Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing
a technology of solid pharmaceutical preparation and treatment method, which is applied in the direction of pharmaceutical product form change, colloidal chemistry, coatings, etc., can solve the problems of reducing the commercial value, reducing the product yield, and affecting the identification function, so as to improve the abrasion resistance of print and/or printability, and improve the effect of the abrasion resistan
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example 1
Reference Example
Production of Film-coated Tablet Formulation (Unit: mg)
[0071]
plain tablet130.0(containing 4 mg of active ingredient)hydroxypropylmethylcellulose3.74 (74.8%)(TC-5; trademark)copolyvidon0.75 (15.0%)titanium oxide 0.5 (10.0%)yellow ferric oxide0.01 (0.2%) total135.0
[0072] Plain tablets were placed in a coating machine (Driacoater (Powrex Corporation) or Hicoater (Freund Corporation)), a film coating liquid containing TC-5, copolyvidon, titanium oxide and yellow ferric oxide at the above-mentioned weight ratios was sprayed with a spray nozzle while rotating the pan, and the tablets were dried by heated air supplied. This operation was repeated until the above-mentioned coating weight was achieved.
example 2
[0073] Pre-printing Treatment with Polyethylene Glycol-containing Aqueous Solution Formulation (Unit: mg)
Prepar. Ex. 1Prepar. Ex. 2Comp. Ex.film-coated tablet135.0135.0135.0(Reference Example)MACROGOL 40000.1(the Japan Pharmacopoeia)MACROGOL 60000.1(the Japan Pharmacopoeia)water(0.9)(0.9)carnauba wax0.008sorbitan mono-oleate0.04n-hexane(0.9625)
[0074] The film-coated tablets (6,000 tablets, 810 g) obtained in the above-mentioned Reference Example were placed in a Hicoater (Freund Corporation), and a 10 wt % aqueous solution of MACROGOL 4000 (the Japan Pharmacopoeia; molecular weight 2,600-3,800) (Preparation Example 1) or MACROGOL 6000 (the Japan Pharmacopoeia; molecular weight 7,300-9,300) (Preparation Example 2) in total 6.0 g, or a 0.79 wt % carnauba wax n-hexane solution (Comparative Example) in total 6.063 g was sprayed with a spray nozzle while rotating the pan to give respective tablets having the above-mentioned formulations.
[0075] The above-mentioned respective tablets we...
example 3
Experimental Example
Test of Print Abrasion Resistance of and Printing Failure Rate
[0076] The three kinds of tablets (500 tablets each) obtained in the above-mentioned Example 2 were visually observed to examine printing failure, and 100 tablets each were placed in 3K glass bottles, which were shaken at amplitude 40 mm, shaking speed 250 times / minute in a reciprocal shaker SR-IIw (Nihon Medical and Chemical instruments Co., Ltd.) to observe the level of abrasion of the print over time. The results are shown in Table 1.
TABLE 1Comp. Ex.Prep. Ex. 1Prep. Ex. 2appear-number of500500500ancetesttabletsClass D000(%)1)Class C000(%)Class Bin-2.000(%)completeprintprinting1.41.20.8staintotal3.41.20.8abrasion10 minprint isno change (±)no change (±)property2)scratchy,wholetablet isstained (+)30 minprint isprint isno change (±)scratchy,scratchy,wholewholetablet istablet isstained (++)stained (+)60 minprint isprint isprint isscratchy,scratchy,scratchy,wholewholewholetablet istablet istablet isst...
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