WO2005089719A1 - Polish compositions - Google Patents
Polish compositions Download PDFInfo
- Publication number
- WO2005089719A1 WO2005089719A1 PCT/IB2004/000405 IB2004000405W WO2005089719A1 WO 2005089719 A1 WO2005089719 A1 WO 2005089719A1 IB 2004000405 W IB2004000405 W IB 2004000405W WO 2005089719 A1 WO2005089719 A1 WO 2005089719A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- weight
- composition
- polish
- polish composition
- polyethylene glycol
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
Definitions
- This invention is in the field of polish compositions for edible substrates comprising of polyethylene glycol and /or its analogs, a plasticizer, a film former, a film detackifier and a glidant.
- the composition can be used as a dry powder, or as an aqueous or non-aqueous suspension. Coating of substrates with the above composition imparts a glossy and shining appearance to the coated substrates and thus reduces the frictional effects between individual substrate particles after coating. This results in lesser chipping or fragmentation of the substrate during packaging, which is performed after coating and thus retains the integrity of the coated substrate by minimizing the frictional effects during subsequent operations.
- wax polish compositions are solutions of wax in an organic solvent such as carbon tetrachloride or ether.
- organic solvent such as carbon tetrachloride or ether.
- these solvents give rise to processing problems because of their toxic, inflammable and non-environmental friendly nature.
- inadvertent over use of wax based solutions may spoil the substrate by adhesion of excess wax to the surface.
- Conventional wax polishing using an aqueous based system may result in spoiling the surface of the substrate due to over-washing.
- U . S.Pat Nos.3438794, 5023108, 5389129, 5733575, 6013282, 6039976 and WO0109259 all discuss wax based polish compositions with their advantages.
- the present invention provides a polish composition that is not wax based and has the following advantages.
- the composition can be used as a powder and as a reconstituted suspension.
- the reconstitution can be in an aqueous or non-aqueous solvent or mixtures thereof.
- composition of the present invention comprises of a polyethylene glycol, plasticizer, film former, detackifier and a glidant.
- the polish composition of the present invention may contain a suitable preservative active in the range of pH 3.0 to 7.0 and acceptable for food/pharmaceutical use.
- composition of our present invention is:
- HPMC Hydroxypropylmethylcellulose
- the substrates are to be rotated in the coating pan after spraying is complete for atleast 15 minutes till they are completely dried.
- the solid content of the solution and the weight gain during coating may be varied depending on the substrate and the desired final product.
- the preferred composition may be reconstituted in a non-aqueous medium as follows: Prepare an non-aqueous suspension of the above composition at a concentration of 0.2% of the total weight of the tablets to be coated and prepare a 5% solution in a mixture of Isopropyl alcohol and dichloromethane by dispersing the dry polish composition in isopropyl alcohol under stirring and adding dichloromethane during stirring for a period of at least 10 minutes till a uniform suspension is formed. Coat the substrate by the process of spraying the polishing suspension onto the substrates under the following coating parameters:
- the substrates are to be rotated in the coating pan after spraying is complete for atleast 15 minutes till they are completely dried.
- the preferred composition may be reconstituted in a hydro-alcoholic medium as follows:
- % friability gives an indication of the physical pressures that a tablet can withstand during further processising and there is a limit of 1 % so that product specifications are adhered to and the patient gets a quality product.
- Examples 6-8 reveal the comparative % friability results obtained on unpolished tablets vis-a-vis that for the tablets polished with the dry polish composition of the present invention.
- the % friability is a very important factor in case of low dose drug products as even a marginal loss can lead to a large compromise in dosage and the product will not comply with the compendial standards.
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- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
This invention is in the field of polish compositions for edible substrates comprising of polyethylene glycol and /or its analogs, a plasticizer, a film former, a film detackifier and a glidant. Coating of substrates with the above composition imparts to the substrate a glossy appearance, reduces inter substrate friction and helps to minimize losses during packaging of the finished product.
Description
POLISH COMPOSITION
FIELD OF THE INVENTION
This invention is in the field of polish compositions for edible substrates comprising of polyethylene glycol and /or its analogs, a plasticizer, a film former, a film detackifier and a glidant. The composition can be used as a dry powder, or as an aqueous or non-aqueous suspension. Coating of substrates with the above composition imparts a glossy and shining appearance to the coated substrates and thus reduces the frictional effects between individual substrate particles after coating. This results in lesser chipping or fragmentation of the substrate during packaging, which is performed after coating and thus retains the integrity of the coated substrate by minimizing the frictional effects during subsequent operations.
Description of Prior Art
The present invention relates to a non-wax polish composition, used for coating of substrates, wherein the sunstrates are pharmaceutical dosage forms or confectionery piece.
Conventional wax polish compositions are solutions of wax in an organic solvent such as carbon tetrachloride or ether. However, these solvents give rise to processing problems because of their toxic, inflammable and non-environmental friendly nature. Moreover, inadvertent over use of wax based solutions may spoil the substrate by adhesion of excess wax to the surface. Conventional wax polishing using an aqueous based system may result in spoiling the surface of the substrate due to over-washing. U.S.Pat Nos.3438794, 5023108, 5389129, 5733575, 6013282, 6039976 and WO0109259 all discuss wax based polish compositions with their advantages. However it would be ideal to have a non-wax based polish composition capable of giving the same effect as that given by a wax based composition to avoid all the disadvantages of wax based compositions.
The present invention provides a polish composition that is not wax based and has the following advantages.
1. The composition can be used as a powder and as a reconstituted suspension.
2. The reconstitution can be in an aqueous or non-aqueous solvent or mixtures thereof.
3. It can be used in varying concentrations
4. It gives a gloss to the substrate that is similar to the one achieved with a wax based composition
5. It decreases thee frictional effects between the substrates and thus reduces losses due to mechanical factors during later operations like packaging
6. It helps to minimize the losses during packing and thus increases the overall yield efficiency during manufacture.
The composition of the present invention comprises of a polyethylene glycol, plasticizer, film former, detackifier and a glidant.
Optionally, the polish composition of the present invention may contain a suitable preservative active in the range of pH 3.0 to 7.0 and acceptable for food/pharmaceutical use.
The most preferred composition of our present invention is:
Polyethylene Glycol 6000 97.6%
Glycerin 2.0%
Hydroxypropylmethylcellulose (HPMC) 0.2%
Talc 0.2%
Preparation / Reconstitution of the dry polish composition:
Prepare an aqueous suspension of the above composition at a concentration of 0.2% of the total weight of the tablets to be coated and prepare a 20% solution in demineralized water by stirring it in water under stirring and then stir for a period of atleast 10 minutes till a uniform suspension is formed. Coat the substrate by the process of spraying the polishing suspension onto the substrates under the following coating parameters. Temperature of tablet bed at the beginning of spraying - 27 to 50 deg C. Inlet Air Blower and Temperature - Switch Off during spraying the polish suspension.
Temperature after spraying - 65 to 70 deg C.
The substrates are to be rotated in the coating pan after spraying is complete for atleast 15 minutes till they are completely dried.
The solid content of the solution and the weight gain during coating may be varied depending on the substrate and the desired final product.
The preferred composition may be reconstituted in a non-aqueous medium as follows: Prepare an non-aqueous suspension of the above composition at a concentration of 0.2% of the total weight of the tablets to be coated and prepare a 5% solution in a mixture of Isopropyl alcohol and dichloromethane by dispersing the dry polish composition in isopropyl alcohol under stirring and adding dichloromethane during stirring for a period of at least 10 minutes till a uniform suspension is formed. Coat the substrate by the process of spraying the polishing suspension onto the substrates under the following coating parameters:
Temperature of tablet bed at the beginning of spraying - 28 to 40 deg C. Inlet Air Blower and Temperature - Switch Off during spraying the polish suspension.
Temperature after spraying - 55 to 65deg C.
The substrates are to be rotated in the coating pan after spraying is complete for atleast 15 minutes till they are completely dried.
The solid content of the solution and the weight gain during coating may be varied depending on the substrate and the desired final product.
The preferred composition may be reconstituted in a hydro-alcoholic medium as follows:
Prepare a hydro-alcoholic suspension of the above composition at a concentration of
0.2% of the total weight of the tablets to be coated and prepare a 20% solution by dispersing the dry polish composition in water and adding isopropyl alcohol under stirring, followed by stirring for a period of at least 10 minutes till a uniform suspension is formed. Coat the substrate by the process of spraying the polishing suspension onto the substrates under the following coating parameters:
Temperature of tablet bed at the beginning of spraying - 28 to 45 deg C. Inlet Air Blower and Temperature Switch Off during spraying the polish suspension.
Temperature after spraying - 65 to 75deg C.
The substrates are to be rotated in the coating pan after spraying is complete for atleast 15 minutes till they are completely dried.
The solid content of the solution and the weight gain during coating may be varied depending on the substrate and the desired final product.
As mentioned in the advantages earlier the following examples reveal the comparative results in terms of the percentage loss seen after packing (either blister or strip) of core, placebo and coated tablets vis a vis tablets (core, placebo and coated) polished with the composition of the present invention:
EXAMPLE 2:
Gl impend e Tablets 1 mg
Batch Size: 1,00,000 nos. tablets
Packing of Unpolished Tablets Polished Tablets
Glimperide 1 mg Tablets 98,500 nos. 99,300 nos.
Percentage Loss 1.5 % 0.7 %
EXAMPLE 3:
Cetirizine HC1 Tablets 10 Mg
Batch Size : 1,00,000 nos. tablets
Packing of Film Coated Tablets Film Coated & Polished Tablets
Cetirizine HC1 Tablets 10 Mg 98,800 nos. 99,500 nos.
Percentage Loss 1.2 % 0.5 %
Example 4 :
Placebo Tablets
Batch Size : 1,00,000 nos. tablets
Packing of Core tablets Polished Tablets Placebo Tablets 98,500 nos. 99,700 nos. Percentage Loss 1.5 % 0.3 %
Example 5 :
Film Coated Placebo Tablets
Batch Size : 1,00,000 nos. tablets
Packing of Core tablets Polished Tablets
Film Coated Placebo Tablets 98,800 nos. 99,700 nos.
Percentage Loss 1.2 % 0.3 %
It can be seen above from the examples 2-5 that in case of all batches wherein the substrates were coated with the dry polish composition, the percentage loss during packing was much less and higher batch yields for the process were obtained.
To evaluate the losses that arise during friction between substrates friability is a test that is prescribed by the USP. The % friability gives an indication of the physical pressures that a tablet can withstand during further processising and there is a limit of 1 % so that product specifications are adhered to and the patient gets a quality product.
Examples 6-8 reveal the comparative % friability results obtained on unpolished tablets vis-a-vis that for the tablets polished with the dry polish composition of the present invention.
EXAMPLE 6: Glimperide Tablets 1 mg Batch Size: 1,00,000 nos. tablets Unpolished Tablets Polished Tablets
Friability 0.4 % 0.1 %
EXAMPLE 7:
Cetirizine HC1 Tablets 10 Mg
Batch Size : 1,00,000 nos. tablets Unpolished Tablets Polished Tablets
Friability 0.5 % 0.2 %
Example 8 :
Placebo Tablets
Batch Size : 1,00,000 nos. tablets Unpolished Tablets Polished Tablets
Friability 0.4 % 0.15 %
As seen from the comparative data in Examples 6-7 it can be seen that there is a fall in % friability for substrates coated with the composition of the present invention. This maybe attributed to the lower incidence of frictional effects because of easy intra and inter paniculate sliding due to the polishing effect.
The % friability is a very important factor in case of low dose drug products as even a marginal loss can lead to a large compromise in dosage and the product will not comply with the compendial standards.
Claims
1. A polish composition for coating edible substrates to impart a gloss thereto, consisting essentially of at least 50% by weight of a polyethylene glycol or its analog, 0-15% by weight of a plasticizer, 0-10% by weight of a cellulosic film former, 0-5% by weight of a detackifier and 0-5% by weight of a glidant.
2. A polish composition according to claim 1, wherein the edible substrate is a pharmaceutical dosage form or a food / confectionery item.
3. A polish composition according to claim 1, in which the polyethylene glycol is polyethylene glycol 6000.
4. A polish composition according to claim 1, in which the composition of polyethylene glycol or its analog is atleast 50% by weight of the composition.
5. A polish composition according to claim 1, in which the plasticizer is glycerin.
6. A polish composition according to claim 1, in which the composition of the plasticizer is from about 0-15% by weight of the composition.
7. A polish composition according to claim 1, in which the cellulosic film former is hydroxypropylmethylcellulose.
8. A polish composition according to claim 1, in which the composition of the film-former is from about 0-10% by weight of the composition.
9. A polish composition according to claim 1 , in which the detackifier is talc.
10. A polish composition according to claim 1, in which the composition of the detackifier is from about 0-5% by weight of the composition.
11. A polish composition according to claim 1, in which the glidant is talc.
12. A polish composition according to claim 1, in which the composition of the glidant is from about 0-5% by weight of the composition.
13. A polish composition for coating edible substrates to impart a gloss thereto, consisting essentially of at least 50% by weight of a polyethylene glycol or its analog, 0-15% by weight of a plasticizer, 0-10% by weight of a cellulosic film former, 0-5% by weight of a detackifier, 0-5% by weight of a glidant and optionally a preservative from 0.15 to 0.75% by weight of the composition.
14. A polish composition as in claim 13, wherein the preservative is active in the range of pH 3.0 to 7.0 and is acceptable for food / pharmaceutical use.
15. A method of decreasing the percentage losses before final packaging of a substrate by using a polish composition, consisting essentially of at least 50% by weight of a polyethylene glycol or its analog, 0-15% by weight of a plasticizer, 0-10% by weight of a cellulosic film former, 0-5% by weight of a detackifier and 0-5% by weight of a glidant.
16. A method of reducing friability for substrates which are pharmaceutical dosage forms by coating them with the polish composition, consisting essentially of at least 50% by weight of a polyethylene glycol or its analog, 0-15% by weight of a plasticizer, 0-10% by weight of a cellulosic film former, 0-5% by weight of a detackifier and 0-5% by weight of a glidant.
17. A process for preparing a polish composition by dry blending of ingredients in a food processor or "V" blender, the ingredients consisting essentially of at least 50% by weight of a polyethylene glycol or its analog, 0-15% by weight of a plasticizer, 0-10% by weight of a cellulosic film former, 0-5% by weight of a detackifier and 0-5% by weight of a glidant.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IB2004/000405 WO2005089719A1 (en) | 2004-02-25 | 2004-02-25 | Polish compositions |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IB2004/000405 WO2005089719A1 (en) | 2004-02-25 | 2004-02-25 | Polish compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2005089719A1 true WO2005089719A1 (en) | 2005-09-29 |
Family
ID=34993422
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2004/000405 WO2005089719A1 (en) | 2004-02-25 | 2004-02-25 | Polish compositions |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2005089719A1 (en) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4683256A (en) * | 1980-11-06 | 1987-07-28 | Colorcon, Inc. | Dry edible film coating composition, method and coating form |
| US5882707A (en) * | 1996-01-05 | 1999-03-16 | Bpsi Holdings, Inc. | Method of coating an edible substrate with sugar/syrup or sugarless solutions containing dry color concentrate |
| US6013282A (en) * | 1994-10-07 | 2000-01-11 | Bpsi Holdings, Inc. | Enteric film coating compositions, method of coating therewith, and coated forms |
| US6448323B1 (en) * | 1999-07-09 | 2002-09-10 | Bpsi Holdings, Inc. | Film coatings and film coating compositions based on polyvinyl alcohol |
| US20030017204A1 (en) * | 1999-02-08 | 2003-01-23 | Michael Augello | Edible coating composition |
-
2004
- 2004-02-25 WO PCT/IB2004/000405 patent/WO2005089719A1/en active Application Filing
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4683256A (en) * | 1980-11-06 | 1987-07-28 | Colorcon, Inc. | Dry edible film coating composition, method and coating form |
| US6013282A (en) * | 1994-10-07 | 2000-01-11 | Bpsi Holdings, Inc. | Enteric film coating compositions, method of coating therewith, and coated forms |
| US5882707A (en) * | 1996-01-05 | 1999-03-16 | Bpsi Holdings, Inc. | Method of coating an edible substrate with sugar/syrup or sugarless solutions containing dry color concentrate |
| US20030017204A1 (en) * | 1999-02-08 | 2003-01-23 | Michael Augello | Edible coating composition |
| US6448323B1 (en) * | 1999-07-09 | 2002-09-10 | Bpsi Holdings, Inc. | Film coatings and film coating compositions based on polyvinyl alcohol |
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