ﺗﻬﯿﻪ و ارزﯾﺎﺑﯽ ﭘﻠﺖﻫﺎي ﺣﺎوي ﻋﺼﺎره ﮔﯿﺎه ﺑﺎﺑﻮﻧﻪ داروﯾﯽ ﺑﺎ ﻃﻌﻢ ﭘﻮﺷﺎﻧﺪه ﺷﺪه

Development and evaluation of taste-masked pellets loaded with Matricaria chamomilla L. extract

ﻣﻘﺪﻣﻪ: ﺧﻮاص ﻗﺎﺑﻞ ﺗﻮﺟﻪ ﮔﯿﺎه ﺑﺎﺑﻮﻧﻪ داروﯾﯽ )ﺑﺎﺑﻮﻧﻪ ﺷﯿﺮازي( ﻣﻮﺟﺐ ﺷﺪه اﺳﺖ ﮐﻪ ﺑﻪ ﻃﻮر ﮔﺴﺘﺮدهاي در درﻣﺎن ﺑﯿﻤﺎريﻫﺎي ﻣﺨﺘﻠﻒ از ﺟﻤﻠﻪ اﺧﺘﻼﻻت ﮔﻮارﺷﯽ ﻣﻮرد ﺗﻮﺟﻪ ﻗﺮار ﮔﯿﺮد. ﻫﺪف: در ﻣﻄﺎﻟﻌﻪ ﺣﺎﺿﺮ، ﭘﻠﺖﻫﺎي روﮐﺶ داده ﺷﺪه ﺣﺎوي ﻋﺼﺎره ﺑﺎﺑﻮﻧﻪ ﺑﺎ ﻫﺪف ﭘﻮﺷﺎﻧﺪن ﻃﻌﻢ ﺗﻠﺦ آن، ﺑﻬﺒﻮد دوزﯾﻨﮓ و ﻧﯿﺰ ﭘﺬﯾﺮش ﺑﯿﻤﺎر ﺑﻪ وﯾﮋه در ﮐﻮدﮐﺎن، ﺳﺎﺧﺘﻪ ﺷﺪ. روش ﺑﺮرﺳﯽ: ﻋﺼﺎره ﮔﯿﺎه ﺑﻪ روش ﺧﯿﺴﺎﻧﺪن در اﺗﺎﻧﻮل % 70 اﺳﺘﺨﺮاج و ﺑﻪ روش ﺗﺒﺨﯿﺮ دوار و ﺧﺸﮏ ﮐﺮدن اﻧﺠﻤﺎدي ﺧﺸﮏ ﮔﺮدﯾﺪ. ﺳﭙﺲ ﺑﻪ ﻫﻤﺮاه ﻧﺴﺒﺖﻫﺎي ﻣﺨﺘﻠﻒ ﻣﻮاد اﻓﺰودﻧﯽ ﮔﻮﻧﺎﮔﻮن ﻣﺎﻧﻨﺪ آوﯾﺴﻞ، ﻧﺸﺎﺳﺘﻪ و ﻻﮐﺘﻮز ﺑﺮاي ﺗﻬﯿﻪ ﭘﻠﺖ ﺑﻪ روش اﮐﺴﺘﺮوژن - اﺳﻔﺮوﻧﺎﯾﺰﯾﺸﻦ ﻣﻮرد اﺳﺘﻔﺎده ﻗﺮار ﮔﺮﻓﺖ. ﭘﻠﺖﻫﺎ از ﻧﻈﺮ اﻧﺪازه، ﮐﺮوﯾﺖ، ﻧﺴﺒﺖ اﺑﻌﺎد و ﻓﺮﺳﺎﯾﺶﭘﺬﯾﺮي ﺑﺮرﺳﯽ ﺷﺪﻧﺪ. ﻓﺮﻣﻮﻻﺳﯿﻮن ﺑﻬﯿﻨﻪ، ﭘﺲ از اﻧﺠﺎم ﻓﺮاﯾﻨﺪ روﮐﺶدﻫﯽ ﺑﺎ اﺳﺘﻔﺎده از اودراژﯾﺖ E، از ﻧﻈﺮ ﮐﺎراﯾﯽ ﭘﻮﺷﺎﻧﺪن ﻃﻌﻢ، اﻧﺤﻼل و ﻣﻮرﻓﻮﻟﻮژي ارزﯾﺎﺑﯽ ﮔﺮدﯾﺪ. ﻧﺘﺎﯾﺞ: ﭘﻠﺖﻫﺎي ﺑﻬﯿﻨﻪ ﺑﺎ اﻧﺪازه ذرهاي، ﮐﺮوﯾﺖ و ﻧﺴﺒﺖ اﺑﻌﺎد ﺑﻪ ﺗﺮﺗﯿﺐ ﺑﺮاﺑﺮ ﺑﺎ 1/13 ﻣﯿﻠﯽﻣﺘﺮ، 0/924 و 1/172 ﺳﺎﺧﺘﻪ ﺷﺪﻧﺪ. ﻓﺮﺳﺎﯾﺶ ﭘﺬﯾﺮي ﮐﻢ، ﺟﺮﯾﺎنﭘﺬﯾﺮي )ﺷﺎﺧﺺ ﮐﺎر = 3/01 %( و ﻫﻤﭽﻨﯿﻦ اﻧﺤﻼل ﻣﻨﺎﺳﺐ ﻣﻮﺟﺐ ﮔﺮدﯾﺪ ﮐﻪ اﯾﻦ ﻧﻤﻮﻧﻪ ﺑﺮاي ﭘﻮﺷﺎﻧﺪن ﻃﻌﻢ ﺑﻪ روش روﮐﺶدﻫﯽ ﻣﻮرد اﺳﺘﻔﺎده ﻗﺮار ﮔﯿﺮد. ﺑﺮ اﺳﺎس ﻣﻄﺎﻟﻌﺎت اﻧﺤﻼل ﺑﺮونﺗﻦ، ﮔﺮﭼﻪ ﻻﯾﻪ روﮐﺶ ﺑﻪ ﻃﻮر ﻗﺎﺑﻞ ﺗﻮﺟﻬﯽ آزادﺳﺎزي اﺟﺰا را در pH ﺑﺎﻻﺗﺮ ﻧﺴﺒﺖ ﺑﻪ ذرات ﻓﺎﻗﺪ روﮐﺶ ﮐﺎﻫﺶ داد، وﻟﯽ اﻧﺤﻼل ﻗﺎﺑﻞ ﻗﺒﻮﻟﯽ در pH ﺑﺮاﺑﺮ ﺑﺎ 1/2 ﻣﺸﺎﻫﺪه ﺷﺪ. ﭘﻮﺷﺶ ﻣﻨﺎﺳﺐ ﻃﻌﻢ اﯾﻦ ﻓﺮآورده ﺑﺎ آﻧﺎﻟﯿﺰ درونﺗﻦ ﻧﯿﺰ ﺗﺎﯾﯿﺪ ﮔﺮدﯾﺪ. ﻧﺘﯿﺠﻪﮔﯿﺮي: ﭘﻠﺖﻫﺎي ﺣﺎوي ﻋﺼﺎره ﮔﯿﺎه ﺑﺎﺑﻮﻧﻪ داروﯾﯽ ﺑﺎ ﻃﻌﻢ ﭘﻮﺷﺎﻧﺪه ﺷﺪه و وﯾﮋﮔﯽﻫﺎي ﻣﻨﺎﺳﺐ ﻣﯽ ﺗﻮاﻧﺪ ﺳﺎﻣﺎﻧﻪ ﻣﻄﻠﻮﺑﯽ ﻫﻤﺮاه ﺑﺎ ﭘﺬﯾﺮش ﺑﺎﻻﺗﺮ ﺑﯿﻤﺎر ﺑﺎﺷﺪ.

Remarkable properties of Matricaria chamomilla L. (Mch) have caused it to be considered widely in the treatment of different ailments including gastrointestinal disorders. Objective: In the present study, the Mch extract-loaded coated pellets were developed with the aim to mask its bitter taste and to improve its dosing flexibility and patient compliance, especially in children. Methods: The plant extract was obtained by maceration with ethanol 70 % and dried using rotary evaporating and freeze drying methods. Then it was used for pellet preparation along with different proportions of various additives such as Avicel, starch and lactose by extrusion-spheronization technique. The pellets were analyzed for their size, sphericity, aspect ratio and friability. The optimized formulation, subjected for coating by Eudragit E, was evaluated for taste-masking efficiency, dissolution and morphology. Results: The optimized pellets were produced with particle size, sphericity and aspect ratio equal to 1.13 mm, 0.924 and 1.172, respectively. Low friability, suitable flow properties (carr’s index = 3.01 %) as well as dissolution led this sample to be considered for taste-masking coating. Based on in vitro dissolution studies, although the coating layer significantly decreased the release of the components at higher pH compared to the uncoated particles, acceptable dissolution was observed at pH 1.2. Appropriate taste-masking of the product was also confirmed by in vivo analysis. Conclusion: The taste-masked Mch-loaded pellets with suitable characteristics could be an appropriate delivery system with improved patient compliance.