JP3809292B2 - Sugar alcohol-containing tablet composition - Google Patents
Sugar alcohol-containing tablet composition Download PDFInfo
- Publication number
- JP3809292B2 JP3809292B2 JP07318899A JP7318899A JP3809292B2 JP 3809292 B2 JP3809292 B2 JP 3809292B2 JP 07318899 A JP07318899 A JP 07318899A JP 7318899 A JP7318899 A JP 7318899A JP 3809292 B2 JP3809292 B2 JP 3809292B2
- Authority
- JP
- Japan
- Prior art keywords
- sugar alcohol
- tablet composition
- weight
- tablet
- powder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
Description
【０００１】
【発明の属する技術分野】
本発明は、糖アルコール含有錠剤に関し、詳しくは、吸湿性の糖アルコール粉末を含有し、且つ、打錠機への付着がなく、直接打錠することが出来る錠剤組成物に関する。
【０００２】
【従来の技術】
砂糖や澱粉を賦形剤として使用する錠菓や錠剤の製造に際しては、従来から、原料粉体の固結を防止し、流動性を改善して製錠装置への充填性を良くすると共に、錠剤表面に光沢を与える滑沢剤として、ＨＬＢ２〜３のショ糖脂肪酸エステルが使用されている（特開昭４９−７４２１号公報、特開昭５５−３６０号公報など）。
【０００３】
近年、ダイエット食品の普及により、低カロリーで味質の優れた糖アルコールが広く使用されている。錠菓や錠剤においても、口腔内で速やかに崩壊する錠剤や、口腔内で噛み砕いて食感を楽しむチャアブル錠剤などの賦形剤として、糖アルコール粉末の使用が提案されている。
【０００４】
しかしながら、錠菓や錠剤に吸湿性の糖アルコールを使用する場合、打錠機への付着や充填率のバラツキが大きく、粉−粉混合系で効率的に直接打錠することが困難である。打錠機への付着防止のために多量の滑沢剤を添加することは、得られる錠剤の崩壊性に悪影響を及ぼすという問題がある。
【０００５】
【発明が解決しようとする課題】
本発明は上記実情に鑑みなされたものであり、その目的は、吸湿性の糖アルコール粉末を含有し、且つ、打錠機への付着がなく、直接打錠することが出来る糖アルコール含有錠剤組成物を提供することにある。
【０００６】
【課題を解決するための手段】
すなわち、本発明の要旨は、吸湿性の糖アルコールを５０重量％以上および溶融開始点が５０℃以上のショ糖脂肪酸エステルを含有して成ることを特徴とする糖アルコール含有錠剤組成物に存する。
【０００７】
【発明の実施の形態】
以下、本発明を詳細に説明する。本発明の錠剤組成物は、賦形剤として吸湿性の糖アルコール粉末を５０重量％以上含有することを要件とするが、その他、錠剤に使用される原料粉体としての各種の粉体が使用できる。例えば、エリスリトール等の他の糖アルコール、アスパルテーム、ステビア、スクラロース、アセスルファムＫ等の高甘味度甘味料、クエン酸などの酸味料、香料などの他、ビタミン、ミネラル等の各種機能性成分、各種の薬効成分を含む医薬粉末などを挙げることが出来る。
【０００８】
本発明において吸湿性の糖アルコールとしては、好適には、室温（２４℃）下、相対湿度７５％・２４時間での重量増加が１％以上である糖アルコールが使用され、例えば、ソルビトールやマルチトールなどが挙げられる。ソルビトールは高湿度となるほど吸湿による重量増加が大きく、上記の条件下でのソルビトールの重量増加は約５重量％である。また、マルチトールも略同程度以下であるが、湿度変化による重量変化はソルビトールよりも少ない。なお、砂糖は上記条件下では重量変化を示さず、エリスリトールは相対湿度９０％においても吸湿しないことが知られている。
【０００９】
本発明の錠剤組成物は吸湿性の糖アルコール粉末と共に滑沢剤として溶融開始点が５０℃以上のショ糖脂肪酸エステル（ＳＥ）を含有する。ＳＥとしては、特にＨＬＢが２〜３で粉砕品を主体とする粉体であるＳＥが好ましい。滑沢剤の溶融開始点は、ＤＳＣ（示差走査熱量分析計）で昇温２℃／分で測定したときの発熱ピークが立ち上がり始める温度であり、溶融開始点が５０℃未満の従来の滑沢剤、例えば、汎用されているＨＬＢ３のショ糖ステアリン酸エステル（溶融開始点約４７℃）等では、吸湿性の糖アルコールを多量に含む原料粉末の場合には、多量に添加しないと十分な効果が得られない。
【００１０】
ＳＥの構成脂肪酸としては、炭素数１８以上の飽和飽和脂肪酸、具体的には、ステアリン酸およびベヘン酸のエステルが好ましく、特にベヘン酸エステルの割合が約７０％以上であるＳＥが好ましい。また、粒径２０μｍ以下の微粉砕品が５０重量％以上含まれているＳＥを使用した場合は、粉体の流動性が向上し、均一に充填され、均一に圧縮成型されるので特に好ましい。
【００１１】
本発明の錠剤組成物における滑沢剤の含有量は、通常０．５〜４重量％、好ましくは１〜２重量％である。特に、粒径２０μｍ以下の微粉砕品が５０重量％以上含まれているＳＥを使用する場合は、滑沢剤の含有量が１重量％程度でも十分な効果が得られることが多い。
【００１２】
本発明の錠剤組成物は、通常、所定の割合で各成分を粉−粉混合することにより得られる。得られた組成物は、常法に従って打錠機で処理することにより錠剤とすることが出来る。錠剤の形状は、特に限定されず、例えば、丸型、平板、三角状など、目的に応じて任意の形状とすることが出来、その大きさも適宜選ぶことが出来る。
【００１３】
【実施例】
以下、本発明を実施例により更に詳細に説明するが、本発明は、その要旨を超えない限り、以下の実施例に限定されるものではない。なお、以下の実施例においては、滑沢剤として表１に示すショ糖脂肪酸エステルを使用した。
【００１４】
【表１】
実施例１〜２及び比較例１〜２
表２に示す配合（重量％）の粉体組成物を調製し、菊水製作所製打錠機を使用し、打錠圧６００ｋｇｆで丸型の錠剤（直径８ｍｍ、中央部厚さ４ｍｍ）の打錠試験を行った。結果を表３に示す。
【００１６】
【表２】
【表３】
実施例４及び５
表４に示す配合（重量％）の粉体組成物を調製して使用した他は、実施例１と同様にして錠剤試験を行ったところ、何れも10,000錠以上打錠可能であった。
【００１９】
【表４】
【発明の効果】
本発明によれば、付着性の強い吸湿性の糖アルコール粉末を含有し、且つ、打錠機への付着がなく、効率的に打錠することが出来る糖アルコール含有錠剤組成物が提供される。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a sugar alcohol-containing tablet, and more particularly to a tablet composition that contains a hygroscopic sugar alcohol powder and that can be directly compressed without adhesion to a tableting machine.
[0002]
[Prior art]
In the manufacture of tablet confectionery and tablets that use sugar or starch as an excipient, conventionally, the raw material powder is prevented from caking, improving the fluidity and improving the filling into the tablet making device, HLB 2-3 sucrose fatty acid esters are used as lubricants to give gloss to the tablet surface (JP 49-7421, JP 55-360, etc.).
[0003]
In recent years, sugar alcohols with low calories and excellent taste are widely used due to the spread of diet foods. Also in tablet confectionery and tablets, the use of sugar alcohol powder has been proposed as an excipient for tablets that disintegrate rapidly in the oral cavity and chewable tablets that can be chewed in the oral cavity to enjoy the texture.
[0004]
However, when a hygroscopic sugar alcohol is used for tablet confectionery or tablets, there are large variations in adhesion to the tableting machine and filling rate, and it is difficult to perform direct tableting efficiently in a powder-powder mixed system. Addition of a large amount of lubricant for preventing adhesion to a tableting machine has a problem of adversely affecting the disintegration property of the resulting tablet.
[0005]
[Problems to be solved by the invention]
The present invention has been made in view of the above circumstances, and an object of the present invention is to contain a sugar alcohol-containing tablet composition containing hygroscopic sugar alcohol powder and capable of direct tableting without adhering to a tableting machine. To provide things.
[0006]
[Means for Solving the Problems]
That is, the gist of the present invention resides in a sugar alcohol-containing tablet composition comprising a hygroscopic sugar alcohol of 50% by weight or more and a sucrose fatty acid ester having a melting start point of 50 ° C. or more.
[0007]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the present invention will be described in detail. The tablet composition of the present invention is required to contain 50% by weight or more of a hygroscopic sugar alcohol powder as an excipient. In addition, various powders as raw material powders used for tablets are used. it can. For example, other sugar alcohols such as erythritol, high sweetness sweeteners such as aspartame, stevia, sucralose, and acesulfame K, sour flavors such as citric acid, fragrances, various functional ingredients such as vitamins and minerals, various Examples thereof include pharmaceutical powders containing medicinal ingredients.
[0008]
As the hygroscopic sugar alcohol in the present invention, a sugar alcohol having a weight increase of 1% or more at a relative humidity of 75% and 24 hours at room temperature (24 ° C.) is preferably used. And tall. Sorbitol increases in weight due to moisture absorption as the humidity increases, and the weight increase of sorbitol under the above conditions is about 5% by weight. Maltitol is also about the same or less, but the weight change due to humidity change is less than that of sorbitol. It is known that sugar does not change in weight under the above conditions, and erythritol does not absorb moisture even at a relative humidity of 90%.
[0009]
The tablet composition of the present invention contains sucrose fatty acid ester (SE) having a melting start point of 50 ° C. or more as a lubricant together with hygroscopic sugar alcohol powder. As the SE, SE which is a powder mainly having a HLB of 2 to 3 and mainly a pulverized product is preferable. The melting start point of the lubricant is a temperature at which an exothermic peak starts to rise when measured by DSC (Differential Scanning Calorimetry) at a temperature rise of 2 ° C./min, and a conventional lubricant having a melting start point of less than 50 ° C. In the case of a raw material powder containing a large amount of a hygroscopic sugar alcohol, for example, a widely used HLB3 sucrose stearate ester (melting start point of about 47 ° C.), etc. Cannot be obtained.
[0010]
As a constituent fatty acid of SE, a saturated saturated fatty acid having 18 or more carbon atoms, specifically, an ester of stearic acid and behenic acid is preferable, and SE having a ratio of behenic acid ester of about 70% or more is particularly preferable. Further, when SE containing 50% by weight or more of a finely pulverized product having a particle size of 20 μm or less is used, it is particularly preferable because the fluidity of the powder is improved, and the powder is uniformly filled and uniformly compressed.
[0011]
The content of the lubricant in the tablet composition of the present invention is usually 0.5 to 4% by weight, preferably 1 to 2% by weight. In particular, when SE containing 50% by weight or more of a finely pulverized product having a particle size of 20 μm or less is used, a sufficient effect is often obtained even when the lubricant content is about 1% by weight.
[0012]
The tablet composition of the present invention is usually obtained by powder-powder mixing each component at a predetermined ratio. The obtained composition can be made into a tablet by processing with a tableting machine according to a conventional method. The shape of the tablet is not particularly limited. For example, the shape of the tablet can be any shape such as a round shape, a flat plate, or a triangular shape, and the size can be appropriately selected.
[0013]
【Example】
EXAMPLES Hereinafter, although an Example demonstrates this invention still in detail, this invention is not limited to a following example, unless the summary is exceeded. In the following examples, sucrose fatty acid esters shown in Table 1 were used as lubricants.
[0014]
[Table 1]
Examples 1-2 and Comparative Examples 1-2
A powder composition having the composition (% by weight) shown in Table 2 was prepared, and a round tablet (diameter: 8 mm, central thickness: 4 mm) with a tableting pressure of 600 kgf using a tableting machine manufactured by Kikusui Seisakusho. A test was conducted. The results are shown in Table 3.
[0016]
[Table 2]
[Table 3]
Examples 4 and 5
A tablet test was conducted in the same manner as in Example 1 except that a powder composition having the formulation (% by weight) shown in Table 4 was prepared and used.
[0019]
[Table 4]
【The invention's effect】
ADVANTAGE OF THE INVENTION According to this invention, the sugar alcohol containing tablet composition which contains a hygroscopic sugar alcohol powder with strong adhesiveness, does not adhere to a tableting machine, and can be tableted efficiently is provided. .
Claims (5)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP07318899A JP3809292B2 (en) | 1999-03-18 | 1999-03-18 | Sugar alcohol-containing tablet composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP07318899A JP3809292B2 (en) | 1999-03-18 | 1999-03-18 | Sugar alcohol-containing tablet composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2000264835A JP2000264835A (en) | 2000-09-26 |
| JP3809292B2 true JP3809292B2 (en) | 2006-08-16 |
Family
ID=13510927
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP07318899A Expired - Lifetime JP3809292B2 (en) | 1999-03-18 | 1999-03-18 | Sugar alcohol-containing tablet composition |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3809292B2 (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001061417A (en) * | 1999-08-25 | 2001-03-13 | Sanei Gen Ffi Inc | Powdery substance-containing composition |
| JP4261085B2 (en) * | 2001-05-31 | 2009-04-30 | クラシエフーズ株式会社 | An anti-pulverization agent for granules, a method for preventing granulation of granules, and a method for producing granules having anti-dusting properties. |
| JP2003095982A (en) * | 2001-09-27 | 2003-04-03 | Mitsubishi-Kagaku Foods Corp | Improver for feeling on tongue of sorbitol tablet molding |
| ATE311758T1 (en) * | 2001-10-18 | 2005-12-15 | Tokukura Co Ltd | GARNISH FOR CONFESSIONALS WITH EXCELLENT FAT TOLERANCE |
| JP4736509B2 (en) * | 2005-03-31 | 2011-07-27 | 小林製薬株式会社 | Candy |
-
1999
- 1999-03-18 JP JP07318899A patent/JP3809292B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JP2000264835A (en) | 2000-09-26 |
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