b.baby (nobu225) Translations

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nobu225 English → Japanese
Original Text

APIs are used for different drug product dosage forms. The limits for particles might also take into account the route of administration, e.g.
・Tablets, capsules for oral applications: minute amounts of particles pass the
gastrointestinal tract unchanged;
・Solutions for parenteral, inhaler, ophthalmic applications: normally the solutions are
filtered by the drug product manufacturer via very small pore size. Minute amounts of
particles are generally removed by that filtration step. Related Drug Product (vials,
ampules, syringes, solutions) are tested for particulate matter during QC release
testing;
・Inhalers (dry form): a tighter limit might be applicable due to this specific dosage
form;

Translation

APIは異なる製剤の調剤フォームで使われます。粒子の制限は管理方法を考慮に入れるのが良いでしょう。例えば、
・錠剤、口から服用するカプセルなど。微量の粒子が胃腸の管を通り、変化しない。
・非経口の溶剤、吸入器、眼科系の塗布。通常、溶剤は製剤製造業者によって小さな毛穴ほどのサイズへフィルターされる。微量の粒子はほとんどの場合そのフィルター処理で取り除かれる。関連製剤(小瓶、アンプル、注射器、溶剤)は、QCリリーステストの間、粒子状物質のためにテストされる。
・吸入器(乾燥型)。より厳しい制限は、この特別な調剤形式のために適用されるでしょう。