasant taste and odour.
Artificial flavorings and sweeteners have often been used to mask the taste by generally
overwhelming the taste of the pharmaceutical. However, these are often inadequate and the
bitter taste remains as a lingering after taste. Other methods of masking the taste include
coating the drug with a polymeric material such as ethyl cellulose or an oil, lipid or wax such
as paraffins, waxes, beeswax, higher fatty acids, higher fatty acid esters, glycerin fatty acid
esters or lecithin, so as to create a barrier and delay the dissolution of the drug. These
methods however suffer from the disadvantage of process and formulation complexity and
though sometimes suitable for solid dosage forms, in liquid formulations the drug is usually

solubilized sufficiently to impart an unpleasant taste. For many drugs, there is an unpleasant
taste when dissolved in water-based formulations. Oil-based vehicles are generally not
satisfactory for the reason of poor mouth feel and risk of altered bioavailability.
Numerous liquid pharmaceutical compositions for oral administration of clindamycin have
been proposed, however there still exists a need for stabilized clindamycin composition with
improved tatse, and odour for oral administration with good patient compliance and
acceptance, especially for children.
Clindamycin is available in the form of oral solution under the brand name of Cleocin
pediatric® for pediatric patients in the dose of 75mg/5ml.
We have now surprisingly found that the unpleasant taste and odour of clindamycin could be
substantially improved by the addition of an effective amount polyhydric alcohol in the
composition while still maintaining the stability of the composition.
Further the invention provides simple and cost effective manufacturing methods for
producing clindamycin composition(s) with good stability and organoleptic properties, and
reduction in the total solid content of the composition compared to the marketed formulation.
Thus the invention provides composition(s) of clindamycin with an improved taste;
substantially reduced unpleasant odour, and a pleasant mouth feel with substantially
unchanged bioavailability using cost effective manufacturing methods.
OBJECT OF THE INVENTION
A taste masked pharmaceutical composition of clindamycin, or a pharmaceutically
acceptable salt(s), hydrate(s), solvate(s) and physiologically functional derivative(s) and
precursors thereof, which includes all polymorphic forms, whether crystalline or amorphous
comprising polyhydric alcohol(s); and one or more other pharmaceutically acceptable
excipient(s).

Another object of the present invention is to provide a taste masked pharmaceutical
composition of clindamycin, wherein the amount of active (free base) is more than about 8%
by weight of total solid content of the composition.
Another object of the present invention is a process for preparation of a taste masked
pharmaceutical composition of clindamycin or a pharmaceutically acceptable salt(s) thereof
the said process comprising the steps of a) dry mixing clindamycin, polyhydric alcohol and
other pharmaceutically acceptable excipient(s) to get a dry mixture; b) granulating the dry
mixture above with a granulating liquid prepared by mixing the suitable pharmaceutically
acceptable excipient(s) with aqueous /non-aqueous fluid to obtain a wet mass; c) drying the
wet mass to obtain the discrete particles; d) lubricating the discrete particles obtained with a
suitable lubricating agent and/or flavour(s).
Another object of the present invention is a process for preparation of a taste masked
pharmaceutical composition of clindamycin or a pharmaceutically acceptable salt(s) thereof
the said process comprising the steps of a) melting polyhydric alcohol and mixing with
clindamycin and one or more other pharmaceutically acceptable excipient(s) properly to
obtain a uniform mass; b) further processing the obtained uniform mass to obtain discrete
particles; c) lubricating the discrete particles obtained with a suitable lubricating agent and/or
flavour(s).
DETAILED DESCRIPTION OF THE INVENTION
The present invention pertains to a taste-masked pharmaceutical composition of clindamycin,
or a pharmaceutically acceptable salt(s) thereof, said composition comprising polyhydric
alcohol and one or more other pharmaceutically acceptable excipient(s).
The pharmaceutical composition of the present invention preferably contains polyhydric
alcohol(s), flavoring agent(s) sweetening agent(s), and combinations thereof to improve the
inherently unpleasant taste and odour associated with clindamycin, and thereby improving
the palatability of the present invention.

The term "clindamycin " as used is the invention is meant to cover clindamycin in the form
of freebase or its pharmaceutically acceptable salt(s), hydrate(s), solvate(s) and
physiologically functional derivative(s) and precursors thereof. The term also includes all
polymorphic forms, whether crystalline or amorphous.
Clindamycin may be used as a single active agent, or may be combined with other active
agents, vitamins, minerals, dietary supplements, etc. As used herein, "pharmaceutically
acceptable salts" refer to derivatives of the clindamycin wherein clindamycin is modified by
reacting it with an acid or base as needed to form an ionically bound pair. Examples of
pharmaceutically acceptable salts include conventional non- toxic salts or the quaternary
ammonium salt of the parent compound formed, for example, from non-toxic inorganic or
organic acids. Suitable non-toxic salts include those derived from inorganic acids such as
hydrochloric, hydrobromic, sulfuric, sulfamic, phosphoric, nitric, and others known to those
of ordinary skill in the art. The salts prepared from organic acids such as amino acids, acetic,
propionic, succinic, glycolic, stearic, lactic, malic, tartaric, citric, ascorbic, pamoic, maleic,
hydroxymaleic, phenylacetic, benzoic, salicylic, sulfanilic, fumaric, oxalic, isethionic, and
others known to those of ordinarily skilled in the art. The pharmaceutically acceptable salts
of the present invention can be synthesized from the clindamycin, by conventional methods.
The most preferred salt of clindamycin for the present invention is palmitate hydrochloride
salt
The term 'taste masking' as used in the invention is meant to refer as perceived reduction of
unpleasant taste and/or odour associated with clindamycin in the pharmaceutical composition
and/or after stability.
The term 'pharmaceutical composition' as used in the invention is meant to taste and/or
odour masked discrete particles comprising clindamycin and one or more pharmaceutically
acceptable excipient(s) wherein the composition is solution, suspension, emulsion,
microsuspensions, dispersible tablets for solution/suspension or any other liquid or solid
composition of clindamycin which can be reconstituted to obtain the liquid dosage form.
Preferably the composition of the invention is prepared by dissolving or suspending discrete

particles mixture in the liquid excipient base prior to use for oral administration. Preferably
the liquid excipient base is water.
The phrase 'pharmaceutically acceptable' as used in the invention is meant to refer to those
compounds, materials compositions, or other dosage forms that are, within the scope of
medical judgment, suitable for use in contact with tissues of human beings and animals and
without excessive toxicity, irritation, allergic response, or any other problem or complication.
The term 'discrete particles' includes within its scope but is not limited to compositions
selected from the group comprising powder, granules, microgranules, spheroids, pellets,
micropellets, beads, beadlets, microspheres, nanoparticles, microparticles and microcapsules,
and dispersible tablets. The discrete particles can be coated or uncoated and can be used
preferably in the form of suspension/solution. The discrete particles can be in the form of a
unit dose packet (sometimes referred to in the art as a "sachet") in the form of a
suspension/solution made from a unit dose packet, in the form of a dose-sipping device or
combination thereof e.g. coated pellets filled in a dose sipping device or in a sachet. The use
of the term "suspension " herein is intended to embrace liquids containing clindamycin
partially in suspension and partially in solution or totally in suspension, and the term
'solution' herein is intended to include compositions comprising clindamycin totally
dissolved in the liquid base.
The various techniques can be used for taste masking of clindamycin in the present
composition. Various techniques found to be but not limited to use of flavor enhancers,
applying polymers on the active ingredients by means of technologies like
microencapsulation, complexation with ion exchange resins and inclusion complex formation
with cyclodextrins. Other techniques include solubility-limiting methods, incorporation of
drugs in vesicles and liposome, and chemical modification. However we have surprisingly
found that unpleasant taste and odour of clindamycin can be phenomenally improved by
using polyhydric alcohol(s) while maintaining the stability of the dosage form.

The polyhydric alcohol(s) component of the taste-masked composition according to the
present invention may be selected from one or more of the group comprising propylene
glycol, glycerol, polymers of ethylene glycol, propylene glycol, glycerol such as diethylene
glycol, dipropylene glycol and diglycerol, any polymer of ethylene oxide with a molecular
weight from 200 to 20,000,etc, and block copolymers of ethylene oxide and propylene oxide
commercially known as Poloxamers The poloxamers are commercially available as Pluronic
(BASF) and Teric (ICI).The most preferable polyhydric alcohol used in the invention is
Polyethylene glycol.
Polyethylene glycols are stable, hydrophilic substances. Polyethylene glycols (PEGs) are
widely used in a variety of pharmaceutical formulations including parenteral, topical,
ophthalmic, oral, and rectal preparations. Polyethylene glycol is an addition polymer of
ethylene oxide and water. Polyethylene glycols are chemically stable in air and in solution.
Polyethylene glycols do not support microbial growth, and they do not become rancid.
Suitable polyethylene glycols include PEG or its pharmaceutically acceptable derivatives e.g.
PEG 200; PEG 300; PEG-400; PEG 540; PEG 600; PEG 900; PEG 1000; PEG 1450; PEG
1500; PEG 1540; PEG 2000; PEG 3000; PEG-3350; PEG 4000; PEG 6000; PEG 8000; PEG
20000; Polyethylene oxide, Pegylated-phospholipids and all the possible pharmaceutically
acceptable grades of polyethylene glycol in the art. When used as taste masking agent,
polyethylene glycols of higher molecular weight are used in lower concentrations and
polyethylene glycols of lower molecular weight are used in higher concentrations. Generally,
polyethylene glycol used in the invention is in the range of about 0.5 to about 60 % w/v.
The taste-masked pharmaceutical composition of Clindamycin, or a pharmaceutically
acceptable salt(s) according to present invention further comprises at least one or more other
pharmaceutically acceptable excipient(s) selected from group comprising but not limited to
flavouring agent(s), sweetening agents(s), buffering agents(s), preservative(s), viscosity
enhancing agents(s), antioxidant(s), wetting agent(s), dispersing agent(s), pH stabilizing
agent(s), taste enhancing agent(s), antifoaming agent(s). An excipient can serve multiple
functions, for example as both filler and sweetner.

Flavoring agent(s) are used in the invention is meant to impart a pleasant flavor and /or odor
to a pharmaceutical composition. Suitable flavoring agents include but not limited to natural
and artificial flavors, such as synthetic flavor oils and flavoring aromatics and/or natural oils,
extracts from plants, leaves, flowers, fruits and so forth and combinations thereof.
Representative suitable flavoring agents may be for example, without limitation, menthol,
cinnamon, wintergreen, clove, bay, anise, eucalyptus, thyme, cedar leave, nutmeg, sage,
bitter almonds and cassia, vanilla, artificial vanilla, chocolate, artificial chocolate, bubble
gum, both natural and artificial fruit flavors, such as cherry flavor, grape flavor, orange
flavor, banana flavor, strawberry flavor, lemon flavor, grapefruit flavor and "mint" flavors
such as peppermint flavor and spearmint flavor, lime flavor, apple flavor, pear flavor, peach
flavor, raspberry flavor, plum flavor, pineapple flavor, apricot flavor and so forth, including
combinations of two or more thereof. Flavoring agents are generally provided as a minor
component of the composition in amounts effective to provide a palatable flavor to the
composition. The amount of flavoring agent may depend on a number of factors, including
the desired organoleptic effect. The precise amount of sweetening and/or flavoring agent(s)
depends on the properties of the agent(s) used, however generally in an amount that is
sufficient to mask the unpleasant taste and/or odor associated with clindamycin as
determinable by one skilled in the art. However, flavoring agents generally present is in a
pharmaceutically acceptable range.
Sweeteners suitable for inclusion in the present invention may be determined by one skilled
in the art including, for example without limitation, both natural and artificial sweeteners
such as the representative sweetening agents of intense sweeteners such as sorbitol, sucrose,
saccharins such as sodium saccharin, cyclamates such as sodium cyclamates, aspartame,
sucralose, thaumatin, acesulfam K, and the like, and sugars such as monosaccharides,
disaccharides and polysaccharides. Representative sugars useful in the present invention
include, without limitation, xylose, ribose, glucose, mannose, galactose, fructose, dextrose,
sucrose, maltose, partially hydrolyzed starch or corn syrup, and sugar alcohols such as
sorbitol, xylitol, mannitol, glycerin, etc. and combination thereof. Presently preferred as a
sugar sweetener is sucralose. Sugar sweeteners may be replaced or augmented by water-
soluble artificial sweeteners, such as the suitable artificial sweeteners previously listed and

mixtures thereof. The amount of artificial sweetener used in the composition may vary to
provide an appropriate amount of sweetness as determinable by one skilled in the art.
Mixtures of sweetening and/or flavoring agents are preferably used.
Examples of preservatives suitable for use in the present invention include, for example
without limitation, one or more alkyl hydroxybenzoates, such as methyl hydroxybenzoates,
ethyl hydroxybenzoates, propyl hydroxybenzoates, butyl hydroxybenzoates and the like.
Additional preservatives useful in the present invention include, but are not limited to,
sodium benzoate, potassium sorbate, salts of edetate (also know as salts of
ethylenediaminetetraacetic acid, or EDTA, such as disodium edetate) and antimicrobial
agents including parabens (p-hydroxybenzoic acids esters) such as methyl paraben,
ethylparaben, propylparaben, butylparaben and the like, and combinations thereof. Parabens
are preferred, with methyl paraben most preferred for use as preservative ingredients to add
to the present pharmaceutical composition, although other pharmaceutically acceptable
preservatives may be substituted therefore. Preservative(s) as used in the composition are in a
pharmaceutically acceptable range.
The pharmaceutical composition may also contain a viscosity enhancing agent(s) which
include but are not limited to gums; sorbitol; glycerol; polyvinyl alcohol; polyvinyl
pyrrolidone; polyethylene oxide; cellulose derivatives, such as hydroxypropylmethylcellulose
or a salt thereof, alkyl ether of cellulose, such as methylcellulose, ethylcellulose,
hydroxyethylcellulose, hydroxyethylmethylcellose and mixtures thereof. Preferably the
viscosity-enhancing agent is hydroxypropylmethylcellulose e.g. (HPMC K4M, HPMC K100
LVP; HPMC K15 MP; HPMC E4 MP; HPMC E10 MP CR).
The pharmaceutical composition may also contain a dispersing agent(s), which include but
are not limited to, colloidal silicon dioxide and surfactants, wherein the surfactant is used
alone or as an admixture with one or more surfactant. Combinations of colloidal silicon
dioxide with one or more surfactants can also be used and other pharmaceutically accepted
dispersing agents.

The pharmaceutical composition may also contain a pH - stabilizing agent to maintain a
desired pH. The term "pH - stabilizing agent" encompasses buffers and pH - altering agents.
Suitable pH - stabilizing agents include but not limited to tribasic sodium phosphate,
anhydrous sodium carbonate, glycine, citric acid or mixtures thereof.
Preferably the pH of the composition is in range of about 2.5-about 5.5.
Most preferably the pH of composition is in range from about 2.5- about 3.0
The pharmaceutical composition may also contain wetting agent(s) which include, but are
not limited to such as sorbitan monolaurate, polysorbate 80, and sodium lauryl sulfate and the
like.
The pharmaceutical composition may also contain taste enhancing agents which include, but
are not limited to, sodium chloride, glycine, maltose, dextrose, maltodextrin, citric acid,
tartaric acid and the like and mixtures thereof.
The pharmaceutical composition may also contain suitable coloring agent(s) to provide an
appealing color to the pharmaceutical composition, which include, but are not limited to,
titanium dioxide pigments, lake colors and iron oxide pigments.
The pharmaceutical suspension composition may also contain suitable antifoaming agents,
which include, but are not limited to simethicone emulsion, dimethicone, lutrol and the like.
The pharmaceutical composition may also contain antioxidant(s) which include, but are not
limited to such as tocopherols, gallic acid and gallates, butylated hydroxy anisole, butylated
hydroxy toluene, ascorbic acid, maleic acid, sodium bisulphate, sodium metabisulphite,
sodiumformaldehyde sulphoxylate and the like.

The pharmaceutical composition may also contain suitable lubricants and flow aids such as,
but not limited to, talc, magnesium stearate, calcium silicate, 1- leucine and colloidal silicon
dioxide.
All these excipients can be used at levels well known to the persons skilled in the art.
The specifically mentioned pharmaceutically acceptable excipient(s) are intended to be
exemplary, not exhaustive, of specific excipients that may be used in the practice of the
disclosed invention. It is further understood that more than one of any particular type of
excipient may be used in the compositions described herein. For example, the compositions
may include more than one flavorant, colorant, etc. Also, a single excipient may provide
multiple functions.
Further the compositions of the present invention comprises more than about 8% of active
(free base) by weight of total solid content of the composition. The present invention
comprises preferably more than about 10% of active (free base) by weight of total solid
content of the composition.
It has been found that the clindamycin composition of present invention has less solid content
compared to the innovator. The marketed clindamycin formulation (Cleocin Padeatric®) has
about 40gm of solid content to be reconstituted before use compared to the invention which
has about 13gm of solid content, thereby reducing the solid content to about thrice
comparative to the innovator with improved taste, odor and more stablility compared to the
innovator. Thus by using present invention the solid content of the composition has
substantially reduced compared to the innovator with improvement in the organoleptic
properties.
An clindamycin discrete particles for in accordance with the present invention may be
supplied in bottles which upon reconstitution, for example, aqueous media will preferable
contain 75mgof clindamycin/5ml.The discrete particles can also be supplied in unit dosage of

packets or sachets that, upon reconstitution in aqueous media, provide a unit dose of
clindamycin.
The composition(s) of the present invention can be prepared by means well known to those
skilled in the art such as but not limited to dry mixing, dry granulation, direct compression,
wet granulation (which can be aqueous or non aqueous solvent(s)).
The solvent(s) used in aqueous or non-aqueous granulation in the present invention include
all the solvents well known in the art.
For example, the discrete particles for the present invention can be prepared by a process
comprising the steps of a) dry mixing clindamycin, polyhydric alcohol and other
pharmaceutically acceptable excipient(s) to get a dry mixture; b) granulating the dry mixture
above with a granulating liquid prepared by mixing the suitable pharmaceutically acceptable
excipient(s) with aqueous /non-aqueous fluid to obtain a wet mass; c) drying the wet mass to
obtain the discrete particles; d) lubricating the discrete particles obtained with a suitable
lubricating agent and/or flavour(s).
The discrete particles of the present invention can also be prepared by a process comprising
the steps of a) melting polyhydric alcohol and mixing with clindamycin and one or more
other pharmaceutically acceptable excipient(s) properly to obtain a uniform mass; b) further
processing the obtained uniform mass to obtain discrete particles; c) lubricating the discrete
particles obtained with a suitable lubricating agent and/or flavour(s).
Where applicable, the discrete particles for the invention can be reconstituted using potable
water or using juices such as apple juice, strawberry juice, orange juice or using aerated or
carbonated preparations. Alternatively, for the suspension per se, vehicles well known to
persons skilled in the art, such as propylene glycol, glycerin, sucrose solution, sorbitol, liquid
glucose and the like can also be used, at levels well known to the persons skilled in the art, in
addition to water

The following examples are illustrative of the present invention, and the examples should not
be considered as limiting the scope of this invention in any way, as these examples and other
equivalents thereof will become apparent to those versed in the art, in the light of the present
disclosure, and the accompanying claims.

Procedure:
Step1:
Melt PEG (Temperature NMT 60°C); add preservative to melted PEG, mix thoroughly to
ensure complete mixing. Pass Clindamycin, Dextrin, Artificial sweetener, Sucrose and
suitable wetting agent through suitable mesh and mix them geometrically. Add this mixture
to melted PEG and stir continuously to ensure complete mixing to get a uniform mass. Cool
the blend to room temperature with constant stirring. Pass the solidified blend through
suitable sieve and collect the granules.
Step2:
Lubricate the granules of Stepl using suitable flavors and reconstitute it before
administration.


Procedure:
Step1:
Melt PEG (Temperature NMT 60°C); add preservative to melted PEG, mix thoroughly to
ensure complete mixing. Pass Clindamycin, Dextrin, Mannitol, Artificial sweetener and
suitable wetting agent through suitable mesh and mix them geometrically. Add this mixture
to melted PEG and stir continuously to ensure complete mixing to get a uniform mass. Cool
the blend to room temperature with constant stirring. Pass the solidified blend through
suitable sieve and collect the granules.
Step2:
Lubricate the granules of Stepl using suitable flavors and reconstitute it before
administration.

Procedure:
Step1:

Melt PEG (Temperature NMT 60°C); add preservative to melted PEG followed by addition
of Clindamycin, stir continuously to ensure complete mixing to get a uniform mass. Cool the
blend to room temperature with constant stirring. Pass the solidified blend through suitable
sieve and collect the granules.
Step2: Pass, Dextrin, Sucrose, Lactose, Artificial sweetener and suitable wetting agent
through suitable mesh and mix them geometrically.
Step3: Mix the blend of step 2 with granules of step1.
Step4: Lubricate the mix of Step3 using suitable flavors and reconstitute it before
administration.

Procedure:
Step1:
Procedure-Pass Clindamycin, PEG, Dextrin, Wetting agent, artificial sweetener, Preservative
and Sucrose through suitable mesh and mix them geometrically. Granulate this mixture using
Sucrose solution. Dry the mass for 15-20 min at 40°C. Pass the dried mass through suitable
sieve and collect the granules.
Step2: Lubricate the granules of Stepl using suitable flavors and reconstitute it before
administration.


Procedure:
Step1: Pass Clindamycin, PEG, Dextrin, Wetting agent, Artificial sweetener, Preservative
and Sucrose through suitable mesh and mix them geometrically. Granulate this mixture using
isopropyl alcohol as a granulating aid. Dry the mass for 15-20 min at 40°C. Pass the dried
mass through suitable sieve and collect the granules
Step2: Lubricate the granules of Stepl using suitable flavors and reconstitute it before
administration.

Procedure:
Stepl: Pass Clindamycin, PEG, Dextrin, Wetting agent, Artificial sweetener, Preservative
and Sucrose through suitable mesh and mix them geometrically. Granulate this mixture using

Poly vinyl Pyrrolidone and isopropyl alcohol solution as a granulating aid. Dry the mass for
15-20 min at 40°C and collect the final granules from suitable sieve.
Step2: Lubricate the granules of Step1 using suitable flavors and reconstitute it before
administration.

Procedure:
Stepl: Pass Clindamycin, PEG, Dextrin, Wetting agent, Artificial sweetener, Lactose and
Preservative through suitable mesh and mix them geometrically. Granulate this mixture using
Hypromellose and water solution as a granulating aid. Dry the mass for 15-20 min at 40°C.
Pass the dried mass through suitable sieve and collect the granules
Step2: Lubricate the granules of Stepl using suitable flavors and reconstitute it before
administration



Procedure: Step 1 and Step 2 were performed using Fluid Bed coater. All the ingredients of
step 3 were passed through suitable sieve and mixed thoroughly with the Eudragit coated
drug loaded pellets. Dry suspension powder thus formed was then filled in final containers,
which is reconstituted before administration.

Procedure -Pass Clindamycin, PEG, Dextrin, Wetting agent, Artificial sweetener,
Preservative, Sucrose and flavors through suitable mesh and mix them geometrically to
assure complete mixing. Dry powder thus formed was then filled in final containers, which is
reconstituted before administration.

Evaluation of Taste Masking Effect: Sensory Test
20 healthy volunteers involved in the study were exposed to the taste of the reconstituted
Innovator's Formulation (Cleocin pediatric®) and Example 1, 4 and 5 of present invention
on day 1, day 7 and day 14. The liquid compositions were subjected to sensory test. Each of
the liquid composition was actually put in the mouth of twenty volunteers, in an amount
equivalent to 75mg of the liquid clindamycin palmitate hydrochloride. The results indicated
that Example 1 and 5 has better acceptance than the marketed Cleocin pediatric®.
Evaluation of Odor Test
20 healthy volunteers involved in the study were exposed to the smell of the reconstituted
Innovator's Formulation (Cleocin pediatric®) and Example 1, 4 and 5 of present invention
on day1, day 7 and day 14. Their like/dislike for the odor of the compositions was ranked as
preferred/ not preferred followed by the qualitative interpretation of their response. The
recorded responses are as mentioned below in Table No. 1:

Stability Data:
Accelerated Stability Studies as per ICH guidelines, have been performed for the
compositions at room temperature (RT), at 40 °C and at 60 °C. As per the observations made
the composition of the present invention are more stable than Innovator's Formulation
(Cleocin pediatric®) under the conditions mentioned.

WE CLAIM:
1. A taste masked pharmaceutical composition of clindamycin, or a pharmaceutically
acceptable salt(s), hydrate(s), solvate(s) and physiologically functional derivative(s)
and precursors thereof, which includes all polymorphic forms, whether crystalline or
amorphous comprising polyhydric alcohol(s); and one or more other
pharmaceutically acceptable excipient(s).
2. The taste masked pharmaceutical composition of claim 1, wherein the polyhydric
alcohol is present from about 0.5 % to about 60% w/v of the total composition.
3. The taste masked pharmaceutical composition of claim 1, wherein polyhydric alcohol
is selected from the group comprising glycerol, propylene glycol, polymers of
ethylene glycol, any polymers of ethylene oxide with a molecular weight from 200 to
20,000 and block copolymers of ethylene oxide and propylene oxide.
4. The taste masked pharmaceutical composition of claim 3 wherein the polyhydric
alcohol is polyethylene glycol.
5. The taste masked pharmaceutical composition of claim 1, wherein one or more
pharmaceutically acceptable excipient(s) comprises one or more flavouring agent(s),
sweetening agents(s), buffering agents(s), preservative(s), viscosity enhancing
agents(s), antioxidant(s), wetting agent(s), dispersing agent(s), pH stabilizing
agent(s), taste enhancing agent(s), antifoaming agent(s) or mixtures thereof.
6. A taste masked pharmaceutical composition of claim 1 wherein the composition is a
ready -to-use discrete particles.

7. A taste masked pharmaceutical composition of claim 6 wherein the discrete particles
comprises powder, granules, microgranules, spheroids, pellets, micropellets, beads,
beadlets, microspheres, dispersible tablets, nanoparticles, microparticles and
microcapsules.
8. A taste masked pharmaceutical composition of clindamycin, wherein the amount of
active in free base form is more than about 8% by weight of total solid content of the
composition.
9. A taste masked pharmaceutical composition of claim 8 wherein the amount of active
in free base form is more than about 10% by weight of total solid content of the
composition.
10. A taste masked pharmaceutical composition of clindamycin according to claim 9
wherein the weight of the total solid content of the pharmaceutical composition is
reduced compared to the marketed formulation.
11. A taste masked pharmaceutical composition of claim 1 wherein the organoleptic
properties of clindamycin and stability of present invention is improved as compared
to the marketed formulation.
12. A process for preparation of a taste masked pharmaceutical composition of
clindamycin or a pharmaceutically acceptable salt(s) thereof the said process
comprising the steps of a) dry mixing clindamycin, polyhydric alcohol and other
pharmaceutically acceptable excipient(s) to get a dry mixture; b) granulating the dry
mixture above with a granulating liquid prepared by mixing the suitable
pharmaceutically acceptable excipient(s) with aqueous /non-aqueous fluid to obtain a
wet mass; c) drying the wet mass to obtain the discrete particles; d) lubricating the
discrete particles obtained with a suitable lubricating agent and/or flavour(s).

13. A process for preparation of a taste masked pharmaceutical composition of
clindamycin or a pharmaceutically acceptable salt(s) thereof the said process
comprising the steps of a) melting polyhydric alcohol and mixing with clindamycin
and one or more other pharmaceutically acceptable excipient(s) properly to obtain a
uniform mass; b) further processing the obtained uniform mass to obtain discrete
particles; c) lubricating the discrete particles obtained with a suitable lubricating
agent and/or flavour(s).

A taste masked pharmaceutical composition of clindamycin, or a pharmaceutically
acceptable salt(s), hydrate(s), solvate(s) and physiologically functional derivative(s) and
precursors thereof, which includes all polymorphic forms, whether crystalline or amorphous
comprising polyhydric alcohol(s); and one or more other pharmaceutically acceptable
excipient(s). A process for preparation of a taste masked pharmaceutical composition of
clindamycin or a pharmaceutically acceptable salt(s) thereof the said process comprising the
steps of a) dry mixing clindamycin, polyhydric alcohol and other pharmaceutically
acceptable excipient(s) to get a dry mixture; b) granulating the dry mixture above with a
granulating liquid prepared by mixing the suitable pharmaceutically acceptable excipient(s)
with aqueous /non-aqueous fluid to obtain a wet mass; c) drying the wet mass to obtain the
discrete particles; d) lubricating the discrete particles obtained with a suitable lubricating
agent and/or flavour(s).