Pharmaceutical Excipients - Lecture Notes - PDF

‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﺭﺍﻧﻳﻪ ﺍﻟﺣﻣﻭﻱ‪ ،‬ﻣﺎﺟﺳﺗﻳﺭ ﺻﻳﺩﻟﺔ ﺻﻧﺎﻋﻳﺔ‬ ‫ﺍﻟﻣﺣﺎﺿﺭﺓ ﺍﻟﺳﺎﺩﺳﺔ‬ ‫ﺍﻟﺳﻭﺍﻏﺎﺕ ﺍﻟﺻﻳﺩﻻﻧﻳﺔ‬ ‫‪Pharmaceutical Excipients‬‬ ‫ﻓﻲ ﺍﻷﺷﻛﺎﻝ ﺍﻟﺻﻠﺑﺔ‪ ،Solid‬ﻧﺻﻑ ﺍﻟﺻﻠﺑﺔ ‪ ،Semi‐solid‬ﻭﺍﻟﺳﺎﺋﻠﺔ...

‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﺭﺍﻧﻳﻪ ﺍﻟﺣﻣﻭﻱ‪ ،‬ﻣﺎﺟﺳﺗﻳﺭ ﺻﻳﺩﻟﺔ ﺻﻧﺎﻋﻳﺔ‬ ‫ﺍﻟﻣﺣﺎﺿﺭﺓ ﺍﻟﺳﺎﺩﺳﺔ‬ ‫ﺍﻟﺳﻭﺍﻏﺎﺕ ﺍﻟﺻﻳﺩﻻﻧﻳﺔ‬ ‫‪Pharmaceutical Excipients‬‬ ‫ﻓﻲ ﺍﻷﺷﻛﺎﻝ ﺍﻟﺻﻠﺑﺔ‪ ،Solid‬ﻧﺻﻑ ﺍﻟﺻﻠﺑﺔ ‪ ،Semi‐solid‬ﻭﺍﻟﺳﺎﺋﻠﺔ ‪Liquid‬‬ ‫‪١‬‬ ‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﺍﻟﺴﻮﺍﻏﺎﺕ ﺍﻟﺼﻴﺪﻻﻧﻴﺔ ‪Pharmaceutical Excipients‬‬ ‫ﻫﻲ ﻣﺎﺩﺓ ﺃﻭ ﻣﺠﻤﻮﻋﺔ ﻣﻦ ﺍﻟﻤﻮﺍﺩ ﻳﻔﺘﺮﺽ ﺃﻥ ﺗﻜﻮﻥ ﺧﺎﻣﻠﺔ ﺣﻴﻮﻳﺎ ً )ﻋﻠﻰ ﺟﺴﻢ ﺍﻹﻧﺴﺎﻥ‪،‬‬ ‫ﻭﺍﻟﺤﻴﻮﺍﻥ ﻭﻟﻴﺲ ﻟﻬﺎ ﺗﺄﺛﻴﺮ ﻋﻼﺟﻲ ﺃﻭ ﻓﻴﺰﻳﻮﻟﻮﺟﻲ(‬ ‫ﺗﻀﺎﻑ ﺇﻟﻰ ﺍﻟﻤﺎﺩﺓ ﺍﻟﻔﻌﺎﻟﺔ )ﺍﻟﺪﻭﺍء( ﻟـ‪:‬‬ ‫ ﺗﻌﻄﻴﻪ ﺍﻟﺸﻜﻞ ﺍﻟﺼﻴﺪﻻﻧﻲ ﺍﻟﻤﻨﺎﺳﺐ ‪ suitable‬ﻟﻠﺘﻨﺎﻭﻝ ‪ to take‬ﻭﺍﻟﺤﻔﻆ ‪storage‬‬ ‫ﻭﺍﻟﻘﺒﻮﻝ ‪ acceptability‬ﻣﻦ ﻗﺒﻞ ﺍﻟﻤﺮﻳﺾ‪.‬‬ ‫ ﻟﺘﺤﺴﻴﻦ ﺍﻟﺘﻮﺍﻓﺮ ﺍﻟﺤﻴﻮﻱ ‪ bioavailability‬ﻟﻠﺪﻭﺍء‪.‬‬ ‫ ﻁﺮﻳﻘﺔ ﺗﺤﺮﺭﻩ ﺑﺎﻟﺴﺮﻋﺔ ﺍﻟﻤﻨﺎﺳﺒﺔ‪ Release rate‬ﺃﻭ ﻓﻲ ﺍﻟﻤﻮﻗﻊ‪Release site‬‬ ‫ﺍﻟﻤﻄﻠﻮﺏ‪.‬‬ ‫ ﺇﻳﺼﺎﻟﻪ ﺇﻟﻰ ﺍﻟﻌﻀﻮ ﺍﻟﻤﻄﻠﻮﺏ ﻓﻲ ﺍﻟﺠﺴﻢ‬ ‫ ﺛﺒﺎﺗﻪ ﺑﺸﻜﻠﻪ ﺍﻟﺼﻴﺪﻻﻧﻲ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ )ﺍﻟﻌﻤﺮ ﻋﻠﻰ ﺍﻟﺮﻑ(‪.‬‬ ‫ﺍﻟﺴﻮﺍﻏﺎﺕ ﺍﻟﺼﻴﺪﻻﻧﻴﺔ ‪Pharmaceutical Excipients‬‬ ‫ ﻳﺆﺛﺮ ﺍﻟﺴﻮﺍﻍ ﻭﻁﺮﻳﻘﺔ ﺗﺤﻀﻴﺮ ﺍﻟﺪﻭﺍء ﻋﻠﻰ ﻓﻌﺎﻟﻴﺔ ﺍﻟﻤﺎﺩﺓ ﺍﻟﻔﻌﺎﻟﺔ ‪API‬‬ ‫ﺍﻟﺪﺍﺧﻠﺔ ﻓﻲ ﺗﺮﻛﻴﺐ ﺍﻟﺸﻜﻞ ﺍﻟﺼﻴﺪﻻﻧﻲ ﻣﻦ ﻣﺼﻨﻊ ﻷﺧﺮ‪ ،‬ﺭﻏﻢ ﻭﺟﻮﺩ ﺍﻟﻤﺎﺩﺓ‬ ‫ﺍﻟﻔﻌﺎﻟﺔ ﻧﻔﺴﻬﺎ‪ ،‬ﻭﻳﺆﺛﺮ ﻫﺬﺍ ﻋﻠﻰ ﺍﺳﺘﺠﺎﺑﺔ ﺟﺴﻢ ﺍﻹﻧﺴﺎﻥ ﻟﻬﺎ‪.‬‬ ‫ ﻭﻣﻊ ﺍﺧﺘﻼﻑ ﻁﺒﻴﻌﺔ ﺍﻟﺠﺴﻢ ﺑﻴﻦ ﺍﻷﻓﺮﺍﺩ‪ ،‬ﻧﺮﻯ ﺃﻥ ﻣﺮﻳﺾ ﻗﺪ ﺍﺳﺘﺠﺎﺏ‬ ‫ﻟﻠﺪﻭﺍء ﻭﺁﺧﺮ ﻟﻢ ﻳﺴﺘﺠﻴﺐ ﺭﻏﻢ ﺃﻥ ﺍﻟﻤﺎﺩﺓ ﺍﻟﻔﻌﺎﻟﺔ ﻫﻲ ﻧﻔﺴﻬﺎ‪.‬‬ ‫‪٢‬‬ ‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﺗﻘﺳﻳﻡ ﺍﻟﺳﻭﺍﻏﺎﺕ‬ ‫ ﺗﻘﺳﻡ ﺍﻟﺳﻭﺍﻏﺎﺕ )ﺍﻟﻣﺳﺗﺧﺩﻣﺔ ﻓﻲ ﺻﻳﺎﻏﺔ ‪ formulation‬ﺍﻷﺷﻛﺎﻝ ﺍﻟﺻﻳﺩﻻﻧﻳﺔ(‬ ‫ﺣﺳﺏ ﺗﺻﻧﻳﻑ ﺍﻷﺩﻭﻳﺔ ﺑﺎﻻﻋﺗﻣﺎﺩ ﻋﻠﻰ ﻗﻭﺍﻡ ﺍﻟﺷﻛﻝ ﺍﻟﺻﻳﺩﻻﻧﻲ ﺇﻟﻰ ﺳﻭﺍﻏﺎﺕ‬ ‫ﻣﺳﺗﺧﺩﻣﺔ ﻓﻲ ﺗﺣﺿﻳﺭ ﺍﻷﺷﻛﺎﻝ ﺍﻟﺻﻳﺩﻻﻧﻳﺔ‪:‬‬ ‫‪ -١‬ﺍﻟﺳﺎﺋﻠﺔ ‪Liquid dosage form‬‬ ‫‪ -2‬ﺍﻟﺻﻠﺑﺔ ‪Solid dosage form‬‬ ‫‪ -3‬ﻧﺻﻑ ﺍﻟﺻﻠﺑﺔ ‪Semi solid dosage form‬‬ ‫ﺍﻟﺴﻮﺍﻏﺎﺕ ﺍﻟﺼﻴﺪﻻﻧﻴﺔ ‪Pharmaceutical Excipients‬‬ ‫اﻟ ﻞ اﻟ ﻻﻧﻲ إﺿﺎﻓﺔ ﻟﻠ اد اﻟﻔﻌﺎﻟﺔ ﻣ اد أﺧ ﻟﻬﺎ و ﻔﺔ ﻣ دة ﻓﻲ‬ ‫ ‬ ‫اﻟ ﻞ اﻟ ﻻﻧﻲ ﺗ ﻰ اﻟ اﻏﺎت ‪ Excipients‬وﻣ ﻬﺎ‪:‬‬ ‫ﺗ‬ ‫‪Solubilizer‬ﻋﺎﻣﻝ ﻣﺳﺎﻋﺩ ﻋﻠﻰ‬ ‫‪Diluent/ Filler‬ﻋﺎﻣﻝ‬ ‫‪Colorants‬ﻣﻠﻭﻧﺎﺕ‬ ‫ﺍﻻﻧﺣﻼﻝ‬ ‫ﻣﺎﻟﺊ‪ /‬ﻣﻣﺩﺩ‬ ‫‪Suspending agent‬ﻋﺎﻣﻝ‬ ‫‪Emulsifiers‬ﻋﻭﺍﻣﻝ‬ ‫‪Flavors‬ﻣﻧﻛﻬﺎﺕ‬ ‫ﻣﻌﻠﻖ‬ ‫ﺍﺳﺗﺣﻼﺑﻳﺔ‬ ‫‪Sweeteners‬ﻣﺣﻠﻳﺎﺕ‬ ‫‪Preservatives‬ﻣﻭﺍﺩ ﺣﺎﻓﻅﺔ‬ ‫‪Stabilizer‬ﻣﺛﺑﺗﺎﺕ‬ ‫‪Thickening agent/ Viscosity increasing agent‬ﻋﺎﻣﻝ ﻣﺛﺧﻥ‪ /‬ﺭﺍﻓﻊ ﻟﻠﺯﻭﺟﺔ‬ ‫‪٣‬‬ ٢٨/٠٥/١٤٤٦ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Liquid Dosage Form ‫اﻟ ﺎﺋﻠﺔ‬ Solvents ‫ اﻟ ﻼت‬/‫ اﻟ ﯾ ﺎت‬-A.‫اﻟ ﺎﻟ ﻞ‬ ‫ ﺗ ﻌ ﻞ اﻟ ﻼت ﻓﻲ ﺗ‬ solutes ‫ ﻣ ﻣﺎدة ﻣ ا ﺔ‬Homogeneous Mixtures ‫ ﻣ ﺞ ﻣ ﺎﻧ‬: ‫ اﻟ ﻠ ل ﻫ‬ ‫ واﺣ أو ﻣ ﺞ ﻣ اﻟ ﯾ ﺎت )ﻣ ﯾ أو أﻛ ( ﻋﺎدة‬Solvent ‫أو أﻛ ﻓﻲ ﻣ ﯾ‬ ‫ ز ﻲ‬Aqueous ‫ )ﻣﺎﺋﻲ‬Liquids ‫ ﻓﻲ ﻣ ﻞ ﺳﺎﺋﻞ‬solids ‫ﺗ اب اﻟ اد اﻟ ﻠ ﺔ‬.‫( أو ﻓﻲ ﻣ ﺞ ﻣ ﻬﺎ‬Alcoholic ‫ ﻛ ﻟﻲ‬Oily Solvents types‫ﺃﻧﻮﺍﻉ ﺍﻟﻤﺬﻳﺒﺎﺕ‬ :‫ )ﺗ ﻠ أﻟﻔﺔ ﻟﻠ ﺎء( ﻣ ﺎﻟﻬﺎ‬Aqueous Solvents ‫ ﻗﺎﺑﻠﺔ ﻟﻠ ج ﻣﻊ اﻟ ﺎء‬/‫ ﻣ ﻼت ﻣﺎﺋ ﺔ‬-١ Water, Alcohol, Alcohol Benzyl, Alcohol Isopropyl, Acetone, Glycerin, Propylene glycol. :‫ ﻣ ﺎﻟﻬﺎ‬Non-Aqueous Solvents (Oils) ‫ ﻣ ﻼت ز ﺔ‬-2 Oils, Corn Oil, Cotton Seed Oil, Isopropyl Myristate (IPM), Mineral Oil, Olive Oil, Oleic acid : ‫ﺗ ﻌ ﻞ اﻟ ﻼت ﻓﻲ ﺗ‬ (..... ‫ ﻏ ﻻت ﻓ‬،‫ اﻣ ﻻت‬،‫ ﻗ رات ﻋ ﺔ‬،‫ﺔ أو أذﻧ ﺔ‬ ‫ ﻧﻘ ﻓ‬،‫ﻻﻧ ﺔ اﻟ ﺎﺋﻠﺔ )ﺷ ا ﺎت‬ ‫ اﻷﺷ ﺎل اﻟ‬.Coating Solutions ‫ﻣ ﺎﻟ ﻞ اﻟ ﻠ‬ ‫ ﺗ‬.Granulation Solutions ‫ﻣ ﺎﻟ ﻞ اﻟ‬ ‫ ﺗ‬ ٤ ‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﺎﺋﻠﺔ ‪Liquid Dosage Form‬‬ ‫‪ -B‬ﺍﻟﻤﻮﺍﺩ ﺍﻟﻤﺤﻤﻀﺔ ‪:Acidifying Agents‬‬ ‫‪Citric acid, Malic Acid, Tartaric acid, Acetic Acid.‬‬ ‫‪ -C‬ﺍﻟﻤﻮﺍﺩ ﺍﻟﻤﻘﻠﻮﻧﺔ ‪:Alkalizing agents‬‬ ‫‪Sodium hydroxide, Sodium bicarbonate, Sodium carbonate, Diethanolamine,‬‬ ‫‪Monoethanolamine.‬‬ ‫‪ -D‬ﺍﻟﻤﻤﺘﺰﺍﺕ ‪ Adsorbents‬ﻭﻣﺜﺎﻟﻬﺎ‪:‬‬ ‫‪Bentonite, Magnesium Aluminum Silicate, Magnesium Carbonate, Powdered Cellulose,‬‬ ‫‪Talc.‬‬ ‫ﺗﺴﺘﻌﻤﻞ ﻫﺬﻩ ﺍﻟﻤﻮﺍﺩ ﻻﺩﻣﺼﺎﺹ )ﺍﻣﺘﺰﺍﺯ( ‪ Adsorb‬ﺑﻌﺾ ﺍﻟﻤﻜﻮﻧﺎﺕ ﻋﻠﻰ ﺳﻄﺤﻬﺎ )ﻏﺎﺯﺍﺕ‪ ،‬ﺳﻮﺍﺋﻞ‪ ،‬ﺯﻳﺖ ﻋﻄﺮﻱ(‬ ‫ﻭﺫﻟﻚ ﺑﻔﻀﻞ ﻣﺴﺎﺣﺔ ﺳﻄﺤﻬﺎ ﺍﻟﻤﺮﺗﻔﻌﺔ ﺃﻭ ﻭﺟﻮﺩ ﺳﻼﺳﻞ ﺿﺨﻤﺔ ﻗﺎﺩﺭﺓ ﻋﻠﻰ ﺍﺳﺘﻴﻌﺎﺏ ﺍﻟﻤﻮﺍﺩ‪.‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﺎﺋﻠﺔ ‪Liquid Dosage Form‬‬ ‫‪ -E‬ﺍﻟﻤﻮﺍﺩ ﺍﻟﺪﺍﺭﺋﺔ‪ /‬ﺍﻟﻮﻗﺎءﺍﺕ ‪Buffering agents‬‬ ‫ﻳﺴﺘﻌﻤﻞ ﻣﺰﻳﺞ ﻣﻦ ﺣﻤﺾ ﺿﻌﻴﻒ ﻭﺃﺣﺪ ﺃﻣﻼﺣﻪ ﺃﻭ ﺃﺳﺎﺱ ﺿﻌﻴﻒ ﻣﻊ ﺃﺣﺪ ﺃﻣﻼﺣﻪ ﺑﻨﺴﺐ ﻣﺨﺘﻠﻔﺔ ﻟﺘﺤﻀﻴﺮ‬ ‫ﺃﻧﻮﺍﻉ ﻣﺨﺘﻠﻔﺔ ﻣﻦ ﺍﻟﻤﺤﺎﻟﻴﻞ ﺍﻟﺪﺍﺭﺋﺔ ﻣﺜﻼً‪:‬‬ ‫* ﺣﻤﺾ ﺍﻟﺒﻮﺭ )ﺑﺘﺮﻛﻴﺰ ‪ ١.٢٣٧‬ﻍ ‪ (%‬ﻭﺑﻮﺭﺍﺕ ﺍﻟﺼﻮﺩﻳﻮﻡ )ﺑﺘﺮﻛﻴﺰ ‪ ١.٩٠٧‬ﻍ ‪ (%‬ﺑﻨﺴﺐ ﻣﺌﻮﻳﺔ ﻣﺨﺘﻠﻔﺔ‬ ‫ﻟﻠﺤﺼﻮﻝ ﻋﻠﻰ ﻗﻴﻢ ﻣﻦ ﺍﻟـ ‪pH‬ﺗﺘﺮﺍﻭﺡ ﺑﻴﻦ ‪ ٦.٧٧‬ﻭ ‪.٩.١١‬‬ ‫* ﻣﺤﺎﻟﻴﻞ ﺳﻮﺭﻧﺴﻦ ‪ Sorensen‬ﺍﻟﻔﺴﻔﺎﺗﻴﺔ ﺍﻟﺪﺍﺭﺋﺔ‪ :‬ﻣﻜﻮﻧﺔ ﻣﻦ ﻣﺤﻠﻮﻟﻴﻦ‪ :‬ﻓﺴﻔﺎﺕ ﻭﺣﻴﺪﺓ ﺍﻟﺼﻮﺩﻳﻮﻡ ﺍﻟﻼﻣﺎﺋﻴﺔ‪،‬‬ ‫ﻭﻓﺴﻔﺎﺕ ﺛﻨﺎﺋﻴﺔ ﺍﻟﺼﻮﺩﻳﻮﻡ ﺍﻟﻼﻣﺎﺋﻴﺔ ﻹﻋﻄﺎء ﺩﺍﺭﺋﺔ ﺑﻘﻴﻢ ‪ ٥.٩ pH‬ﻭ ‪.٨‬‬ ‫‪٥‬‬ ‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﺎﺋﻠﺔ ‪Liquid Dosage Form‬‬ ‫‪ -E‬ﺍﻟﻤﻮﺍﺩ ﺍﻟﺪﺍﺭﺋﺔ‪ /‬ﺍﻟﻮﻗﺎءﺍﺕ ‪:Buffering agents‬‬ ‫ﺗﺴﺘﻌﻤﻞ ﻫﺬﻩ ﺍﻟﻤﻮﺍﺩ ﺍﻟﺪﺍﺭﺋﺔ )ﺍﻟﻤﺤﻤﻀﺔ ﻭﺍﻟﻤﻘﻠﻮﻧﺔ( ﻟـ‪:‬‬ ‫ ﺿﺒﻂ ﻗﻴﻤﺔ ‪ pH‬ﺍﻟﻤﺴﺘﺤﻀﺮ‪.‬‬ ‫ ﻟﻠﻤﺤﺎﻓﻈﺔ ﻋﻠﻰ ﺛﺒﺎﺕ ﺍﻟﻤﺎﺩﺓ ﺍﻟﻔﻌﺎﻟﺔ ﻓﻲ ﺍﻟﺸﻜﻞ ﺍﻟﺼﻴﺪﻻﻧﻲ‪.‬‬ ‫ ﺗﺤﺴﻴﻦ ﻣﻌﺪﻝ ﺫﻭﺑﺎﻧﻬﺎ‪.‬‬ ‫ ﺗﺤﺴﻴﻦ ﺍﻣﺘﺼﺎﺻﻬﺎ )ﺗﻮﺍﻓﺮﻫﺎ ﺍﻟﺤﻴﻮﻱ(‪.‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﺎﺋﻠﺔ ‪Liquid Dosage Form‬‬ ‫‪ -F‬ﻣﻮﺍﺩ ﻣﺜﺨﻨﺔ ‪ /‬ﻣ اد ﺭﺍﻓﻌﺔ ﻟﻠﺰﻭﺟﺔ ‪Viscosity Increasing Agents /Thickening Agents‬‬ ‫ﺗﺴﺘﻌﻤﻞ ﻓﻲ‪:‬‬ ‫‪‬ﺭﻓﻊ ﻟﺰﻭﺟﺔ ﺍﻟﻘﻄﺮﺍﺕ )ﺍﻟﻌﻴﻨﻴﺔ‪ ،‬ﺍﻷﺫﻧﻴﺔ‪ ،‬ﺍﻷﻧﻔﻴﺔ‪ (....‬ﻟﺰﻳﺎﺩﺓ ﻛﻤﻴﺔ ﺍﻟﻤﺎﺩﺓ ﺍﻟﻤﻤﺘﺼﺔ )ﻋﺒﺮ ﺯﻳﺎﺩﺓ ﺯﻣﻦ ﺍﻟﺘﻤﺎﺱ ﻣﻊ‬ ‫ﻣﻮﻗﻊ ﺍﻻﻣﺘﺼﺎﺹ(‪:‬‬ ‫‪Carboxymethylcellulose Sodium (CMC.Na), Hydroxyethyl Cellulose,‬‬ ‫‪Hydroxypropyl Cellulose (HPC), Hydroxypropyl methyl Cellulose (HPMC),‬‬ ‫‪Methyl Cellulose.‬‬ ‫‪‬ﺗﺴﺘﻌﻤﻞ ﻓﻲ ﺭﻓﻊ ﻟﺰﻭﺟﺔ ﺍﻟﺸﺮﺍﺑﺎﺕ )ﻟﺴﻬﻮﻟﺔ ﺳﻜﺐ ﺍﻟﺠﺮﻋﺔ ﻣﻦ ﺍﻟﻌﺒﻮﺓ(‪:‬‬ ‫ )‪Propylene Glycol, Glycerin (Co-Solvent‬‬ ‫ )‪Sucrose, Sorbitol (Sweetener Agents‬‬ ‫ ﺑﻌﺾ ﺍﻟﻤﺸﺘﻘﺎﺕ ﺍﻟﺴﻠﻮﻟﻮﺯﻳﺔ ‪Methyl Cellulose, CMC‬‬ ‫‪٦‬‬ ‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﺎﺋﻠﺔ ‪Liquid Dosage Form‬‬ ‫‪ -G‬ﻣ اد ُﻣ َ ﻠ ﺔ )ﺧﺎﻟ ﺔ ﻟﻠ ارد اﻟ ﻌ ﻧ ﺔ( ‪:Chelating Agents‬‬ ‫اﻟ اد اﻟﻔﻌﺎﻟﺔ‬ ‫ﺔ ﻟ ﻔﺎﻋﻼت اﻷﻛ ة ﻟ ﻌ‬ ‫ﺗﻌ ﻞ ﻋﻠﻰ ﺣ ‪/‬اﻟﻐﺎء اﯾ ﻧﺎت اﻟ ﺎﻟ م واﻟ ﻐ م اﻟ‬ ‫ات اﻟ ﺎﺋ ﺔ ﻣ ﻞ‪ :‬ﻣ ﺎﻟ ﻞ ﺣﻘ ‪ ،‬ﺷ ا ﺎت‪ ،‬ﻗ رات ﺄﻧ اﻋﻬﺎ اﻟ ﻠﻔﺔ‪ ،‬ﯾ ﻓﻊ ﺣ ﺎ ﺔ‬ ‫ﻓﺈﺿﺎﻓ ﻬﺎ ﻓﻲ اﻟ‬ ‫اﻟ اد اﻟﻔﻌﺎﻟﺔ اﻟ ﻠﺔ ﻣ ﺗﻔﺎﻋﻼت اﻷﻛ ة اﻟ ﻔ ة ﺎﻟ ارد‪.‬‬ ‫‪EDTA, Sodium Edetate, Citric Acid‬‬ ‫‪ -H‬ﻣ ﺎدات اﻷﻛ ة ‪:Antioxidants‬‬ ‫‪ ،‬أو اﻟ ور‬ ‫ﻣ ﺎدات اﻷﻛ ة ﺎرة ﻋ ﻣ اد ﻣ ﺟﻌﺔ‪ ،‬ﺗ ﺄﻛ ﺑ ﻻً ﻣ اﻟ اد اﻟﻔﻌﺎﻟﺔ‪ ،‬وﺗ ﻬﻠ اﻷﻛ‬ ‫ة اﻟ ﺟ د ﻓﻲ اﻟ ﺳ ‪ ،‬ﻓ ﻲ اﻟ اد اﻟﻔﻌﺎﻟﺔ ﻣ اﻟ ب‪.‬‬ ‫اﻟ ة اﻟ‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﺎﺋﻠﺔ ‪Liquid Dosage Form‬‬ ‫‪ -H‬ﻣ ﺎدات اﻷﻛ ة ‪:Antioxidants‬‬ ‫وﻧ ﻣ ﻬﺎ ﻧ ﻋ ‪:‬‬ ‫أ‪ -‬ﻣ ﺎدات أﻛ ة ﻟﻸوﺳﺎ اﻟ ﺎﺋ ﺔ وﻣ ﺎﻟﻬﺎ‪:‬‬ ‫‪Ascorbic Acid, Sodium Ascorbate, Sodium Metabisulfite, Sodium‬‬ ‫‪Sulfite‬‬ ‫ب‪ -‬ﻣ ﺎدات أﻛ ة ﻟﻸوﺳﺎ اﻟ ﺳ ﺔ وﻣ ﺎﻟﻬﺎ ‪:‬‬ ‫‪Butylatedhydroxyanisole (BHA), Butylated Hydroxytoluene (BHT),‬‬ ‫‪Tocopherol Acetate, Hydroquinone.‬‬ ‫‪٧‬‬ ‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﺎﺋﻠﺔ ‪Liquid Dosage Form‬‬ ‫‪ -I‬اﻟ اد ﺣﺎﻓ ﺔ ‪:Preservative‬‬ ‫ﺗ ﻌ ﻞ ﻫ ﻩ اﻟ اد ﻟ ﻔ اﻷﺷ ﺎل اﻟ ﻻﻧ ﺔ ﻣ ﻌ دة اﻟ ﻋﺎت ‪ Multiple Dose‬ﻣ اﻟ ﻠ ث‬ ‫ﺎﻟ ﻌ ﺎت اﻟ ﻘﺔ ‪) Micro-Organism‬ﻣ ﺎدات ﺟ اﺛ ‪،Antibacterial/Antimicrobial ،‬‬ ‫ﻣ ﺎدات ﻓ ر ‪.....(Antifungal‬‬ ‫أن ث اﻟ اﻟ ﺛ ﻣﻲ ‪ :‬أﺛ ﺎء اﻟ ﻔ ‪ ،‬أو أﺛ ﺎء اﻻﺳ ﻌ ﺎل‪.‬‬ ‫اﻷﺷ ﺎل اﻟ ﻻﻧ ﺔ ﻣ ﻌ دة اﻟ ﻋﺎت‪:‬‬ ‫‪‬اﻟ ا ﺎت ‪Syrups‬‬ ‫‪‬اﻟﻘ رات اﻟﻌ ﺔ ‪Eye Drops‬‬ ‫‪‬اﻟﻘ رات اﻷﻧ ﺔ ‪Nasal Drops‬واﻷذﻧ ﺔ ‪Ear Drops‬‬ ‫‪‬اﻟ اﻫ واﻟ ﺎت‬ ‫إﻣﺎ ﺗ ن‪ :‬ﻛﺎ ﺎت ﻟ اﻟ اﺛ ‪ Bacteriostatic‬أو ﻗﺎﺗﻠﺔ ﻟﻠ اﺛ ‪.Bacteriocidal‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﺎﺋﻠﺔ ‪Liquid Dosage Form‬‬ ‫‪ -I‬ﻣ اد ﺣﺎﻓ ﺔ ‪:Preservative‬‬ ‫ﺗﺄﺛ واﺳﻊ‪ ،‬أ ﻔ ﻞ أن ﺗ ن ﻓﻌﺎﻟﺔ‬ ‫أن ﺗ ﻊ اﻟ ﺎدة اﻟ ﺎدة ﻟﻠ اﺛ اﻟ ﻌ ﻠﺔ‬ ‫ﺗ ﺎﻩ اﻟﻔ ر‪ ،‬اﻟ ﺎﺋ ‪ ،‬اﻟ اﺛ إ ﺎﺑ ﺔ وﺳﻠ ﺔ اﻟﻐ ام‪.‬‬ ‫اﻟﻔﻌﺎﻟ ﺔ‪.‬ﻣ ﺎﻟﻬﺎ‪:‬‬ ‫ﻣ ﺎر ﺔ ﻋ ة ﻣ اد ﺣﺎﻓ ﺔ ﻣﻊ ﻌ ﻬﺎ ﻟ ﺎدة‬ ‫‪Alcohol‬‬ ‫‪Benzyl Alcohol‬‬ ‫‪Chlorobutanol‬‬ ‫‪Butylparaben, Methylparaben, Benzoic Acid, Sodium Benzoate‬‬ ‫‪Potassium Sorbate, Sorbic Acid‬‬ ‫‪Benzalkoniumchloride, Cetrimide, Chlorhexidine‬‬ ‫‪٨‬‬ ٢٨/٠٥/١٤٤٦ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Liquid Dosage Form ‫اﻟ ﺎﺋﻠﺔ‬ :Flavoring Agents ‫ ﻣ اد ﻣ ﻬﺔ‬-J ،‫ﺔ‬ ‫ ﻏ ﻻت ﻓ‬،‫ﺔ‬ ‫ ﻧﻘ ﻓ‬، ‫ أﻛﺎﺳ‬،‫ ﺷ ا ﺎت‬:‫ات اﻟﻔ ﺔ‬ ‫ﻌ اﻟ‬ ‫ﺗ ﻌﻞﻟ‬ :‫ وﻣ ﺎﻟﻬﺎ‬. ‫ وﻣ ﻐ ﺎت اﻟ‬،‫ ﻣ ﻐ ﺎت ﻣ ﻎ‬، ‫ﻏ اﻏ‬ ‫ اﻟ ت‬Juices (Blueberry) ‫ﻋ ق اﻟ س‬Extracts (Liquorices) Spirits (Lemon And Orange Spirit), Lemon Oil Spirit, Orange Oil Spirit Aromatic Water (Anise And Cinnamon) ‫ﻞ‬ ‫زﻧ‬Tinctures (Ginger) ‫ ﻧ ﻬﺎت ﺻ ﺔ‬Powder: Menthol, Banana ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Liquid Dosage Form ‫اﻟ ﺎﺋﻠﺔ‬ :‫ وﻣ ﺎﻟﻬﺎ‬:Pharmaceutical Coloring Agents ‫ اﻟ اد اﻟ ﻠ ﻧﺔ اﻟ ﻻﻧ ﺔ‬-K : Unsoluble Coloring Agents ‫ﻣ اد ﻣﻠ ﻧﺔ ﻏ ذوا ﺔ ﺎﻟ ﺎء‬ Iron Oxides CI 77491 (Red, Brown) ،Iron Oxides CI 77492 (Yellow)،Iron Oxides CI 77499 (Black). Β-Carotene (Yellow To Dark Orange). Caramel E 150, Titanium Dioxide (TiO2) (White). :Soluble Coloring Agents ‫ ﻣ اد ﻣﻠ ﻧﺔ ذوا ﺔ ﺎﻟ ﺎء‬ Erythrosine (Red No. 3) ،Tartrazine (Yellow No. 5)،Yellow Orange (Yellow No. 6) ،Sun Set Yellow (Orange). ٩ ٢٨/٠٥/١٤٤٦ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Solid Dosage Form ‫اﻟ ﻠ ﺔ‬ :Fillers ‫اﻟ اد اﻟ ﺎﻟ ﺔ‬Diluents ‫ة‬ ‫ اﻟ اد اﻟ‬-1.‫ﻐﺔ اﻟ واﺋ ﺔ‬ ‫ﺎً ﻓﻲ اﻟ‬ ‫( اﻟﻘﻠ ﻠﺔ ﻧ‬ ‫اﻟ ﺎدة اﻟﻔﻌﺎﻟﺔ )زﺎدة اﻟ‬ ‫ﺗ ﻌ ﻞ ﻫ ﻩ اﻟ اد ﻹﻛ ﺎل ﺣ‬ (ً‫ ﻣﻠﻎ ﻣ ﻼ‬٥) ‫ﺎت ﻗﻠ ﻠﺔ‬ ‫أ ﺗ ن اﻟ ﺎدة ذات ﻓﻌﺎﻟ ﺔ ﻋﻼﺟ ﺔ‬ :‫ ﻣ ﺎﻟﻬﺎ‬.‫د‬ ‫ﻻﻧﻲ اﻟ‬ ‫ ﻓﻲ اﻟ ﻞ اﻟ‬API‫ﻣ ﺗ ﺎول و دﺧﺎل اﻟـ‬ ‫ات ﻟﻠ‬ ‫ﯾ إﺿﺎﻓﺔ اﻟ‬ Lactose, Sugar, Mannitol, Sorbitol Calcium Carbonate, Calcium Phosphate, Tribasic Calcium Phosphate Starch, Microcrysatlline Cellulose: (Avicel PH 101, 102), Powdered Cellulose ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Solid Dosage Form ‫اﻟ ﻠ ﺔ‬ :Binders ‫ اﻟ اد اﻟ ا ﺔ‬-2 ‫ اﻟ ﻲ ﺗ ﺄ‬Granules ‫ أو ﻟ ﻞ اﻟ ات‬Powders ‫ ﺗ ﻌ ﻞ اﻟﻌ اﻣﻞ اﻟ ا ﺔ ﻓﻲ ر اﻟ ﺎﺣ‬ :‫ ﻣ ﺎﻟﻬﺎ‬.Tablets ‫اﻟ ﻐ ﺎت‬ ‫ أو ﺗ ﻐ ﻟ‬Capsules ‫ﻓﻲ اﻟ ﻻت‬ ‫اء‬ ‫ﺻ ﻎ اﻟ‬Tragacanth ‫ﻎ اﻟﻌ ﻲ‬ ‫ اﻟ‬Acacia ‫ﻪ‬ ‫ﺑ‬ ‫ اﻟ ﻼﺗ‬Gelatin ‫ﺎت‬ ‫ اﻻﻟ‬Alginic Acid, Sodium Alginate Carboxymethyl cellulose Sodium, Hydroxpropyl Methyl Cellulose(HPMC) Povidone K30, Povidone K90 (PVP). ١٠ ‫‪٢٨/٠٥/١٤٤٦‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﻠ ﺔ ‪Solid Dosage Form‬‬ ‫ ‪ -3‬اﻟ اد اﻟ ﻔ ﺔ ‪ /‬اﻟ ﻔ ﺔ ‪:Disintegrants‬‬ ‫‪.‬‬ ‫ﺎﺻﻬﺎ ﻟ ﺎدة ﺗ اﻓ ﻫﺎ اﻟ‬ ‫ﻊ اﻣ‬ ‫ﻐ ﺎت وﺗ ﻬ ﻞ ذو ﺎﻧﻬﺎ وﺗ‬ ‫ات واﻟ‬ ‫اﻟ‬ ‫ ﺗ ﻌ ﻞ ﻟﻔ‬ ‫ﻣ ﺎﻟﻬﺎ‪:‬‬ ‫‪Corn Starch‬‬ ‫‪Sodium Starch Glycolate‬‬ ‫‪Cross Povidone‬‬ ‫‪Cross Carboxymethyl cellulose‬‬ ‫‪Microcrystalline Cellulose‬‬ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ ‫اﻟ ﻠ ﺔ ‪Solid Dosage Form‬‬ ‫‪:Dusting Powder‬‬ ‫اﻟ ﻌﻔ‬ ‫ ‪ -4‬ﻣ ﺎﺣ‬ ‫ﻞ ﻋﺎم ﺎﻟ ﻟﻘﺎت‪ ،Lubricant‬أو ﻣ ﺎت اﻻﻧ ﺎﺑ ﺔ‪Anti-‬‬ ‫ ﯾ ﺟ ﻋ ة أﻧ اع ﻟﻬ ﻩ اﻟ ﺎﺣ وﺗ ﻰ‬ ‫ق اﻟ ﻌﻔ دو اًر ـ‪:‬‬ ‫أن ن ﻟ‬ ‫‪ Adherent‬أو ﻣ ﺎدات اﻻﺣ ﺎك ‪.Glidants‬‬ ‫ﻐ ﺎت أﺛ ﺎء ﺿﻐ اﻟ ﺎﺣ ﻓﻲ ُﺣ ة ﺿﻐ اﻷﻗ اص‪.‬‬ ‫ﺎق اﻟ‬ ‫ ﻫ ﻩ اﻟ اد ﺗ ﻊ اﻟ‬ ‫ﻻت(‪ ،‬وآﻻت‬ ‫اﻧ ﻻق اﻟ ﺎﺣ ﻓﻲ آﻻت اﻟ ﻌ ﺔ )ﻣ ﺎﺣ ‪ ،‬ﺣ ات‪،‬‬ ‫ ﺗﻌ ﻞ ﻫ ﻩ اﻟ اد ﻋﻠﻰ ﺗ‬ ‫اﻟ ﻐ ﺎت‪.‬‬ ‫ﺗ‬ ‫ة‪.‬ﻣ ﺎﻟﻬﺎ‪:‬‬ ‫ﺔ اﻻﻧ ﺎﺑ ﺔ واﻟ ﻌ ﺔ اﻟ‬ ‫ ﺗ ﺞ أﺷ ﺎل ﻣ ﺎﻧ ﺔ ﻓﻲ اﻟ ﻞ واﻟ زن ﻧ‬ ‫‪Magnesium Stearate (Ca), Stearic Acid‬‬ ‫‪Colloidal Silicon Dioxide (Aerosil), Magnesium Stearate, Starch, Talc‬‬ ‫‪١١‬‬ ٢٨/٠٥/١٤٤٦ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Solid Dosage Form ‫اﻟ ﻠ ﺔ‬ Direct Compression Excipients ‫ ﺳ اﻏﺎت اﻟ ﻐ اﻟ ﺎﺷ‬-5.‫ﻐ ﺎت‬ ‫اﻟ‬ ‫دون وﺟ د ﺳﺎﺋﻞ أو ﺣ ارة( ﻋ ﺗ‬/‫اﻟ ﺎﺣ )دون ﺗ ﻠ ﻞ‬ ‫ ﺗ ﻌ ﻞ ﻫ ﻩ اﻟ اد ﻟ‬.Granulation ‫ ﺗ ج اﻟ اد اﻟ اد ﺿﻐ ﻬﺎ ﻣﻊ ﺳ اﻏﺎت اﻟ ﻐ اﻟ ﺎﺷ وﺗ ﻐ دون إﺟ اء ﻋ ﻠ ﺔ اﻟ‬ :‫ﻣ ﺎﻟﻬﺎ‬ Microcrystalline Cellulose (Avicel) Cellulose Powder Dibasic Calcium Phosphate Ludipress (Lactose + Povidone K90 + Cross Povidone). ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Solid Dosage Form ‫اﻟ ﻠ ﺔ‬ :Film Formers ‫ ﻣ ﻼت اﻟﻔﻠ‬،Coating Agents / ‫اﻟ ﻐﻠ‬/ ‫ ﻣ اد اﻟ ﻠ‬-6 :‫ ﻣ ﺎﻟﻬﺎ‬.Matrix ‫ﻞ ﻣ س‬ ‫ﻐ ﺎت وﺗ‬ ‫اﻟ‬ ‫ات وﺗﻐﻠ‬ ‫اﻟ‬ ‫ ﺗ ﻌ ﻞ ﻟﻠ‬ * Extended (Sustained) Release Coating: Ethylcellulose, Carnauba Wax, Eudragit Rl, Eudragit Rs. *Enteric Coating: Microcrystalline Wax, Carnauba Wax, Shellac Gum , Hydroxypropyl Methylcellulose Phthalate, Eudragit L , Eudragit S. ١٢ ٢٨/٠٥/١٤٤٦ ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Semi Solid Dosage Form ‫ﻧ ﻒ اﻟ ﻠ ﺔ‬ Suppository Bases ‫اﻟ ﺎﻣ ﻞ‬ ‫ أﺳ‬- 1 Fatty Bases: Witepsol, Suppocire, Massa Estranium, White bees Wax, Theobroma Oil. Water Soluble And Water Miscible Bases: Glycerine-Gelatin Bases, Polyethylene Glycol (Macrogols) Bases. The Formula For Glycerol Suppository Base according to B.P. 14% Gelatin 70% Glycerol 100% Water To ‫ﻻﻧ ﺔ‬ ‫اﻷﺷ ﺎل اﻟ‬ ‫ﻣﺔ ﻓﻲ ﺗ‬ ‫أﻫ اﻟ اﻏﺎت اﻟ‬ Semi Solid Dosage Form ‫ﻧ ﻒ اﻟ ﻠ ﺔ‬ Ointment Bases ‫اﻟ ﻫ ﺔ‬ ‫ اﻷﺳ‬-2 Fatty/ Oleaginous Bases ‫ﺍﺳﺲ ﺩﺳﻤﺔ‬: Vaseline, Petrolatum, Paraffin Oil, Paraffin Wax. Absorbed Bases ‫ﺃﺳﺲ ﻣﺮﻫﻤﻴﺔ ﻣﻤﺘﺼﺔ‬: Lanolin, Cetostearyl Alcohol, Cetyl Alcohol, Stearyl Alcohol, Emulsifying Wax. Emulsified Bases ‫ ﺃﺳﺲ ﺍﺳﺘﺤﻼﺑﻴﺔ‬: (W/O Oint. Base) or (O/W Oint. Base). Water Soluble + Water Miscible Bases‫ﺃﺳﺲ ﻣﺰﻭﺟﺔ ﻣﻊ ﺍﻟﻤﺎء ﺃﻭ ﻣﻨﺤﻠﺔ ﺑﺎﻟﻤﺎء‬: Polyethylene Glycol (PEG). ١٣ ٢٨/٠٥/١٤٤٦ Simple Ointment Bp 50 g Wool Fat 50 g Hard Paraffin 50 g Cetostearyl Alcohol 850 g Yellow Or White Soft Paraffin Sulphur Ointment 100 g Precipitated Sulphur 900 g Simple Ointment ١٤