Abstract
The objective of this study was to evaluate a pH-dependent system of ileocolonic release of active ingredients using the polymer Eudragit® S100. A spouted bed was used in the coating process of soft capsules containing palm oil and of hard capsules containing glutamine under standardised experimental conditions. The height and diameter of the palm oil and glutamine capsules were measured using a calliper. The following variables were analysed: Eudragit® S100 dispersion amount used in the capsule coating process, nozzle air pressure, nozzle air flow rate, spray rate and temperature of the spouted bed coating process. The Eudragit® S100 dispersion formulation, trademarked as Quickstart® by Evonik Industries, was used with modifications to prepare the enteric coating. The results showed that the adequate temperature for the spouted bed coating process was 50°C and that 0.2 mL of 6.5% Eudragit® S100 coating per cm2 capsule was resistant for 60 minutes at pH 6.8. The findings demonstrate the pharmaceutical application of Eudragit® S100 in the modification of the coating and the preparation of a delayed-release system of hard and soft capsules, thus enabling ileal release of active ingredients.
Highlights
The following raw materials were used for manipulation of the enteric coating: - Glutamine capsules (ErliCaps Envase Ltda®, São Paulo, Brazil); - Palm oil capsules (Sorocaps®, Sorocaba, São Paulo, Brazil); - Anionic copolymer based on methacrylic acid and methyl methacrylate (Rohm, Pharma Polymers, Germany); - Distilled water (Biochemistry laboratory - Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil); - 28-30% Ammonium hydroxide (Dinâmica®, Diadema, São Paulo, Brazil); - Triethyl citrate (Neon®, São Paulo, Brazil); - Pure talc powder (Synth®, Diadema, São Paulo, Brazil); - Tartrazine yellow (Neon®, São Paulo, Brazil); - Absolute alcohol (Ciclo farma®, Serrana, São Paulo, Brazil)
Capsule size Eudragit® S100 dispersion amount used in the capsule coating process
To protect the active ingredients including palm oil and glutamine, which are susceptible to degradation at low pH values, the acrylate polymer known as Eudragit® S100 was used as a coating
Summary
Coating is defined as the process of applying a layer of material on a pharmaceutical form (solid surface) with a pharmaceutical composition (Martins & Oliveira, 2003). Coating is an adaptation of food preservation methods Pharmaceutical forms are primarily coated for active ingredient protection (Hampel, Buck, Peglow, & Tsotsas, 2013), and coating was first used by the pharmaceutical industry in 1953, when the Abbot Laboratory developed the first film coating (Lachman, Lieberman, & Kanig, 2001). Biodegradable pharmaceutical capsule coating is an emerging technology exploited by medicine and the pharmaceutical industry (Villanova, Oréfice, & Cunha, 2010). Numerous molecules are used as models for various pharmaceutical and food industry applications. Products based on methacrylic acid, acrylic acid and their derivatives are notable in the pharmaceutical industry (Shen et al, 2011)
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