Capsules

What is a capsule?

Solid preparations with hard/soft shells of various shapes and capacities, usually containing a single dose of active substance. Intended for oral administration

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Why are capsules used?

Oral route is convenient/safe. Chemical/physical stability. Accurate drug dosing. Convenient handling. Low cost of manufacturing/packaging/shipping. Difficult to tamper with (some capsules)

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Which size of hard gelatin capsules are suitable for oral delivery of neat active in pre-clinical studies?

PCcaps (size 0.02)

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Give examples of capsule composition

Gelatin. Bovine, porcine, fish. Alternate polymers - HPMC, Pullulan (polysaccharide polymer consisting of maltotriose units)

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Describe features of Coni-Snap gelatin capsules

Most common. Animal source. Mixture of water-soluble proteins derived from collagen. Contains 13-16% moisture (contributes to shell flexibility)

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What are the advantages of Coni-Snap gelatin capsules? (1)

Tapered rim on body engages easily with cap/problem-free closure. Dual snap-ring locking system provides leak-free containment. Air vents allow air to escape during filling on high-speed capsule filling machines

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What are the advantages of Coni-Snap gelatin capsules? (2)

Rounded hemi-spherical shape ends are stronger/more resistant to deformation at high speeds

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Describe features of gelatin structure

Self-gelling agent, extremely good film-forming polymer. Cooling of gelatin solution above minimum critical concentration (<40 degrees Celsius) results in 3D gel network

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Describe features of Vcaps Hypromellose

HMPC. Vegetarian alternative. Cellulose modified to make a film-forming material. 4-6% moisture

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Describe features of NPcaps Pullulan

Polysaccharide formed by fermentation. Pharmaceutical excipient/consumer products. Made from corn syrup. 12% moisture

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Why is HPMC used?

Strong film-forming polymer. Non-animal capsule. Ethical/cultural views. Used when gelatin is not suitable (moisture sensitive/hygroscopic formulations). Less capsules broken easily

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How are hard capsule shells made?

Gel solution preparation. Capsule dipping. Capsule drying. General filling process - feeding, orientation, opening, ejection, dosing, closer, ejection

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What do hard capsules contain?

Fill material (powders/pellets/tablets/semi-solids) - variety of combinations of dosage forms (most flexible dosage form)

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What are the advantages of hard capsules - combination products?

Possible to have combinations of single active with various coatings. Possible to have combinations of multiple actives

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Describe some of the advantages of capsules

Faster time to market (increased share). Ideal for toxic/unstable drug compounds. Well suited for poorly soluble compounds. Good for modified release/drug combinations (1 OD). Improved patient compliance. Capsules cannot split. Branding opportunities

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Describe how capsules provide faster time to market

Require fewer processing steps. Less time needed for process optimisation/documentation/equipment validation. Require fewer excipients (less time to select/evaluate/validate raw materials)

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Describe the formulation advantages of capsules

Requires fewer excipients, used for clinical trials. Versatility - filled with powder/pellets, filled alone/combination. Ideal for controlled release. Reduces stability of sensitive drugs. More efficient in pharmaceutical development

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Describe the advantages of capsules being ideal for high potency drugs

Powder - reduce risk of exposure to workers/no handle-in process (e.g. cancer drugs). Liquids/semi-solids - minimise airborne dust levels/lower risk of cross-contamination. Reduce capital requirements (facilities/air-handling/equipment)

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Describe the advantage of capsules improving stability of sensitive drug compounds

Encapsulation doesn't create high heat/pressure (heat-sensitive drugs readily formulated). Capsule walls are opaque (amenable to light-sensitive compounds). Less excipients (suitable for sensitive/highly reactive drugs)

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What are the advantages of multi-particulate formulations?

Disperse freely in GI tract, more uniform distribution of drug into bloodstream. Reduced inter/intra-patient variability. Maximise absorption. Minimise side effects (consumer benefit - 1 OD)

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Describe features of omeprazole pellets

Multi-particulates are the preferred formulation for enteric coated and modified release dosage forms due to their predictable gastric transit time

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Describe features of Asasantin/Aggrenox (controlled-release formulations)

Combination of 2 drugs incompatible with each other and require different release profiles. Acetylsalicylic acid (200 mg) immediate release mini-tablet. Dipyridamole 25 mg slow release pellets

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Describe features of dry powder inhalers

Convenient to handle. Higher pulmonary availability (inspiration generates sufficient fine particle flow). Check consumption. easy, propellant-free formulation. API for DPI is extending to peptides e.g. insulin

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Describe features of the technological advance for liquid formations in capsules

Offer a solution for cytostatics, low dosages, low mp. bad compression, oxidation sensitivity. Lipidic matrices can formulated into soft/hard liquid filled gelatin capsules (consider - critical point to prevent leakage/LEMS)

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Describe the process of liquid encapsulation by micro-spray sealing (LEMS)

Spray fluid into joint between capsule halves. Capillary action draws fluid up between cap and body. Re-moisturising lowers mp of gelatin. Gentle heat melts two gelatin layers (fusion to form impervious seal). Gelatin hardens at room temp/stored 24h

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Give reasons why patients prefer capsules

Masks taste/odour, smooth/glossy shell, rounded/narrow shape. Maintain strength/efficacy/potent in action. Avoid mixing medication. Colour combinations/size/logo/brands

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What are soft capsules?

Filled/sealed in one single operation. One piece hermetically sealed gelatin capsule (long shelf life). Softgels preferred by consumers.

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What are the benefits of soft capsules?

Good dosage precision/uniformity. Enhanced stability, long shelf life (minimal degrading of API, minimal influence of light/O2). Bio-organic certification. Unique shapes/sizes/forms. Easy to swallow. Neutral flavour/taste/wide range of ingredients

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Outline the process for manufacturing soft capsules - rotary die method

Oil/drug combined with heated gelatin/plasticizer/dye. Drug encapsulation in gelatin droplets. Cooled for gelatin solidification. Seamless capsules formed

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What is in the softgel mix?

Lipophilic liquids/oils. Semi-emulsifying oils. Pre-concentrate. Hydrophyllic liquids. Suspensions

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What are the attributes of Vegicaps compared with gelatin? (1)

Technical - improves F of BCS class II/IV compounds, enhance dose uniformity of low dose (potent) compounds, encapsulation of higher temp fill formulations, higher pH fill formulations, wider range of compatible fill excipients

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What are the attributes of Vegicaps compared with gelatin? (2)

Stability for sensitive actives with higher water content, safe/tamper evident. Patient - all natural (free of animal derivatives), diet/cultural/religious views, gluten/sugar free, easy to swallow

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What are the attributes of Vegicaps compared with gelatin? (3)

Available in a variety of colours/shapes/sizes/clarity, odor/taste free

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What does SMEDDS stand for?

Self-emulsifying drug delivery systems combined with enteric coated softgel

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What does LBDDSstand for?

Lipid-based drug delivery systems

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Capsules

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