The oral administration of some drugs in solid dosage form (e.g. tablets) can be difficult because some active ingredients can be oily or poorly soluble in water.
Soft gel technology allows a liquid or gel matrix to be incorporated into a soft gelatin capsule, improving the administration of the drug and the patient clearance.
Soft gelatin capsules (soft gel) were developed in the 1930s to mask the unpleasant taste and odor of drug substances. Since then, many improvements have been made in the production of these soft capsules.
It is estimated that more than 40% of API have poor biopharmaceutical properties, such as low aqueous solubility and/or permeability. These properties pose significant challenges for the oral absorption of the compounds and for the development of orally bioavailable dosage forms.
The development of the soft gel dosage form is a breakthrough in the oral delivery of compounds that are difficult to dissolve in water. The soft gel dosage form offers several advantages over other oral dosage forms, such as delivering a liquid matrix designed to solubilize and improve the oral bioavailability of poorly-soluble compounds, delivering low and ultra-low doses of a compound.
IBSA has the technological know-how to develop and manufacture transdermic patches - topical patches that are based on both hydrogel and drug-in-adhesive technology - in its own manufacturing plants. This know-how renders IBSA unique in the European pharmaceutical landscape as it is one of the few companies in the world that can offer both of these technologies.
Transdermic patches control the release of a drug for periods of time varying from 24 hours to one week, offering several advantages over oral administration, such as ensuring that the drug is taken, the maintenance of optimal concentrations of the drug in the bloodstream, and a reduction in the frequency of administration. A further advantage is the bypassing of the hepatic first pass effect compared to oral consumption, which increases bioavailability and reduces side effects. Transdermic patches can be applied without the assistance of a doctor or nurse, making them easier to use for the patient, and in the case of patients who have trouble taking drugs orally, administration of the drug is certain. The transdermic patch is normally composed of an adhesive matrix, made of polyacrylate, silicone or other adhesive, containing the active ingredient, plus a support and protective layer that is removed prior to application. The structure of the patch can also be more complex, for example, including multiple layers of adhesive containing different concentrations of the active ingredient or membranes that control its release.
Patches for topical use are based on the same principles of transdermic patches, with the only difference that the drug has an effect only around the area where the patch is applied. The patch offers a number of advantages over other locally-applied products, such as creams, oils and gels. Its application is not messy, the dosage is accurate, and the drug does not come into contact with clothing and thus avoids stains. The patch is applied every 12 to 24 hours. The patches range from anti-inflammatory patches to dermatological patches. IBSA’s extensive know-how and production capacity make it one of the largest manufacturers of patches for topical use.
The company has innovated these technologies, registering many patents and counting major realities in the sector among its customers.
The oral route of drug administration is the preferred route due to its ease of administration, non-invasiveness, adaptability, patient compliance and acceptability. Among the various dosage forms, the use of polymeric films for delivering medication into the buccal cavity has developed great potential in recent times. Orally disintegrating films (ODFs), when placed on the tongue, immediately hydrate by soaking up saliva following disintegration and/or dissolution, releasing an active pharmaceutical agent from the dosage form. These systems were developed as an alternative to more conventional dosage forms, such as, for instance, fast disintegrating tablets and capsules for geriatrics and pediatric patients having difficulty in swallowing conventional dosage forms. A typical ODF is usually equal to the size of a postage stamp.
The administration of ODFs has numerous advantages, such as, for example:
- easy transportation;
- ease of swallowing for geriatrics and pediatrics;
- convenient and accurate dosing;
- no need for water for administration, for patients that suffer from nausea;
- convenient for dysphasic patients having difficulty in swallowing tablets and capsules;
- potential rapid onset of action with increased bioavailability due to bypassing hepatic first pass effect and stability.
A thin film dissolves more rapidly than other conventional dosage forms. Furthermore, thin films are less friable and have a dosage form that is easy to carry compared to commercialized tablets that disintegrate quickly in the mouth and need special packing. Likewise, a single dose of strip can be carried individually without requiring a secondary container. Thin film does not have the poor stability of liquid dosage forms, especially that of aqueous formulations. Unlike thin films, liquid dosage forms require great care to be taken to ensure that the amount is measured accurately and the bottle to be shaken every time before administration: this may contribute to less acceptance by patients.
Furthermore, film that dissolves orally is very useful for pediatric, geriatric, and psychiatric patients, since it is easy to administer and avoids the risk of choking or suffocation, thus ensuring patient safety. Moreover, the polymeric thin films can also be beneficial for bedridden and non-cooperative patients as they can be administered easily and are hard to spit out. A thin film is useful in cases where action needs to be taken quickly, such as in motion sickness, sudden episodes of allergic attacks or coughing, bronchitis or asthma.
Many of the well-known state-of-the-art films use expensive polymers, such as pullulan, and hydrocolloid, and natural gums, as the film-forming component.
The formulation and the manufacturing process of IBSA ODFs are based on two patents (EP2900215 and EP1689374) that can solve this problem, replacing pullulan with less expensive ingredients that are, in any case, capable of maintaining the required properties, like their quick dissolution times, mouth freshness, marked aroma, and simplicity of preparation.
On the other hand, natural gums and hydrocolloids can be source of microbiological contamination that can be harmful for the patient and affect the stability of ODFs. Hydrocolloids are necessary in order to facilitate the disintegration of the film but they leave a clammy sensation in the mouth, since they tend to gel in contact with saliva.
The patented formulations of ODFs resolve these issues, providing film with improved physical resistance, that can be loaded with a relatively high amount of drug, maintaining the rapid disintegration time and a clean-mouth sensation.
NAHYCO® HYBRID TECHNOLOGY
Hyaluronic acid (HA) is a molecule that is distributed widely throughout the body in connective, epithelial, and neural tissues, the characteristics and benefits of which have been studied and used for a long time and are universally recognized. So, what can we add to everything that is already known about this impressive substance?
One of the challenges that was faced when using HA for cutaneous and intraarticular treatments is its half-life which ranges between a few hours and two or three days. In general, two main reasons for the breakdown of the HA chains are degradation by Hyaluronidases (enzymatic degradation) and by acting as a free radical scavenger (chemical depolymerization). In order to increase the duration of various treatments, chemical-based stabilization procedures are used to change the structure of the molecules.
IBSA took on this challenge and developed an innovative and unique production technology known as NAHYCO® HYBRID TECHNOLOGY.
NAHYCO® Hybrid Technology generates a new method of intervention to thermally stabilize high molecular weight (H-HA) with low molecular weight (L-HA) hyaluronic acid. Through this patented process, strong hydrogen bonds are created between the L-HA and H-HA molecules resulting in hybrid cooperative complexes without the use of any chemical cross-linking agents. This technology not only increases the duration of HA, it allows us to offer the highest concentrations of HA without compromising manageability or safety.