Pediatrik dozaj formları için acı ilaçlara tat maskesi geliştirilmesi
Küçük Resim Yok
Tarih
2022
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Ege Üniversitesi, Sağlık Bilimleri Enstitüsü
Erişim Hakkı
info:eu-repo/semantics/embargoedAccess
Özet
İlaç etkin maddelerinin birçoğu, çocuklar için oldukça rahatsız edici olabilen karakteristik bir tada sahiptir. Farmasötik bir ürünün tadı, çocuk hastaların ilacı tekrar alma isteğini etkileyeceğinden, ilacın dozlamasında ve tedavi uyuncunda önemli bir parametredir. Pediatrik popülasyonda tadın, tedavi uyumu üzerinde etkisini göstermek adına birçok çalışma yayınlansa da henüz üretim aşamasında çocuk hastaların tat tercihlerine gereken birincil önem verilmemektedir. Farmasötik ürünün tadı, çocuğun tedaviye uyuncunu büyük ölçüde etkilemektedir. Bu yüzden etkin bir tedavi için uygulanacak ilacın tadının düzeltilmesi önemlidir. Oral yoldan yaygın olarak sıvı ve katı dozaj şekilleri kullanılmaktadır. Çözeltileri ve süspansiyonları içeren sıvı formülasyonlar için, kötü tadı azaltmaya yönelik teknik yaklaşımlar, tat maskeleme, çözünürlük modifikasyonu, adsorpsiyon, kompleksleştirme ve bariyer sistemleri olarak kategorize edilebilir. Tat maskeleme, genellikle mevcut olabilecek hoş olmayan tatları tam anlamıyla örtmek için kaplama, aroma ve/veya tatlandırma ajanlarının kullanımını içerir. Bu çalışmada oral kullanıma elverişli, pediatrik dozaj formu bulunmayan, keskin acı lezzetli bir antiprozoal ve antibakteriyel ilaç olan Ornidazol etkin maddesini model etkin madde olarak seçildi. Etkin madde, püskürterek kurutma (spray drying) tekniği ile ağız pH değerinde çözünürlüğü düşük olan Eudragit E PO ve Stearik asit polimerleriyle kaplanarak acı lezzet maskelendi. Ayrıca pediatrik hastalarda bir başka sorun olan yutma problemini çözmek ve dozlama kolaylığını sağlamak amacıyla toz şeklindeki kaplanmış etkin maddeden hareketle ağızda dağılan tablet (ODT) formülasyonu hazırlandı. Geliştirilen ODT'ler, farmakopelerin ve kılavuzların belirlediği in vitro kalite kontrol testleri ile değerlendirildi. Bu çalışma sonucunda hem ilaç endüstrisine yönelik yeni bir ürün hem de tadı acı olan benzer etkin maddelerin kaplanması ile ağızda dağılan tablet üretim yöntemi ve süreci ortaya çıkarılmıştır.
Many pharmaceutical active ingredients have a characteristic flavor that can be quite offensive to children. The taste of a pharmaceutical product is an important parameter in drug dosing and treatment compliance, as it will affect the willingness of pediatric patients to take the drug again. Although many studies have been published to show the effect of taste on treatment compliance in the pediatric population, the primary importance is not given to the taste preferences of pediatric patients at the production stage. The taste of the pharmaceutical product greatly affects the child's compliance with treatment. Therefore, it is important to correct the taste of the drug to be applied for an effective treatment. Liquid and solid dosage forms are commonly used orally. For liquid formulations containing solutions and suspensions, technical approaches to reducing off-taste can be categorized as taste masking, solubility modification, adsorption, complexation, and barrier systems. Taste masking often involves the use of coating, flavoring and/or sweetening agents to completely cover up any unpleasant tastes that may be present. In this study, Ornidazole active substance, which is an antiprozoal and antibacterial drug with a sharp bitter taste, suitable for oral use, without pediatric dosage form, was chosen as a model active substance. The bitter taste was masked by coating the active ingredient with Eudragit E PO and Stearic acid polymers, which have low solubility at oral pH, using the spray drying technique. In addition, an orally disintegrating tablet (ODT) formulation was prepared from the powder-coated active substance in order to solve the swallowing problem, which is another problem in pediatric patients, and to provide ease of dosing. Developed ODTs were evaluated with in vitro quality control tests determined by pharmacopoeias and guidelines. As a result of this study, a new product for the pharmaceutical industry and the production method and process of orally disintegrating tablets by coating similar active substances with a bitter taste were revealed.
Many pharmaceutical active ingredients have a characteristic flavor that can be quite offensive to children. The taste of a pharmaceutical product is an important parameter in drug dosing and treatment compliance, as it will affect the willingness of pediatric patients to take the drug again. Although many studies have been published to show the effect of taste on treatment compliance in the pediatric population, the primary importance is not given to the taste preferences of pediatric patients at the production stage. The taste of the pharmaceutical product greatly affects the child's compliance with treatment. Therefore, it is important to correct the taste of the drug to be applied for an effective treatment. Liquid and solid dosage forms are commonly used orally. For liquid formulations containing solutions and suspensions, technical approaches to reducing off-taste can be categorized as taste masking, solubility modification, adsorption, complexation, and barrier systems. Taste masking often involves the use of coating, flavoring and/or sweetening agents to completely cover up any unpleasant tastes that may be present. In this study, Ornidazole active substance, which is an antiprozoal and antibacterial drug with a sharp bitter taste, suitable for oral use, without pediatric dosage form, was chosen as a model active substance. The bitter taste was masked by coating the active ingredient with Eudragit E PO and Stearic acid polymers, which have low solubility at oral pH, using the spray drying technique. In addition, an orally disintegrating tablet (ODT) formulation was prepared from the powder-coated active substance in order to solve the swallowing problem, which is another problem in pediatric patients, and to provide ease of dosing. Developed ODTs were evaluated with in vitro quality control tests determined by pharmacopoeias and guidelines. As a result of this study, a new product for the pharmaceutical industry and the production method and process of orally disintegrating tablets by coating similar active substances with a bitter taste were revealed.
Açıklama
Anahtar Kelimeler
Ornidazol, Tat Maskeleme, Ağızda Dağılan Tablet (ODT), Eudragit E PO, Stearik Asit, Püskürterek Kurutma, Ornidazole, Taste Mask, Oral Dispersible Tablet (ODT), Eudragit E PO, Stearic Acid, Spray Drying
