Abstract
Objective: The aim of the present study was to select excipients in an oral solid dosage form with a dry extract of round-leaved wintergreen (Pyrola rotundifolia L.) by using asymmetric, rotatable composite plan of the second-order (uniform plan No. 17).
 Methods: The tablets were prepared by using a direct compression method. The most important pharmaceutical factors selected were considered in more details at developing the optimal composition and technology of the studied tablets of the round-leaved wintergreen extract. Each one was studied at five levels using asymmetric, rotatable composite plan of the second order.
 Results: Increasing amounts of PROSOLV® EASYtab SP and croscarmellose sodium in the powder mass, its flowability decreases, and increasing amounts of Tablettose® 80 improves flowability. Increasing the amount of Tablettose® 80 in the tablets composition leads to improved uniformity. The strength of the tablets increased with increasing amounts of Neusilin® US 2 at different combinations of levels of the other three factors. When studying the effect of the amounts of croscarmellose sodium on the disintegration of tablets, it was found that the best disintegration values were obtained in the study of croscarmellose sodium at the upper level.
 Conclusion: Oral solid dosage form with dry extract of round-leaved wintergreen was successfully prepared by the direct compression method. The optimal composition of tablets was determined by the regression analysis.
Highlights
It is very important to prevent, diagnose and adequately treat all kidney diseases [1].Nowadays, searching for plants with a long history of usage, minor side effects and high tolerability, regardless of the age of patients, as well as the development of effective medications on their basis for prevention and treatment of urinary system disorders are the objects of interest in our society [3].Pyrola rotundifolia L. has a wide range of pharmacological activities: antimicrobial, diuretic, anti-inflammatory, and nephroprotective ones
Four of the best excipients have been identified, Neusilin® US 2, PROSOLV® EASYtab SP, sodium croscarmellose, Tablettose® 80, which were selected for further investigation and determination of optimal composition using asymmetric, rotatable composite plan of the second order
We have studied the following excipients in the development of the optimal composition of tablets: dry extract of round-leaved wintergreen, Neusilin® US 2(Fuji Chemical Industry Co., LTD, Japan), PROSOLV® EASYtab SP (JRS Parma LTD, Germany), croscarmellose sodium SOLUTAB® A (Roquette, France), Tablettose®80
Summary
It is very important to prevent, diagnose and adequately treat all kidney diseases [1].Nowadays, searching for plants with a long history of usage, minor side effects and high tolerability, regardless of the age of patients, as well as the development of effective medications on their basis for prevention and treatment of urinary system disorders are the objects of interest in our society [3].Pyrola rotundifolia L. has a wide range of pharmacological activities: antimicrobial, diuretic, anti-inflammatory, and nephroprotective ones. It is very important to prevent, diagnose and adequately treat all kidney diseases [1]. Nowadays, searching for plants with a long history of usage, minor side effects and high tolerability, regardless of the age of patients, as well as the development of effective medications on their basis for prevention and treatment of urinary system disorders are the objects of interest in our society [3]. Pyrola rotundifolia L. has a wide range of pharmacological activities: antimicrobial, diuretic, anti-inflammatory, and nephroprotective ones. Pyrola rotundifolia L., commonly known as round-leaved wintergreen, belonging to family Ericaceae. The technology of getting the dry extract of round-leaved wintergreen was developed. The complex of the pharmacological action of the dry extract has been confirmed, which allows using it for the treatment and prevention of the urinary system diseases
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