FORM 2
THE PATENTS ACT 1970
(39 of 1970)
AND
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION.
"NOVEL PHARMACEUTICAL COMPODITION"
2. APPLICANT:
(a) NAME: CIPLA LTD.
(b)NATIONALITY: Indian Company incorporated under the Companies Act, 1956
(c) ADDRESS: 289, Bellasis Road, Mumbai Central, Mumbai - 400 008, Maharashtra, India.
3.PREAMBLE TO THE DESCRIPTION:
The following specification particularly describes the invention and the
manner in which it is to be formed.

RELATED APPLICATION:
This application is Complete Cognate Application for the Provisional Patent Application No. 1782/MUM/2010 dated 11/06/2010; and Provisional Patent Application No. 2399/MUM/2010 dated 27/08/2010.
FIELD OF INVENTION:
The present invention relates to a novel pharmaceutical composition comprising of antiretroviral drugs suitable for administration in children. The present invention also relates to a process of preparing the said novel pharmaceutical composition.
BACKGROUND AND PRIOR ART:
Acquired Immune Deficiency Syndrome (AIDS) causes a gradual breakdown of the body's immune system as well as progressive deterioration of the central and peripheral nervous systems. Two distinct retroviruses, human immunodeficiency virus (HIV) type-1 (HIV-1) or type- 2 (HIV-2), have been etiologically linked to the immunosuppressive disease, acquired immunodeficiency syndrome (AIDS). HIV seropositive individuals are initially asymptomatic but typically develop AIDS related complex (ARC) followed by AIDS. Affected individuals exhibit severe immunosuppression, which predisposes them to debilitating and ultimately fatal opportunistic infections. Retroviral replication routinely features post-translational processing of polyproteins. This processing is accomplished by virally encoded HIV protease enzyme. This yields mature polypeptides that will subsequently aid in the formation and function of infectious virus. If this molecular processing is stifled, then the normal production of HIV is terminated. Therefore, inhibitors of HIV protease may function as anti-HIV viral agents.
The oral route is the most popular and convenient route for drug administration. Currently almost all forms of oral anti retroviral medications that are available for pediatric population are in the dosage forms as tablet and capsule. As the dose of antiretroviral medications are comparatively high which results into dosage forms of inappropriate size rendering it difficult for pediatric patients to administer such dosage forms. Pediatric

patients usually are unable to swallow such bulky dosage forms as pills, capsules or tablets and many of these pediatric patients have to be administered as crushed tablets or dispense the capsule contents in a suitable vehicle. Such inappropriate formulations lead to bad taste and poor acceptability in pediatric patients which in turn can lead to treatment failure.
Currently various formulations are available comprising antiretroviral drugs such as COMBIVIR, EMTRIVA, EPIVIR, HIVID, RETROVIR, TRIZIVIR, VIDEX, VIDEX EC, VIREAD, ZERIT, ZIAGEN, AGENERASE, CRIXIVAN, FORTOVASE, INVIRASE, KALETRA, NORV1R, REYATAZ and VIRACEPT. However these are available in conventional dosage forms and hence such formulations may be unacceptable to pediatric patients.
WO02096395 relates to soft elastic capsules and HIV protease inhibiting compounds contained in the soft elastic capsule. However, pediatric patients may experience difficulty in swallowing larger sized capsules wherein large size results in esophageal damage due to physical characteristics of the dosage form if it is not swallowed properly, which leads to poor patient compliance. Apart from above, palatability and medicament acceptance are also one of the most important parameters governing patient compliance. Oral administration of bitter drugs with an acceptable degree of palatability is a key issue for health care providers, especially for pediatric patients.
WO9822106 discloses liquid pharmaceutical composition of compounds which are inhibitors of HIV protease with improved oral bioavailability. WO9822106 in particular, discloses a composition in the form of a solution having an HIV protease inhibitor, an organic solvent and a surfactant. It further discloses that the composition can be encapsulated in either hard gelatin capsules or soft elastic capsules (SEC). However, this composition involves a complex manufacturing process and also renders a formulation which may be unacceptable for the pediatric patients.
US4792449 discloses chocolate as a vehicle for delivery of lipid soluble medications which involves solubilization of the medicament in chocolate admixed with oil. However this patent discloses chocolate as a vehicle only for delivering lipid soluble medicaments.

Various methods have been suggested in prior art which mention that the use of inappropriate formulation and bad taste can be avoided by administering the drug with chocolate milk, chocolate or vanilla pudding, or ice cream to improve the taste. The taste can also be improved by swallowing a spoonful of peanut butter before taking it. Other available suggestions for minimizing the bad taste includes administration with molasses, honey, table syrup, maple syrup, chocolate syrup, mint ice cream, or coffee, or eating chips after your dose.
In spite of all the available antiretroviral formulations and various methods suggested for preparing such antiretroviral formulations there have been difficulties such as incorporating antiretroviral drugs in the chocolate base, blending the mixture of the drug and the chocolate base uniformly and thereby dispersing the drug evenly in the chocolate base and providing a formulation which is stable and suitable for administration to pediatric patients.
Hence, there still remains a need to formulate a suitable pharmaceutical composition which is acceptable, has enhanced palatability which uniformly blends and disperses lipophilic and/or hydrophilic antiretroviral drugs and yet is prepared by a simple manufacturing process.
OBJECT OF THE INVENTION:
The object of the present invention is to provide a novel pharmaceutical composition comprising antiretroviral drugs suitable for administration to pediatric patients.
Another object of the present invention is to provide a novel pharmaceutical composition comprising antiretroviral drugs optionally with pharmaceutically acceptable excipients suitable for administration to pediatric patients.
Yet another object of the present invention is to provide a process for preparing the novel pharmaceutical composition comprising antiretroviral drugs..

One more object of the present invention is to provide a novel pharmaceutical composition for use in treating disorders or conditions that respond to, or are prevented, ameliorated or eliminated by, the administration of antiretroviral drugs.
SUMMARY OF THE INVENTION:
According to a one aspect of the present invention, there is provided a novel pharmaceutical composition comprising atleast one antiretroviral drug, or their pharmaceutically acceptable salts, solvates, hydrates, enantiomers, derivatives, polymorphs or prodrugs and a chocolate base.
According to a another aspect of the present invention, there is provided a novel pharmaceutical composition comprising atleast one antiretroviral drug, or their pharmaceutically acceptable salts, solvates, hydrates, enantiomers, derivatives, polymorphs or prodrugs uniformly blended and dispersed in a chocolate base.
According to a yet another aspect of the present invention, there is provided a novel pharmaceutical composition comprising atleast one antiretroviral drug, or their pharmaceutically acceptable salts, solvates, hydrates, enantiomers, derivatives, polymorphs or prodrugs in a chocolate base optionally with one or more pharmaceutically acceptable excipients.
According to a still another aspect of the present invention, there is provided a process for preparing a novel pharmaceutical composition comprising atleast one antiretroviral drug, or their pharmaceutically acceptable salts, solvates or hydrates, enantiomers, derivatives, polymorphs or prodrugs, the process comprising blending and dispersing one or more antiretroviral drugs in the chocolate base.
According to a further aspect of the present invention, there is provided a novel pharmaceutical composition comprising atleast one antiretroviral drug, or their pharmaceutically acceptable salts, solvates, hydrates, enantiomers, derivatives, polymorphs or prodrugs and a chocolate base for use in treating disorders or conditions

that respond to, or are prevented, ameliorated or eliminated by, the administration of antiretroviral drugs.
DETAILED DESCRIPTION OF THE INVENTION:
It is possible to uniformly disperse antiretroviral drugs in chocolate base at controlled temperature which results in a novel pharmaceutical composition which is suitable for administration in pediatric patients and moreover is prepared by a simple manufacturing process.
The term "pharmaceutically acceptable" mentioned throughout the specification would be applied to a carrier, diluent or excipient which is compatible with atleast one antiretroviral drugs as employed.
The novel pharmaceutical composition, according to the present invention may comprise atleast one antiretroviral drug which may be hydrophilic or lipophilic, or their pharmaceutically acceptable salts, solvates, hydrates, enantiomers, derivatives, polymorphs or prodrugs uniformly blended and dispersed in a chocolate base.
Antiretroviral agents for the purpose of the present invention may be selected from nucleoside and nucleotide reverse Transcription inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase inhibitors and maturation inhibitors.
According to the present invention, the class of antiretroviral drugs may comprise, one or more, protease inhibitors such as lopinavir, ritonavir, saquinavir, amprenavir, atazanavir, tipranavir, fosamprenavir, indinavir, nelflnavir, darunavir,lasinavir; palinavir; fosamprenavir; nucleoside reverse transcriptase inhibitors such as lamividine, stavudine, zidovudine, didanosine, zalctabine, emtricitabine, abacavir, entecavir, apricitabine, adefovir; lobucavir; apricitabine; dexelvucitabine; alovudine; amdoxovir; elvucitabine; racivir; stampidine, festinavir; nucleotide reverse transcriptase inhibitors such as tenofovir; adefovir; non-nucleoside reverse transcriptase inhibitors like efavirenz,

nevirapine, delavirdine, etravirine, rilpiverine, delaviridine; integrase inhibitors such as raltegravir, elvitegravir; and combinations thereof.
The novel pharmaceutical composition, of the present invention may be a single layered or multilayered wherein atleast one lipophilic antiretroviral drug and/or atleast one hydrophilic antiretroviral drug may be provided in a single layer of chocolate base or in a multilayered chocolate base.
According to one embodiment, the novel pharmaceutical composition of the present invention may comprise atleast one nucleotide reverse transcriptase inhibitors such as tenofovir in a single layer of chocolate base or in a multilayered chocolate base.
According to another embodiment, the novel pharmaceutical composition of the present invention, may comprise atleast one nucleotide reverse transcriptase inhibitors such as tenofovir in one single layer of the multilayered chocolate base or may be incorporated in different layers of the multilayered chocolate base.
According to yet another embodiment, the novel pharmaceutical composition of the present invention may comprise atleast one nucleoside reverse transcriptase inhibitors such as abacavir and atleast one nucleotide reverse transcriptase inhibitors such as tenofovir in a single layer chocolate base or in a multilayer chocolate base.
According to a further embodiment, the novel pharmaceutical composition of the present invention, may comprise atleast one nucleoside reverse transcriptase inhibitors such as abacavir and atleast one nucleotide reverse transcriptase inhibitors such as tenofovir in multilayered chocolate base wherein atleast one nucleoside reverse transcriptase inhibitors such as abacavir and atleast one nucleotide reverse transcriptase inhibitors such as tenofovir may be incorporated in one single layer of the multilayered chocolate base or may be incorporated in different layers of the multilayered chocolate base
According to a still further embodiment, the novel pharmaceutical composition of the present invention atleast one antiretroviral drug may be incorporated in a single layer of chocolate base for example tenofovir may be incorporated in a single layer of chocolate

base, abacavir, lamivudine, zidovudine may be incorporated in a single layer of chocolate base.
The novel pharmaceutical composition, of the present invention may comprise atleast one lipophilic antiretroviral drug and/or atleast one hydrophilic antiretroviral drug incorporated in one or more coatings that surround a core or may comprise atleast one lipophilic antiretroviral drug and/or atleast one Hydrophilic antiretroviral drug is uniformly dispersed in the core surrounded by one or more coatings.
According to one aspect of the present invention, the core may comprise sugars, polyols, shellac, zein, lipids, and gelling agents, gelatins, pectin, hydrocolloids, cellulose gums, modified starches, crosslinked starches and combinations thereof.
According to another aspect of the present invention, the coating may comprise sugars, polyols, shellac, zein, lipids, and gelling agents, gelatins, pectin, hydrocolloids, cellulose gums, modified starches, crosslinked starches and combinations thereof.
According to one embodiment, the pharmaceutical composition of the present invention may comprise atleast one nucleotide reverse transcriptase inhibitors such as tenofovir in one or more coatings that surround a core.
According to another embodiment, the pharmaceutical composition of the present invention may comprise atleast one nucleotide reverse transcriptase inhibitors such as tenofovir in the core surrounded by one or more coatings.
According to one more embodiment, the pharmaceutical composition of the present invention may comprise atleast one nucleoside reverse transcriptase inhibitors such as abacavir and atleast one nucleotide reverse transcriptase inhibitors such as tenofovir in one or more coatings that surround a core.
According to yet another embodiment, the pharmaceutical composition of the present invention may comprise atleast one nucleoside reverse transcriptase inhibitors such as

abacavir and atleast one nucleotide reverse transcriptase inhibitors such as tenofovir in the core surrounded by one or more coatings.
According to the present invention, the novel pharmaceutical composition may comprise atleast one lipophilic antiretroviral drug and/or atleast one hydrophilic anti retroviral drug in a granulated form, particulate form or its mixture which may be micronized, nanosized or its mixture and such other forms which may be known to the person having a skill in the art.
According to the present invention, the novel pharmaceutical composition may comprise a chocolate base that may be selected from the group such as but not limited to plain chocolate, milk chocolate, black chocolate and chocolate cream or special chocolate with coconut or almonds or combinations thereof.
Typically, a conventional chocolate base may have various contents such as cocoa butter, cocoa bean, cocoa butter equivalents, cocoa butter substitutes, cocoa butter replacers, cocoa butter fractions, cocoa butter improvers, other lipids, sugar as sucrose, fructose, glucose and dextrose or artificial sugars, whole milk powder or milk crumb, chocolate liquor, lecithin, vanillin and such other contents which may be known to the person having a skill in the art.
The chocolate base is a stable edible product, which can be used as intermediary preblended ingredient suitable for preparing chocolate or other food products.
The novel pharmaceutical composition, of the present invention, may comprise chocolate base which may be manufactured by a conventional technique which generally include blending of cocoa ingredients, and optionally milk fat, with dry ingredients, optionally refining the resulting mass with one or more confectionery refiners to produce a smooth gritless texture; a conching process, which is an extended duration batch process of intense mixing, agitating and aerating at a specific temperature/time profile, and where other ingredients are typically added to create the chocolate mass; and then tempering, forming, and cooling the chocolate mass.

There is further provided a process for preparing the novel pharmaceutical composition of the present invention.
The novel pharmaceutical composition of the present invention may be prepared by melting the chocolate base, dispersing atleast one antiretroviral drug in the melted chocolate base and freezing the chocolate base comprising atleast one antiretroviral drug.
According to the present invention, there is provided a process of manufacturing the novel pharmaceutical composition, which process comprises:
(1) Melting the chocolate base at a controlled temperature
(2) Conching the molten chocolate base at a controlled temperature
(3) Adding the drug to the molten chocolate base obtained in step (2)
(4) Filling the moulds with the chocolate mass obtained in step (3)
(5) Freezing the moulds at a controlled temperature to obtain the chocolate bar.
(6) Curing the chocolate bar obtained in step (5) at a controlled temperature
There is further provided by the present invention a novel pharmaceutical composition substantially as hereinbefore described, for use in treating disorders or conditions that respond to, or are prevented, ameliorated or eliminated by, the administration of antiretroviral drugs. More preferably, there is further provided by the present invention a novel pharmaceutical composition substantially as hereinbefore described, for use in the treatment of Human immunodeficiency virus [HIV].
The following examples are for the purpose of illustration of the invention only and are not intended in any way to limit the scope of the present invention.
Example 1:

Sr. No. Ingredients Qty/Unit
(g)
1. Abacavir sulphate 0.1757
2. Lamivudine USP 0.075

3. Zidovudine USP 0.150
4. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.6g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Abacavir sulfate, lamivudine and zidovudine were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours
Example 2:

Sr. No. Ingredients Qty / Unit
(g)
1. Tenofovir disoproxil fumarate 0.300
2. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.7g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Tenofovir disoproxil fumarate was added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.

(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours Example 3:

Sr. No. Ingredients Qty/Unit
(g)
1. Abacavir sulphate 0.3514
2. Milk chocolate base 1NH q.s. to 2.0 g (Approx. 1.65 g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Abacavir sulfate was added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours
Example 4:

Sr. No. Ingredients Qty / Unit
(g)
1. Abacavir sulphate 0.3514
2. Lamivudine USP 0.150
3. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.50 g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C

(3) Abacavir sulfate and Lamivudine were added to the molten milk chocolate base
obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours
Example 5:

Sr. No. Ingredients Qty / Unit
(g)
1. Lamivudine USP 0.150
2. Zidovudine USP 0.300
3. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.55 g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Lamivudine and Zidovudine were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours
Example 6:

Sr. No. Ingredients Qty /Unit
(g)
1. Lamivudine USP 0.030
2. Zidovudine USP 0.060

3. Nevirapine USP 0.040
4. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.87 g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Lamivudine, Zidovudine and Nevirpine were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours
Example 7:

Sr. No. Ingredients Qty/Unit
(g)
I. Lamivudine USP 0.060
2. Zidovudine USP 0.120
3. Nevirapine USP 0.120
4. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.70 g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Lamivudine, Zidovudine and Nevirpine were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.

(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours Example 8:

Sr. No. Ingredients Qty / Unit
(g)
1. Lamivudine USP 0.040
2. Zidovudine USP 0.090
3. Nevirapine USP 0.050
4. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.82 g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Lamivudine, Zidovudine and Nevirpine were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours
Example 9:

Sr. No. Ingredients Qty/Unit
(g)
1. Stavudine 0.030
2. Lamivudine 0.15
3. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.82 g)
Total 2.0 g

Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Stavudine and Lamivudine were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours
Example 10:

Sr.No. Ingredients Qty/Unit
(g)
1. Stavudine 0.030
2. Lamivudine 0.15
3. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.82 g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Stavudine and Lamivudine were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours

Example 11:

Sr. No. Ingredients Qty / Unit
(g)
I. Lamivudine USP 0.300
2. Tenofovir disoproxil fumerate 0.300
3. Milk chocolate base 1NH q.s. to 2.0 g (Approx. 1.4g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C
(3) Lamivudine and Tenofovir were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20CC for 12 hours
Example 12:

Sr. No. Ingredients Qty/Unit
(g)
1. Nevirapine 0.050
2. Lamivudine 0.030
3. Stavudine 0.006
4. Milk chocolate base INH q.s. to 2.0 g (Approx. 1.914 g)
Total 2.0 g
Process:
(1) Milk chocolate base was melted at a temperature between 45-50°C
(2) Molten milk chocolate base was conched at a temperature between 45-50°C

(3) Nevirapine, Lamivudine and Stavudine were added to the molten milk chocolate base obtained in step (2)
(4) The moulds were filled with the chocolate mass obtained in step (3)
(5) The moulds were freezed at a temperature between 10-15° for 25-30 minutes to obtain the chocolate bar.
(6) The chocolate bar obtained in step (5) was cured at a temperature of 20°C for 12 hours.
It will be readily apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the spirit of the invention. Thus, it should be understood that although the present invention has been specifically disclosed by the preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered to be falling within the scope of the invention.
It is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
It must be noted that, as used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to "an excipient" includes a single excipient as well as two or more different excipients, and the like.

We Claim,
1) A pharmaceutical composition comprising atleast one antiretroviral drug, atleast one chocolate base.
2) A pharmaceutical composition as claimed in claim 1, wherein the antiretroviral drug is hydrophilic and/or lipophilic.
3) A pharmaceutical composition as claimed in claim 1, wherein the antiretroviral drug comprises lopinavir, ritonavir, saquinavir, amprenavir, atazanavir, tipranavir, fosamprenavir, indinavir, nelfinavir, darunavir, lasinavir; palinavir; fosamprenavir; lamividine, stavudine, zidovudine, didanosine, zalctabine, emtricitabine, abacavir, entecavir, apricitabine, adefovir; lobucavir; apricitabine; dexelvucitabine; alovudine; amdoxovir, elvucitabine; racivir; stampidine, festinavir, tenofovir; adefovir, efavirenz, nevirapine, delavirdine, etravirine, rilpiverine, delaviridine, raltegravir, elvitegravir or its pharmaceutically acceptable salts, solvates, hydrates, enantiomers, derivatives, polymorphs or prodrugs or combinations thereof.
4) A pharmaceutical composition as claimed in any of the preceding claims, wherein atleast one antiretroviral drug is uniformly dispersed in the chocolate base.
5) A pharmaceutical composition as claimed in any of the preceding claims, wherein the composition is single layered or multilayered.
6) A pharmaceutical composition as claimed in any of the preceding claims, wherein the chocolate base comprises plain chocolate, milk chocolate, black chocolate and chocolate cream or special chocolate with coconut or almonds or combinations thereof.
7) A process for preparing the pharmaceutical composition which process comprises melting the chocolate base, dispersing atleast one antiretroviral drug in the melted chocolate base and freezing the chocolate base comprising atleast one antiretroviral drug.

8) A process for preparing the pharmaceutical composition as claimed in claim 7,
wherein the process comprises
a) Melting the chocolate base at a controlled temperature;
b) Conching the molten chocolate base at a controlled temperature;
c) Adding atleast one antiretroviral drug to the molten chocolate base obtained in step (b);
d) Filling the moulds with the chocolate mass obtained in step (c);
e) Freezing the moulds at a controlled temperature to obtain the chocolate bar;
f) Curing the chocolate bar obtained in step (e) at a controlled temperature.

9) A pharmaceutical composition comprising atleast one antiretroviral drug, wherein atleast one antiretroviral drug is uniformly dispersed either in the core or in the coating.
10) A pharmaceutical composition as claimed in claim 9, wherein the core and or the coat comprises sugars, polyols, shellac, zein, lipids, gelling agents, gelatins, pectin, hydrocolloids, cellulose gums, modified starches, crosslinked starches and combinations thereof.
11) A pharmaceutical composition as claimed in any of the preceding claims, wherein the antiretroviral drug is in granulated form, particulate form, micronized, nanosized or mixtures thereof.
12) A pharmaceutical composition substantially herein described with reference to the accompanying examples.