Designed and manufactured specifically for pharmaceutical capsule filling

Transcription

1 EXCIPIENTS Designed and manufactured specifically for pharmaceutical capsule filling Simple formulation Superior flow and weight uniformity Clean and efficient processing This document is valid at the time of distribution. Distributed -Ago-218 (UTC)

2 Uniquely Colorcon StarCap, co-processed starch excipient, simplifies formulation and improves processing of your capsule dosage form. With high flow and low adhesion, StarCap results in clean and efficient capsule filling operation. StarCap provides diluent and disintegrant functionality, reliable ph-independent dissolution, and aids long-term stability of reactive drugs. Designed Specifically for Pharmaceutical Use Manufactured in dedicated cgmp facilities, StarCap is a globally acceptable co-processed specialty excipient, comprising native and partially pregelatinized maize starch. Commonly used in capsule filling for its fast disintegration, native starch has inherently poor flow. By co-processing native starch with pregelatinized starch to create StarCap, the result is a free-flowing powder with excellent disintegration and compressibility for plug formation. The Natural Choice StarCap is 1% vegetable-derived and sourced from non-gmo corn, overcoming concerns associated with lactose and other milk derivatives, such as intolerance and BSE/ TSE issues. μm μm Native Starch (-1 µm) Native Starch Fast disintegration Poor flow Sticky on contact StarCap (average 9 µm) Partially pregelatinized starch Binding power Disintegrant compressibility Co-Process StarCap Free flowing Excellent compressibility for plug formation Low adhesion Fast disintegration This document is valid at the time of distribution. Distributed -Ago-218 (UTC)

3 Weight Consistency in High Speed Encapsulation Ensuring weight uniformity and enhancing powder flow are essential to effective capsule filling1. StarCap demonstrates smooth operation on high-speed production scale, continuous movement, dosator encapsulation equipment at 1, capsules per hour. In a case study, capsules were filled with StarCap, and weight measurements taken every minute, for 3 minutes. Low weight variation demonstrates that StarCap is highly applicable for high-speed capsule filling operations. 392 mg Max Fill 38 mg Target Fill 363 mg Min Fill RSD = 1.2% Reliable Dissolution ph Independent StarCap achieves rapid disintegration and ph-independent drug release profiles. Using a model drug, propranolol hydrochloride, both capsule disintegration and drug release were shown to be equivalent in high and low ph media. Capsule Dissolution: Gelatin Capsules filled with 2% Propranolol HCL / 8% StarCap Size 1 Gelatin Capsule Disintegration Time (n=6) 2% Propranolol HCl / 8% StarCap 1 Drug Released (%) Disintegration Time (minutes) ph6.8 buffer 2.1 N HCI ph 6.8.1N HCl 1 2 Time (minutes) 1. F. Muzzio, S. Stevemann, M. Richardson, J. Davidson, Capsule Manufacturing: Improving performance in product development and production, Pharmaceutical Processing, March 213. This document is valid at the time of distribution. Distributed -Ago-218 (UTC) 3

4 Dependable Stability The inert nature of StarCap also improves stability of propranolol hydrochloride, as a model drug, and brings formulation simplification with less chance of drug/excipient interaction. Size Capsules with % Propanolol HCl + 7% StarCap or Lactose. 4 C / 7% RH 1 Drug Released (%) After six months storage at accelerated stability conditions (4 C/7% RH) drug release from the capsule formulation with StarCap remained unchanged. However, the lactose-based formulation exhibited a measurable slowdown in release after 3 and 6 months. The inherent non-reactivity of StarCap contributes to maintaining dissolution profiles over time, resulting in dependable stability. 8 6 Initial - StarCap 3 mo - StarCap 6 mo - StarCap Initial - Lactose 3 mo - Lactose 6 mo - Lactose Time (minutes) 2 The natural choice for capsule applications - StarCap provides simple formulation, superior flow and weight uniformity, and efficient processing. From Core to Coating naturally Your Supplier of Choice This document is valid at the time of distribution. Distributed -Ago-218 (UTC) 3

5 Formulation Simplification StarCap replaces capsule filling excipient combinations, reducing formulation complexity without impacting drug release. Fewer ingredients lessen potential for interactions with the drug and reduce raw material testing and inventory. In a case study, a commercially marketed gabapentin capsule was reformulated with StarCap, replacing a blend of lactose, native starch, and talc. Gabapentin The simplified StarCap formulation meets USP monograph specifications for drug assay, fill weight variation, and drug dissolution. Gabapentin Assay USP Monograph Specification StarCap Formulation % % 8 Content Uniformity Relative Standard Deviation (RSD) NMT 6.% 1.3% Capsule Fill Weight Variation 9 11% % Gabapentin StarCap MgSt Gabapentin Innovator Capsule 6 Gabapentin +StarCap 4 2 NLT 8% in 3 min Gabapentin Dissolution Avg. % Drug Released Property Size gelatin capsules using a tamp filling machine at 3 capsules/hr. Lactose Starch Talc MgSt >8% in min 1 2 Time (min) 3 3 Superior Flow and Compressibility for Process Efficiency 3 Flow Rate (g/sec) Carr s Index (%) Higher powder flow rate and lower Carr s compressibility index are desirable for capsule weight consistency and clean filling operations. Compared to other commonly used capsule filling ingredients, StarCap combines superior flow and compressibility resulting in minimal dusting and low adhesion to contact surfaces..6 Native Starch MCC 9 micron Spray-Dried Lactose StarCap *Flow rate measured using Sotax FT 3 Flowability Tester, vibration setting 1.7g From Core to Coating naturally Your Supplier of Choice This document is valid at the time of distribution. Distributed -Ago-218 (UTC)

6 Deliver High Performance Products - with Colorcon Choose Colorcon, leader in pharmaceutical solid oral dose solutions, as a formulation partner of choice in every phase of your product development. Film Coatings: Optimized formulations specifically for your application and regulatory needs including customized colors and color matching Innovative products for mechanical integrity, gloss, pearlesence and environmental protection Tablet design concepts, consulting and services to build a strong brand image and stand out from the competition. Formulation Technologies: Full range of functional excipients Technologies for development and production of delayed/enteric release and extended/controlled release tablets and multiparticulates HyperStart service and extensive applications data to provide starting formulations to save you development time and money Extensive formulation know-how and technical support to achieve the exact drug release profile desired. Contact your Colorcon representative or call: North America Europe/Middle East/Africa +44-() Latin America India You can also visit our website at China BPSI Holdings LLC, 216. The information contained in this document is a proprietary to Colorcon, Inc. and may not be used or dissminated inappropriately All trademarks, except where noted are property of BPSI Holdings LLC. The information contained in this document is not intended as legal advice, and should not be relied upon for that purpose. pib_stcap_v1_1.216 Powered by TCPDF ( This document is valid at the time of distribution. Distributed -Ago-218 (UTC)