Development of formulations for vaginal gel carrier in the pharmacy: A regulatory and quality aspect
Razvoj formulacija nosača za vaginalne gelove u uslovima apoteke - aspekt kvaliteta i regulative
Апстракт
On the basis of the Law on Medicines and Medical Devices of the Republic of Serbia, a magistral medicine means a medicine prepared in the pharmacy according to a prescription (formula) for an individual patient - user. In practice, the more need is for ex tempore production of vaginal preparations in the pharmacy and galenic laboratory. Due to the small number of registered vaginal gel products on the world market, and even less on our own market, their production in the pharmacies is very important. The aim of this study was to examine the possibilities of development the vaginal gel carriers with different hydrophilic polymers, in the pharmacy, in accordance with the requirements of the European Pharmacopoeia. For their production we used three different mediums for gelation: Carbopol® 940, Carbopol® Ultrez 10 and Pemulen® TR 1 NF. All formulations show similar organoleptic properties during the observed period of time. Measured pH values of carrier formulations do not differ signifi...cantly compared to the normal pH values of vaginal fluid. Optimal value for viscosity has a formulation A1 (formulation with Carbopol® 940), thus that formulation is our recommendation for the development of vaginal gel carrier. Because of the complicated procedure of registration of the generic drug, recommended formulation for vaginal gel carrier, as magistral medicine, has a great importance for patients who require precise adjustment of therapy.
Na osnovu Zakona o lekovima i medicinskim sredstvima koji je na snazi u našoj zemlji, magistralni lek je lek izrađen u apoteci na osnovu recepta (formule) za određenog bolesnika - korisnika. U praksi se sve više javlja potreba za ex tempore izradom vaginalnih preparata u uslovima apoteka i galenskih laboratorija. Usled malog broja registrovanih preparata, tipa vaginalnih gelova, na svetskom tržištu, ali manje na našem, veoma je važna njihova magistralna izrada u uslovima apoteke. Cilj ovog rada bio je ispitivanje mogućnosti izrade nosača za vaginalne gelove sa različitim hidrofilnim gelirajućim sredstvima u uslovima apoteke u skladu sa zahtevima Evropske farmakopeje. Za njihovu izradu korišćena su sledeća gelirajuća sredstva: Carbopol® 940, Carbopol® Ultrez 10 i Pemulen® TR 1 NF. Sve tri formulacije pokazuju slična organoleptička svojstva u posmatranom vremenskom periodu. Izmerene pH vrednosti formulacija nosača ne odstupaju značajno u odnosu na normalnu pH vrednost vaginalne tečnosti.... Najoptimalniji viskozitet ima formulacija A1 (sa Carbopolom® 940), koja je ujedno i naša preporuka za nosač u izradi vaginalnih gelova. S obzirom na komplikovan postupak registracije generičkog leka, predložena formulacija nosača za vaginalne gelove, kao magistralnog leka, od velikog je značaja za primenu kod bolesnika kojima je neophodno precizno podešavanje terapije.
Кључне речи:
magistral medicine / carrier / vaginal hydrogel / legislation / viscosity / magistralni lek / nosač / vaginalni hidrogel / regulativa / viskozitetИзвор:
Acta Facultatis Medicae Naissensis, 2012, 29, 1, 23-30Издавач:
- Univerzitet u Nišu - Medicinski fakultet, Niš
Институција/група
PharmacyTY - JOUR AU - Stanković, Milica AU - Savić, Vesna AU - Marinković, Valentina PY - 2012 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1829 AB - On the basis of the Law on Medicines and Medical Devices of the Republic of Serbia, a magistral medicine means a medicine prepared in the pharmacy according to a prescription (formula) for an individual patient - user. In practice, the more need is for ex tempore production of vaginal preparations in the pharmacy and galenic laboratory. Due to the small number of registered vaginal gel products on the world market, and even less on our own market, their production in the pharmacies is very important. The aim of this study was to examine the possibilities of development the vaginal gel carriers with different hydrophilic polymers, in the pharmacy, in accordance with the requirements of the European Pharmacopoeia. For their production we used three different mediums for gelation: Carbopol® 940, Carbopol® Ultrez 10 and Pemulen® TR 1 NF. All formulations show similar organoleptic properties during the observed period of time. Measured pH values of carrier formulations do not differ significantly compared to the normal pH values of vaginal fluid. Optimal value for viscosity has a formulation A1 (formulation with Carbopol® 940), thus that formulation is our recommendation for the development of vaginal gel carrier. Because of the complicated procedure of registration of the generic drug, recommended formulation for vaginal gel carrier, as magistral medicine, has a great importance for patients who require precise adjustment of therapy. AB - Na osnovu Zakona o lekovima i medicinskim sredstvima koji je na snazi u našoj zemlji, magistralni lek je lek izrađen u apoteci na osnovu recepta (formule) za određenog bolesnika - korisnika. U praksi se sve više javlja potreba za ex tempore izradom vaginalnih preparata u uslovima apoteka i galenskih laboratorija. Usled malog broja registrovanih preparata, tipa vaginalnih gelova, na svetskom tržištu, ali manje na našem, veoma je važna njihova magistralna izrada u uslovima apoteke. Cilj ovog rada bio je ispitivanje mogućnosti izrade nosača za vaginalne gelove sa različitim hidrofilnim gelirajućim sredstvima u uslovima apoteke u skladu sa zahtevima Evropske farmakopeje. Za njihovu izradu korišćena su sledeća gelirajuća sredstva: Carbopol® 940, Carbopol® Ultrez 10 i Pemulen® TR 1 NF. Sve tri formulacije pokazuju slična organoleptička svojstva u posmatranom vremenskom periodu. Izmerene pH vrednosti formulacija nosača ne odstupaju značajno u odnosu na normalnu pH vrednost vaginalne tečnosti. Najoptimalniji viskozitet ima formulacija A1 (sa Carbopolom® 940), koja je ujedno i naša preporuka za nosač u izradi vaginalnih gelova. S obzirom na komplikovan postupak registracije generičkog leka, predložena formulacija nosača za vaginalne gelove, kao magistralnog leka, od velikog je značaja za primenu kod bolesnika kojima je neophodno precizno podešavanje terapije. PB - Univerzitet u Nišu - Medicinski fakultet, Niš T2 - Acta Facultatis Medicae Naissensis T1 - Development of formulations for vaginal gel carrier in the pharmacy: A regulatory and quality aspect T1 - Razvoj formulacija nosača za vaginalne gelove u uslovima apoteke - aspekt kvaliteta i regulative VL - 29 IS - 1 SP - 23 EP - 30 UR - https://hdl.handle.net/21.15107/rcub_farfar_1829 ER -
@article{ author = "Stanković, Milica and Savić, Vesna and Marinković, Valentina", year = "2012", abstract = "On the basis of the Law on Medicines and Medical Devices of the Republic of Serbia, a magistral medicine means a medicine prepared in the pharmacy according to a prescription (formula) for an individual patient - user. In practice, the more need is for ex tempore production of vaginal preparations in the pharmacy and galenic laboratory. Due to the small number of registered vaginal gel products on the world market, and even less on our own market, their production in the pharmacies is very important. The aim of this study was to examine the possibilities of development the vaginal gel carriers with different hydrophilic polymers, in the pharmacy, in accordance with the requirements of the European Pharmacopoeia. For their production we used three different mediums for gelation: Carbopol® 940, Carbopol® Ultrez 10 and Pemulen® TR 1 NF. All formulations show similar organoleptic properties during the observed period of time. Measured pH values of carrier formulations do not differ significantly compared to the normal pH values of vaginal fluid. Optimal value for viscosity has a formulation A1 (formulation with Carbopol® 940), thus that formulation is our recommendation for the development of vaginal gel carrier. Because of the complicated procedure of registration of the generic drug, recommended formulation for vaginal gel carrier, as magistral medicine, has a great importance for patients who require precise adjustment of therapy., Na osnovu Zakona o lekovima i medicinskim sredstvima koji je na snazi u našoj zemlji, magistralni lek je lek izrađen u apoteci na osnovu recepta (formule) za određenog bolesnika - korisnika. U praksi se sve više javlja potreba za ex tempore izradom vaginalnih preparata u uslovima apoteka i galenskih laboratorija. Usled malog broja registrovanih preparata, tipa vaginalnih gelova, na svetskom tržištu, ali manje na našem, veoma je važna njihova magistralna izrada u uslovima apoteke. Cilj ovog rada bio je ispitivanje mogućnosti izrade nosača za vaginalne gelove sa različitim hidrofilnim gelirajućim sredstvima u uslovima apoteke u skladu sa zahtevima Evropske farmakopeje. Za njihovu izradu korišćena su sledeća gelirajuća sredstva: Carbopol® 940, Carbopol® Ultrez 10 i Pemulen® TR 1 NF. Sve tri formulacije pokazuju slična organoleptička svojstva u posmatranom vremenskom periodu. Izmerene pH vrednosti formulacija nosača ne odstupaju značajno u odnosu na normalnu pH vrednost vaginalne tečnosti. Najoptimalniji viskozitet ima formulacija A1 (sa Carbopolom® 940), koja je ujedno i naša preporuka za nosač u izradi vaginalnih gelova. S obzirom na komplikovan postupak registracije generičkog leka, predložena formulacija nosača za vaginalne gelove, kao magistralnog leka, od velikog je značaja za primenu kod bolesnika kojima je neophodno precizno podešavanje terapije.", publisher = "Univerzitet u Nišu - Medicinski fakultet, Niš", journal = "Acta Facultatis Medicae Naissensis", title = "Development of formulations for vaginal gel carrier in the pharmacy: A regulatory and quality aspect, Razvoj formulacija nosača za vaginalne gelove u uslovima apoteke - aspekt kvaliteta i regulative", volume = "29", number = "1", pages = "23-30", url = "https://hdl.handle.net/21.15107/rcub_farfar_1829" }
Stanković, M., Savić, V.,& Marinković, V.. (2012). Development of formulations for vaginal gel carrier in the pharmacy: A regulatory and quality aspect. in Acta Facultatis Medicae Naissensis Univerzitet u Nišu - Medicinski fakultet, Niš., 29(1), 23-30. https://hdl.handle.net/21.15107/rcub_farfar_1829
Stanković M, Savić V, Marinković V. Development of formulations for vaginal gel carrier in the pharmacy: A regulatory and quality aspect. in Acta Facultatis Medicae Naissensis. 2012;29(1):23-30. https://hdl.handle.net/21.15107/rcub_farfar_1829 .
Stanković, Milica, Savić, Vesna, Marinković, Valentina, "Development of formulations for vaginal gel carrier in the pharmacy: A regulatory and quality aspect" in Acta Facultatis Medicae Naissensis, 29, no. 1 (2012):23-30, https://hdl.handle.net/21.15107/rcub_farfar_1829 .