Dosage forms (also called unit doses) are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration (such as a capsule shell, for example), and apportioned into a particular dose or the manner in which the drug substance are available in the market (Eg.- solids, liquids etc). This blog will discuss the Capsule dosage form, its types, manufacturing, and advantages along with the latest development in the field.
CAPSULE
A capsule is a gelatinous envelope enclosing the active substance. Capsules can be designed to remain intact for some hours after ingestion in order to delay absorption. They may also contain a mixture of slow and fast release particles to produce rapid and sustained absorption in the same dose. Capsules include medication that’s enclosed in an outer shell. This outer shell is broken down in the digestive tract and the medication is absorbed into the bloodstream and then distributed and metabolized in much the same way as medication from a tablet.
Types of Capsules:
Hard-shelled Capsules:
The outside of a hard-shelled capsule consists of two halves. One half fits inside the other to form a closed casing. The inside is filled with dry medication in powder or pellet form.
Other hard-shelled capsules contain medication in liquid form. These are known as liquid-filled hard capsules (LFHC).
Airtight LFHCs make it possible for a single pill to contain more than one drug. Hence, they’re ideal for dual-action or extended-release formulas.
Soft-gel capsules have a slightly different appearance than hard-shelled capsules. They’re typically wider and are usually semi-transparent as opposed to opaque.
Also known as liquid gels, they contain medication suspended in gelatin or a similar substance. This substance is easily digested, at which point active ingredients are released and absorbed.
Advantages of Soft Gelatin Capsule
Manufacturing Materials:
As with hard gelatin capsules, soft gelatin capsules are predominantly administered orally. Some can be formulated and manufactured to produce a number of different drug delivery systems such as;
The process of encapsulation of hard gelatin capsules can be done on manual, semi-automatic and automatic capsule filling machines. Softgels are filled at the same time as they are produced and sealed on the rotary die of a fully automatic machine. Capsule fill weight is a critical attribute in encapsulation and various real times fill weight monitoring techniques such as near-infrared spectroscopy (NIR) and vibrational spectroscopy are used, as well as in-line weight checks, to ensure product quality.
The standard size of two shell Capsule:
Volume is measured to the fill line, which is customary to the top of the smaller-diameter body half. After capping, some unused volume (air space) remains in the finished capsule.
Drug-embedded in empty capsule shell: A new class of capsules has been developed where drugs can be embedded in the capsule shell matrix. This allows different drugs to be delivered using the same capsule. The drug might be in a solubilized form, suspended from, or chemically bound form in the capsule shell matrix. The drug can be in the cap of the capsule, body of the capsule or in both body and cap of the capsule. One can embed more than one drug in the capsule shell matrix. The drug can be in the dissolved and suspended form in the capsule shell matrix. Thus, one can create various types of variations in these "drug-embedded capsules". The rate of release of the drug can vary based on the way drug is embedded in the capsule shell matrix and drug properties.
The technology used in Capsule:
Capsule endoscopy is a procedure used to record internal images of the gastrointestinal tract for use in medical diagnosis. Newer developments are also able to take biopsies and release medication at specific locations of the entire gastrointestinal tract. The capsule (aka pill cam) is similar in shape to a standard pharmaceutical capsule, although a little larger, and contains a tiny camera and an array of LEDs powered by a battery. After a patient swallows the capsule, it passes along the gastrointestinal tract taking a number of images per second which are transmitted wirelessly to an array of receivers connected to a portable recording device carried by the patient. The primary use of capsule endoscopy is to examine areas of the small intestine that cannot be seen by other types of endoscopy such as colonoscopy or esophagogastroduodenoscopy (EGD).
Medical Uses:
Esophagogastroduodenoscopy (EGD), employs a camera attached to a long flexible tube to view the upper portion of the gastrointestinal tract, namely the esophagus, the stomach and the beginning of the first part of the small intestine called the duodenum, and a colonoscopy, inserted through the rectum, can view the colon and the distal portion of the small intestine, the terminal ileum, however, these two types of endoscopy cannot visualize the majority of the middle portion of the small intestine. Capsule endoscopy is used to examine parts of the gastrointestinal tract that cannot be seen with other types of endoscopy. It is useful when the disease is suspected in the small intestine, and can sometimes be used to find the site of gastrointestinal bleeding or the cause of unexplained abdominal pain, such as Crohn's disease. However, unlike EGD or colonoscopy, it cannot be used to treat pathology that may be discovered. Common reasons for using capsule endoscopy include diagnosis of unexplained bleeding, iron deficiency, or abdominal pain, searching for polyps, ulcers, and tumors of the small intestine, and diagnosis of inflammatory bowel disease. The images collected by the miniature camera during a session are transferred wirelessly to an external receiver worn by the patient, using any one of a band of appropriate frequencies. The collected images are then transferred to a computer for display, review, and diagnosis. A transmitted radio-frequency signal can be used to accurately estimate the location of the capsule and to track it in real-time inside the body and gastrointestinal tract. It is unclear if capsule endoscopy can replace gastroscopy for those with cirrhosis.
Side Effects:
Capsule endoscopy is considered to be a very safe method to determine an unknown cause of a gastrointestinal bleed. The capsule is usually excreted with the feces within 24–48 hours. There has been a report of retention of the capsule for almost four and a half years although the patient was asymptomatic. However, the risk of bowel obstruction may be countered by an abdominal X-ray to locate the device for removal by endoscopy or surgery.
Capsules remain popular as dosage forms, due to the various advantages afforded both to the manufacturer and to the patient. Capsules can be designed to remain intact for some hours after ingestion in order to delay absorption. They may also contain a mixture of slow and fast release particles to produce rapid and sustained absorption in the same dose.
Career Scope & Job Opportunities in the Pharmacy field are huge. Due to the opening of large pharmaceutical companies, the future in the field of pharmacy is bright.
Numerous jobs are available for pharmacists in government as well as private organizations. After completing your studies, you can easily find jobs in pharmaceutical industries, government departments, colleges and universities, hospitals, investigation and research institutes, etc.
Pharmacists can practice in community pharmacies, hospitals, clinics, extended care facilities, psychiatric hospitals, and regulatory agencies. The sales & Marketing job sector also hires the maximum number of pharmacy graduates.
One can also work in retail stores of medicines. After registering with the state Pharmacy Council, you can open chemist/drug shop and sell medicines as per Doctor’s prescription.
Pharmacists play a vital role in improving patient care through the medicine and information they provide. In addition, the pharmacy has excellent earning potential and is consistently ranked as one of the most highly trusted professions due to the care and service pharmacists provide.
About The Author:
Mr. Satyam Khare
Asst. Prof.
Corporate Institute of Pharmacy, Bhopal
satyamkhare88@gmail.com
+91 8878414505
The Need for Dosage Forms
Apart from ensuring safe and convenient delivery of the required dose of drug substances to the sites of action, dosage forms are needed for the following additional reasons:- To achieve a rapid onset of action following drug delivery e.g., parenteral dosage forms, inhalational/ respiratory dosage forms.
- To mask the undesirable taste or offensive odor of a drug substance e.g., capsules, taste-masked suspensions, coated tablets, etc.
- To achieve improved bioavailability, modified disposition as well as drug targeting e.g., Nanosuspensions.
- To provide drug products that are stable, effective, and safe for consumption under specified suitable storage conditions e.g., powders for reconstitution.
- To protect the drug molecules from the destructive influence of gastric juice following oral administration of the dosage forms e.g., enteric-coated tablets.
- To provide drug products that bypass the first-pass metabolism e.g., injections, topical dosage forms, etc.
- To provide drugs with a predetermined rate and prolonged therapeutic effect over an extended period of time e.g., modified-release tablets, capsules, and suspensions.
- To provide drug products that bind to a specific physiological site of action e.g., targeted-release tablets, capsules, etc.
- To provide a useful dosage form for administering poorly water-soluble or insoluble drugs in an appropriate vehicle e.g., suspensions.
- To provide sterile, clear, and particulate-free liquid dosage forms of substances e.g., injections and eye drops.
CAPSULE
A capsule is a gelatinous envelope enclosing the active substance. Capsules can be designed to remain intact for some hours after ingestion in order to delay absorption. They may also contain a mixture of slow and fast release particles to produce rapid and sustained absorption in the same dose. Capsules include medication that’s enclosed in an outer shell. This outer shell is broken down in the digestive tract and the medication is absorbed into the bloodstream and then distributed and metabolized in much the same way as medication from a tablet.
Types of Capsules:
Hard-shelled Capsules:
The outside of a hard-shelled capsule consists of two halves. One half fits inside the other to form a closed casing. The inside is filled with dry medication in powder or pellet form.
Other hard-shelled capsules contain medication in liquid form. These are known as liquid-filled hard capsules (LFHC).
Airtight LFHCs make it possible for a single pill to contain more than one drug. Hence, they’re ideal for dual-action or extended-release formulas.
- The powder or spheroids inside the capsule contains the active ingredient(s) and any excipients, such as binders, disintegrants, fillers, glidant, and preservatives.
- Tasteless and Odorless
- Easy in swallowing
- Formulating flexibility
- Uniquely suitable for blinded clinical trials
- Useful for extemporaneous compounding by Pharmacists
- Tend to be more expensive to produce than Tablets
- Not suitable for highly soluble salts
Soft-gel capsules have a slightly different appearance than hard-shelled capsules. They’re typically wider and are usually semi-transparent as opposed to opaque.
Also known as liquid gels, they contain medication suspended in gelatin or a similar substance. This substance is easily digested, at which point active ingredients are released and absorbed.
- Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.
- High accuracy/precision and hermetically sealed
- Reduce dustiness in the manufacturing process
- Reduce gastric irritancy
- Costly to produce
- Intimate contact between the cell and contents hence stability is a concern
- Mixed fills not adaptable
Manufacturing Materials:
As with hard gelatin capsules, soft gelatin capsules are predominantly administered orally. Some can be formulated and manufactured to produce a number of different drug delivery systems such as;
- Chewable Softgels where a highly-flavored shell is chewed to release the drug liquid fill matrix
- Suckable Softgels which consist of a gelatin shell containing the flavored medicament to be sucked and a liquid matrix (or just air inside the capsule)
- Twist-off Softgels which are designed with a tag to be twisted or snipped off, thereby allowing access to the fill material and
- Meltable Softgels designed for use as pessaries or suppositories.
- Gelatin capsules, informally called gel caps or gelcaps,are composed of gelatin manufactured from the collagen of animal skin or bone.
- Vegetable capsules are made up of cellulose, an important structural component in plants. To be more specific, the main ingredient of the vegetarian capsule is hydroxypropyl methylcellulose (HPMC). In the current market, the gelatin capsule is more broadly used than the vegetarian capsule because its cost of production is lower.
The process of encapsulation of hard gelatin capsules can be done on manual, semi-automatic and automatic capsule filling machines. Softgels are filled at the same time as they are produced and sealed on the rotary die of a fully automatic machine. Capsule fill weight is a critical attribute in encapsulation and various real times fill weight monitoring techniques such as near-infrared spectroscopy (NIR) and vibrational spectroscopy are used, as well as in-line weight checks, to ensure product quality.
The standard size of two shell Capsule:
| Size | Volume (ml) | Locked length (mm) | External diameter (mm) |
| 5 | 0.13 | 11.1 | 4.91 |
| 4 | 0.20 | 14.3 | 5.31 |
| 3 | 0.27 | 15.9 | 5.82 |
| 2 | 0.37 | 18 | 6.35 |
| 1 | 0.48 | 19.4 | 6.91 |
| 0 | 0.67 | 21.7 | 7.65 |
| 0E | 0.7 | 23.1 | 7.65 |
| 00 | 0.95 | 23.3 | 8.53 |
| 000 | 1.36 | 26.14 | 9.91 |
| 13 | 3.2 | 30 | 15.3 |
| 12 | 5 | 40.5 | 15.3 |
| 12el | 7.5 | 57 | 15.5 |
| 11 | 10 | 47.5 | 20.9 |
| 10 | 18 | 64 | 23.4 |
| 7 | 24 | 78 | 23.4 |
Volume is measured to the fill line, which is customary to the top of the smaller-diameter body half. After capping, some unused volume (air space) remains in the finished capsule.
Drug-embedded in empty capsule shell: A new class of capsules has been developed where drugs can be embedded in the capsule shell matrix. This allows different drugs to be delivered using the same capsule. The drug might be in a solubilized form, suspended from, or chemically bound form in the capsule shell matrix. The drug can be in the cap of the capsule, body of the capsule or in both body and cap of the capsule. One can embed more than one drug in the capsule shell matrix. The drug can be in the dissolved and suspended form in the capsule shell matrix. Thus, one can create various types of variations in these "drug-embedded capsules". The rate of release of the drug can vary based on the way drug is embedded in the capsule shell matrix and drug properties.
Capsule endoscopy is a procedure used to record internal images of the gastrointestinal tract for use in medical diagnosis. Newer developments are also able to take biopsies and release medication at specific locations of the entire gastrointestinal tract. The capsule (aka pill cam) is similar in shape to a standard pharmaceutical capsule, although a little larger, and contains a tiny camera and an array of LEDs powered by a battery. After a patient swallows the capsule, it passes along the gastrointestinal tract taking a number of images per second which are transmitted wirelessly to an array of receivers connected to a portable recording device carried by the patient. The primary use of capsule endoscopy is to examine areas of the small intestine that cannot be seen by other types of endoscopy such as colonoscopy or esophagogastroduodenoscopy (EGD).
Medical Uses:
Esophagogastroduodenoscopy (EGD), employs a camera attached to a long flexible tube to view the upper portion of the gastrointestinal tract, namely the esophagus, the stomach and the beginning of the first part of the small intestine called the duodenum, and a colonoscopy, inserted through the rectum, can view the colon and the distal portion of the small intestine, the terminal ileum, however, these two types of endoscopy cannot visualize the majority of the middle portion of the small intestine. Capsule endoscopy is used to examine parts of the gastrointestinal tract that cannot be seen with other types of endoscopy. It is useful when the disease is suspected in the small intestine, and can sometimes be used to find the site of gastrointestinal bleeding or the cause of unexplained abdominal pain, such as Crohn's disease. However, unlike EGD or colonoscopy, it cannot be used to treat pathology that may be discovered. Common reasons for using capsule endoscopy include diagnosis of unexplained bleeding, iron deficiency, or abdominal pain, searching for polyps, ulcers, and tumors of the small intestine, and diagnosis of inflammatory bowel disease. The images collected by the miniature camera during a session are transferred wirelessly to an external receiver worn by the patient, using any one of a band of appropriate frequencies. The collected images are then transferred to a computer for display, review, and diagnosis. A transmitted radio-frequency signal can be used to accurately estimate the location of the capsule and to track it in real-time inside the body and gastrointestinal tract. It is unclear if capsule endoscopy can replace gastroscopy for those with cirrhosis.
Side Effects:
Capsule endoscopy is considered to be a very safe method to determine an unknown cause of a gastrointestinal bleed. The capsule is usually excreted with the feces within 24–48 hours. There has been a report of retention of the capsule for almost four and a half years although the patient was asymptomatic. However, the risk of bowel obstruction may be countered by an abdominal X-ray to locate the device for removal by endoscopy or surgery.
Capsules remain popular as dosage forms, due to the various advantages afforded both to the manufacturer and to the patient. Capsules can be designed to remain intact for some hours after ingestion in order to delay absorption. They may also contain a mixture of slow and fast release particles to produce rapid and sustained absorption in the same dose.
Career Scope & Job Opportunities in the Pharmacy field are huge. Due to the opening of large pharmaceutical companies, the future in the field of pharmacy is bright.
Numerous jobs are available for pharmacists in government as well as private organizations. After completing your studies, you can easily find jobs in pharmaceutical industries, government departments, colleges and universities, hospitals, investigation and research institutes, etc.
Pharmacists can practice in community pharmacies, hospitals, clinics, extended care facilities, psychiatric hospitals, and regulatory agencies. The sales & Marketing job sector also hires the maximum number of pharmacy graduates.
One can also work in retail stores of medicines. After registering with the state Pharmacy Council, you can open chemist/drug shop and sell medicines as per Doctor’s prescription.
Pharmacists play a vital role in improving patient care through the medicine and information they provide. In addition, the pharmacy has excellent earning potential and is consistently ranked as one of the most highly trusted professions due to the care and service pharmacists provide.
About The Author:
Mr. Satyam Khare
Asst. Prof.
Corporate Institute of Pharmacy, Bhopal
satyamkhare88@gmail.com
+91 8878414505
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