01 Clinical Supply
02 Clinical Supply
03 Clinical Supply
04 Clinical Supply
05 Controlled / Immediate / Modified Release
06 Controlled / Immediate / Modified Release
07 Controlled / Immediate / Modified Release
08 Controlled / Immediate / Modified Release
09 Controlled / Immediate / Modified Release
10 Controlled Substance
11 Controlled Substance
12 Enteric Coated
13 Hard Capsule
14 Hard Capsule
15 High Potency APIs (HPAPIs)
16 High Potency APIs (HPAPIs)
17 High Potency APIs (HPAPIs)
18 Immediate Release
19 Modified Release
20 Modified Release
21 Modified Release
42 Steroid / Hormone
01 AJES Pharmaceuticals, LLC
02 ANFARM HELLAS S.A.
03 AbbVie Contract Manufacturing
04 Adare Pharma Solutions
05 Aenova Group
06 Aesica Pharmaceuticals Limited
09 Athena Pharmaceutiques
11 Aurigene Pharmaceutical Services
12 Avara Pharmaceutical Services
13 Axxelent Pharma Science
14 BILCARE GCS
15 Bioindustria L.I.M. Spa
16 Biological E
17 Biopharma Srl
18 Biophore India Pharmaceuticals Pvt Ltd
19 Bioplus Life Sciences
20 Bliss Gvs Pharma Ltd
22 Bora Pharmaceuticals
23 Cambrex Corporation
24 Catalent Pharma Solutions
25 Chanelle Medical
26 Curtis Health Caps
27 Custom Pharma Services
28 Cyndea Pharma S.L
29 Delorbis Pharmaceuticals
30 Delpharm Group
31 Eurofins CDMO
33 Farbe Firma
35 Fermion Oy
36 Flagship Biotech International Pvt. Ltd
37 Fresenius Kabi Austria
38 Fulton Medicinali S.p.A
39 Glatt Pharmaceutical Services
40 Global Pharma CM Sp. z o. o
41 Globela Pharma
42 Gracure Pharmaceuticals Limited
44 HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO., LTD.
45 JGL d.d
46 JSC Olainfarm
47 Juniper Pharmaceuticals, Inc
48 Labiana Pharmaceuticals
49 Laboratoires Galéniques Vernin
51 Lifecare Neuro Products
52 Lonza Capsugel
53 Madras Pharmaceuticals
54 Medichem S.A
56 Mithra CDMO
57 Mycon Pharma
58 Nanjing Dorra Pharmaceutical Technology Co.,Ltd
60 ORIT LABS LLC
61 Olive Healthcare
62 One Pharma S.A
63 Orchid Pharma
64 Orofino Pharmaceuticals Group
66 Panacea Biotec Limited
67 Pfizer CentreOne
68 Pharmactive Pharmaceuticals
69 Pierre Fabre
70 Piramal Pharma Solutions
71 Polfa Tarchomin S.A
72 Priyans Drugs
73 Quotient Sciences
74 R-Pharm Germany GmbH
75 Rafarm S.A
76 Recipharm AB
77 Renown Pharmaceuticals
78 Ropack Inc
79 S.C. Rompharm Company SRL
80 Santa S.A
83 Siegfried AG
84 Sirio Pharma Co. Ltd
86 Societal CDMO
88 Softigel Procaps
89 Stason Pharmaceuticals, Inc.
90 Temad Co
91 Tianjin Hankang Pharmaceutical Biotechnology
92 Torrent Pharmaceuticals Limited
93 UPM Pharmaceuticals
94 Vici Health Sciences
95 WellSpring Consumer Healthcare
39 United Kingdom
40 United Kingdom
41 United Kingdom
Looking for a contract manufacturer for capsule manufacturing services? Find CDMO, CMO offering hardgel, softgel, veg capsule, etc. on PharmaCompass
In the pharmaceutical industry, capsules refer to solid dosage forms in which the drug is enclosed in a hard or soft soluble container. Capsules are usually administered orally, but occasionally may be administered rectally or vaginally.
Orally administered medications are hands down, the world’s preferred way to take medicines. For developers, oral solid dosage or OSD forms like tablets and capsules remain the preferred administration route due to their cost-effectiveness, relative ease of manufacturing and the wide availability of patient-friendly dosing options.
Capsules are generally made from special film-forming materials (such as gelatin, cellulose, polysaccharides, and pure natural plant starch, etc.), which are used to enclose ingredients in a relatively stable shell, allowing them to be taken orally.
Capsules may also be filled with a range of formulation types including dry powders, semisolids, nonaqueous liquids, and other dosage forms such as beads, mini-tablets, and even mini capsules.
Therefore, various types of capsules, with shells and inner fills made of different materials, are available in the market. Traditional capsules are principally made from gelatin, which is a common ingredient in medicines and food products.
Some Advantages of Capsules
- Capsules are tasteless, odorless, and can be administered easily. Drugs with unpleasant tastes and odors may also be enclosed in tasteless shells to make them more attractive to consumers.
- If properly stored the shells contain 12-15% of moisture which give flexibility and consequently very considerable resistance to mechanical stresses.
- Capsules can accommodate combinations of powders, and physicians may change the dose and combination of a capsule drug according to patient requirements.
- Presentation of a drug in a capsule rather than in tablets, allows quicker submission of a new drug for clinical trials because fewer development problems are involved.
- Other advantages of the capsule include the ability of an effective oxygen barrier and excellent chemical stability, which could improve product stability. For example, components that are unstable, sensitive to temperature, light and heat can be made into capsule forms.
Capsules are the dosage forms in which a drug formulation usually in a powder, semisolid, or liquid form is enclosed in a shell. This capsule shell is generally made from gelatin but can be made from other polymers such as hydroxypropyl methylcellulose (vegan capsules), polyvinyl alcohol (PVA), seaweed, or starch.
While there are a wide variety of capsules available in the pharmaceutical industry, hard capsules and soft capsules are the two most prolific capsule types in the market. Softgel capsules and hard gel capsules as well as their corresponding components are explored in detail below.
Soft gelatin capsules, also known as softgels or soft elastic capsules, are hermetically sealed one-piece capsules containing a liquid or a semisolid fill without an air or gas bubble. Softgels consist of two parts: solid capsule (outer shell) and a liquid or semi-solid center (inner fill). There are various softgel contract manufacturers that offer softgel capsule contract manufacturing services.
Softgel capsules offer several advantages such as delivering a liquid matrix designed to solubilize and improve the oral bioavailability of a poorly soluble compound, delivering low and ultra-low doses of a compound, delivering a low melting compound, and minimizing potential generation of dust during manufacturing, etc.
- Some Soft Capsule Outer Shell Ingredients
- Gelatin (e.g. bovine, porcine, piscine)
- Plasticizer (e.g. glycerin, sorbitol)
- Solvent (e.g. water)
- Flavoring agents (e.g. essential oils, sucrose)
- Colorants (e.g. dye, lakes)
- Preservatives (e.g. antioxidant agents, antimicrobial agents)
- Other additives
- Some Soft Capsule Inner Fill Materials
- Oily Mixtures
Hard Gelatin Capsules
Hard capsules are rigid, cylindrical shells typically made of two parts - the body and the cap - which are filled with dry or liquid ingredients and then specially sealed to prevent leakages. These are one of the oldest forms of the pharmaceutical capsule.
Hard capsules also offer several advantages: they are less expensive, easy to fill, able to meet different demands, have a longer shelf life, are easily digestible, have better bioavailability compared to tablets and allow a better degree of flexibility, amongst several other benefits.
- Some Hard Capsule Outer Shell Ingredients
- Gelatin (e.g. Type A and Type B)
- Colorants (e.g. dye, lakes, mineral colors)
- Opacifiers (e.g. Tio2)
- Plasticizer (e.g. sorbitol, glycerin)
- Preservatives (e.g. propyl and methyl parabens)
- Some Hard Capsule Inner Fill Materials
- Dry powders
Some Other Types of Capsules
- Veg Capsule or Vegan Capsule
HPMC capsules or veg capsules are two-piece capsules that serve as vegetarian alternatives to hard gelatin capsules and satisfy certain dietary and cultural needs. HPMC used in veg capsules or vegan capsules is considered safe for normal human consumption.
- Chewable Capsule
Chewable capsules are capsules designed to be chewed to release the active and/or inert ingredients. Chewable capsules are a versatile dosage form offering several advantages including oral drug delivery without the need for water, ease of swallowing, the stability advantages of solid dosage forms, and patient-centric drug delivery.
Capsule manufacturing starts with the dispense of raw materials, which then undergoes the process of granulation where sieving is done and various binders are added. This is followed by drying, sizing and blending of the materials.
This material then undergoes capsule filling techniques after which it goes for capsule polishing. After all that the capsules go for primary packaging (e.g. blister packaging) and then secondary packaging.
Manufacturing Capsules - Hard Gelatin Capsules
Hard gelatin capsules are fabricated and supplied empty to the pharmaceutical industry by empty shell suppliers, and are then filled in a separate operation. Manufacturing capsules involves a step by step process that requires strict quality control in the manufacture of hard gelatin capsules.
- Hard Gel Capsule Manufacturing Steps
Step 1: Preparation of gelatin solution (dipping solution)
Step 2: Dip-coating the gelatin solution on to metal pins (moulds)
Step 3: Rotation of the dip-coated pins
Step 4: Drying of the gelatin-coated pins
Step 5: Stripping and trimming
Step 6: Joining of the trimmed capsule shell
Step 7: Printing
Step 8: Developing and preparing the inner fill formulation
Step 9: Capsule filling using manual, semi automatic or automatic filling devices
Step 10: Sealing the filled hard capsules
Step 11: Cleaning and polishing the dry filled capsules
Manufacturing Capsules - Softgels
Soft gelatin capsules are made from a more flexible, plasticized gelatin film than hard gelatin capsules. A softgel consists of a gelatin-based shell surrounding a liquid fill. The shells are a combination of gelatin, water, opacifier, and a plasticizer, such as glycerin or sorbitol. In the encapsulation process, two flat ribbons are manufactured and brought together on a twin set of rotating dies.
- Softgel Capsule Manufacturing Steps
Step 1: Raw material storage and selection
Step 2: Weighing softgel capsule ingredients for inner and outer fills
Step 3: Preparation of inner fill materials
Step 4: Softgel encapsulation (Softgel capsule filling services)
Step 5: Drying
Step 6: Softgel dosage form inspection
Step 7: Soft shell capsule packaging
Step 8: Finished product storage and distribution
Some leading pharma contract manufacturers or capsule contract manufacturers that offer custom formulation and product development services for capsules, capsule filling techniques, (e.g. softgel capsule filling services), softgel capsule contract manufacturing and hard capsule contract manufacturing are noted below.
AbbVie Contract Manufacturing - Capsule Contract Manufacturing
AbbVie Contract Manufacturing, a leading pharma contract manufacturer and developer, offers contract manufacturing of various oral solid dosage forms such as capsules, over-encapsulation, bi-layer tablets, mini and micro tablets, liquids, pellets, granules, etc.
AbbVie Contract Manufacturing manufactures and packages finished drug products, with specific expertise in producing tablets, capsules, liquid-filled capsules, granules, prefilled syringes and oral liquids. Their manufacturing expertise includes tablet coating, spray coating, drying granulation, etc.
Skyepharma - Capsule Filling and Packaging
Skyepharma’s capsule manufacturing capabilities include capsules filled with tablets, granules, pellets, or powders. They offer blister packaging in PVC, PVDC, Aclar, Triplex, etc. and blister packaging services including serialization and aggregation. They also offer custom formulation and product development services for capsules and other dosage forms.
Pfizer CentreOne - Capsule Filling and Packaging
Pfizer CentreOne offers flexible oral solid dose manufacturing with various delivery technologies of capsules such as immediate-release capsules, modified-release capsules, powder-filled capsules, pellet-filled capsules, etc. It also offers other capsule filling and packaging services such as coating, blending, etc.
Polpharma - Hard Capsule Manufacturing
Polpharma is a leading capsule contract manufacturer offering contract manufacturing for various oral solid dosage forms such as hard gelatin capsules (filled with powders, pellets, granules) using various capsule filling techniques, soft gelatin capsules (i.e. softgel capsule contract manufacturing along with softgel capsule filling services), tablets, multilayer tablets, film and sugar coated tablets.
Its site in New Doba, Poland specializes in contract manufacturing dry oral formulations, including producing and packing tablets, coated tablets and hard gelatin capsules, in blisters (blister packaging) and polyethylene containers.
Recipharm AB - Hard Capsule Manufacturing
Recipharm has the capabilities to deliver your project from development through to the manufacture of large commercial batch sizes of tablets, capsules, hard gelatin capsules and powders. It is a leading capsule contract manufacturer offering custom formulation and product development services for capsules and various other dosage forms.
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Bora offers complex oral solid dosage forms, including immediate & extended-release capsules, multi-component capsules along with core tablets, sugar-coated tablets & aqueous & solvent film-coated tablets, at a commercial scale.
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Skyepharma offers bulk manufacturing of solid dosage forms like capsules filled with tablets, capsules filled with granules, film-coated tablets, immediate- or modified-release tablets, mono & multilayered tablets, tab-in-tab, granules, etc.
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Pfizer CentreOne offers flexible oral solid dose contract manufacturing with various delivery technologies for capsules such as immediate-release capsules, modified-release capsules, powder-filled capsules, pellet-filled capsules, etc.
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Quotient Sciences offers commercial manufacturing of capsules, tablets & small molecule products. Its batch sizes ranges from small scale (200g) to large scale (500kg) for capsule and tablet drug products.
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Temad offers the production of finished dosage products including various kinds of capsules & tablets from 2017 to achieve the most narcotics & non-narcotics market share in order to supply to domestic pharmaceutical companies and to the Middle East.
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