Post-Marketing Quality Assessment and Comparative Dissolution Study of Some Ciprofloxacin Tablets Marketed in Mongolia

Судалгааны тайлбар: Variable quality of dosage forms of a wide range of drugs has often been reported, prompting the WHO to set standards for generic products. This study aimed to assess the quality and dissolution characteristics of generic ciprofloxacin 500 mg products available on the market, by comparison with a leading brand as well as to establish dissolution profiles in order to inform manufacturers and decision makers. A post-marketing quality assessment and comparative dissolution study of five generic ciprofloxacin products from different manufacturers available in Mongolia were completed. USP buffer at pH=1.2 (hydrochloric acid solution) and pH=4.5 (phosphate buffer solution) were dissolution media. In addition, weight variation, hardness, friability, disintegration time and assay were determined according to established methods. All five sampled products complied with the official specifications for uniformity of weight, friability and disintegration time. All five samples contained >99% (w/w) of labeled chemical content. However, significant inter and intra-brand variabilities in terms of dissolution rate were detected. As only two generic ciprofloxacin tablets included in this investigation were similar with the chosen comparator brand, the study concludes that further in vivo investigations are required to assess their bioequivalence.

Судалгааны мэдээлэл

pdf
Дундаж үнэлгээ
0 (0)
Үзсэн тоо
374
Татсан тоо
94
Файлын хэмжээ
599.53 KB
Оруулсан огноо
2023.04.05
Судалгаа хийгдсэн он
2020 он
Судалгааны салбар
Эрүүл мэндийн шинжлэх ухаан
Санхүүжилтийн эх үүсвэр
Гадаад, дотоодын хөрөнгө оруулалт
Гүйцэтгэгч байгууллага
Эм зүйн шинжлэх ухааны их сургууль ба бусад...
Захиалагч байгууллага
Эрүүл мэндийн яам
Эрүүл мэндийн яам bioethics@moh.gov.mn 51-264269 Эрүүл мэндийн яам

Сэтгэгдэл

Нэвтэрсэн хэрэглэгч сэтгэгдэл үлдээх боломжтой!

Хуваалцах

Энэ судалгааны ажлыг хуваалцахын тулд url хаягийг хуулж аваад найз руугаа илгээнэ үү.

Үнэлгээ өгөх

               

Зөрчил мэдэгдэх

Судалгаа