CN118043038A - Film-forming composition comprising pectin - Google Patents

Abstract

The present specification relates to a film forming composition comprising High Ester (HE) pectin as a film forming polymer, water and optionally a plasticizer. The present specification further relates to capsules comprising a soft or hard capsule shell made from the film-forming composition.

Description

Film-forming composition comprising pectin

Technical Field

The present specification relates to a film-forming composition comprising pectin as film-forming polymer and the use of the film-forming composition for the preparation of capsules and coatings.

Background

Capsules are the second most common solid oral dosage form following traditional tablets. By 2014, the estimated market size of capsules was $ 20 billion and can be further subdivided into hard and soft capsules. Currently, the hard and soft capsule markets are based on gelatin, which is a hydrolyzed protein derived from collagen obtained by boiling animal bones and cartilage in water under pressure. However, due to consumer preference for health, dietary, or religious reasons, the use of gelatin is decreasing, while other materials continue to progress. Particularly in soft capsules such as carrageenan (e.g. obtainable from IFF) The plant material has been able to occupy about 13% of the soft capsule market, with an expected growth rate of 14%.

Carrageenan-based soft capsule systems have been marketed for many years, but consumers have been hesitant to use the product due to misunderstanding of the safety of carrageenan. There are some scientific reports and consumer groups reporting that wrongly attribute negative toxicological effects on animals to carrageenan, whereas the material actually tested is degraded carrageenan or degraded carrageenan (poligeenan). There is confusion between the scientific community and the public as to the use of carrageenans (molecular weight between 200 and 800 kDa) as food additives and the degraded forms of carrageenans such as d-CGN (molecular weight range 20-40 kDa) and PGN (MW range 10-20 kDa), see McKim JM,Willoughby JA Sr,Blakemore WR,Weiner ML：Clarifying the confusion between poligeenan,degraded carrageenan,and carrageenan：A review of the chemistry,nomenclature,and in vivo toxicology by the oral route[ clarify the confusion between degraded carrageenans, degraded carrageenans and carrageenans: reviews of chemical composition, nomenclature, and in vivo toxicology of oral route ]. Crit Rev Food Sci Nutr [ food science and nutritional reviews ].2018, month 6, 14:1-20; james m. mckim, jamin a. Willoughby Sr., william r. Blakeore and Myra L.Weiner："Clarifying the confusion between poligeenan,degraded carrageenan,and carrageenan：A review of the chemistry,nomenclature,and in vivo toxicology by the oral route[ clarify the confusion between degraded carrageenan, degraded carrageenan and carrageenan: an overview of chemical composition, nomenclature, and in vivo toxicology of the oral route, [ Crit Rev Food Sci Nutr [ food science and nutritional reviews ].2019, volume 59, 19 th phase, 3054-3073; myra l.weiner, james m.mckim, jr.: the carrageenan disputes were reviewed for S.David, C.S.Levi, L.Fahoum, Y.Ungar, E.G.Meyron-Holtz, a. Shpipelman and u.lesmes ", food function [ Food and function ],2018,9, 1344-1352] "Revisiting the carrageenan controversy：do we really understand the digestive fate and safety of carrageenan in our foods?[: is we really aware of the digestive fate and safety of carrageenan in our food? Comment ;James M.McKim Jr.,Heidi Baas,Gabriel P.Rice,Jamin A.Willoughby Sr.,Myra L.Weiner,William Blakemore：Effects of carrageenan on cell permeability,cytotoxicity,and cytokine gene expression in human intestinal and hepatic cell lines[ effects of carrageenan on cell permeability, cytotoxicity and cytokine gene expression in human intestinal and hepatic cell lines Food AND CHEMICAL Toxicology [ Food and chemical Toxicology ], volume 96, month 10, pages 1-10, ;Myra L.Weiner：Parameters and pitfalls to consider in the conduct of food additive research,Carrageenan as a case study[ parameters and defects to be considered in Food additive studies, exemplified by carrageenan, food AND CHEMICAL Toxicology [ Food and chemical Toxicology ], volume 87, month 1, pages 31-44, ;Myra L.Weiner,James M.McKim,William R.Blakemore：Addendum to Weiner,M.L.(2016)Parameters and Pitfalls to Consider in the Conduct of Food Additive Research,Carrageenan as a Case Study[Weiner,M.L.(2016) parameters and defects to be considered in Food additive studies, exemplified by carrageenan, appendix of research, food AND CHEMICAL Toxicology [ Food and chemical Toxicology ], volume 107, part a, month 9, pages 2017, pages 208-214.

Because of the significant problems associated with using carrageenan in capsule systems, there is a need in the art to identify alternative non-gelatin materials having properties that make them suitable for capsule materials. An alternative plant material that may be included in the film-forming composition is pectin, which has been disclosed in the art as a film-forming polymer for the preparation of hard or soft capsules, see e.g. WO 02/17886. The pectin disclosed for this purpose is a Low Ester (LE) pectin which imparts enteric properties to the capsule such that the capsule is insoluble under gastric conditions (pH 1.2) and readily soluble under intestinal conditions (pH 6.8). In the composition of WO 02/17886 pectin is typically combined with a setting system. At least one other film-forming polymer is needed to improve the mechanical properties of the capsules.

Disclosure of Invention

It is an object of the present specification to provide suitable non-animal (gelatin-free) alternatives to carrageenan in soft and hard capsules, intended to allow immediate release of the active ingredient contained in the capsules. Several candidate materials were tested based on physical characteristics such as film forming ability, temperature processing window, material source and material cost. A good candidate found as a film-forming polymer providing immediate release of the active ingredient in a capsule or tablet is High Ester (HE) pectin.

Accordingly, the present specification relates to a film forming composition comprising High Ester (HE) pectin as a film forming agent, water and optionally a plasticizer.

In another aspect, the present description relates to a capsule comprising a capsule shell prepared from the film-forming composition and a fill material.

In a further aspect, the present description relates to the use of the film forming composition for providing a coating on a solid dosage form.

Drawings

Fig. 1 is a graph showing puncture strength of films made from HE pectin with or without buffer and with or without HP starch and with different amounts of glycerol as plasticizer compared to films containing carrageenan.

Fig. 2 is a graph showing the elasticity of films made from HE pectin with or without buffer and with or without HP starch and with different amounts of glycerol as plasticizer compared to films containing carrageenan.

Fig. 3 is a graph showing hardness, burst strength, and burst distance of the capsule prepared in example 3 compared to a capsule containing carrageenan.

Fig. 4 is a graph showing the release of theophylline from uncoated tablets and tablets coated with a film-forming composition comprising 3% he pectin.

Detailed Description

Pectin is a structural polysaccharide typically found in the primary cell walls and intercellular layers of green terrestrial plants (e.g., fruits and vegetables) in the form of a water-insoluble parent pectic substance (protopectin). The main sources of commercial pectin products are citrus peel and apple pomace, where the protopectin comprises 10% -40% by weight of the dry matter.

Pectin is a generic name for water-soluble compounds produced from limited hydrolysis of protopectin. The exact nature of the protopectin is not fully understood. However, it is generally recognized that protopectins are complex structures in which pectin is attached to other cell wall components such as cellulose, cell wall proteins, and hemicellulose by covalent bonds, hydrogen bonds, and/or ionic interactions.

Pectin comprises a linear polygalacturonic acid chain (- (1-4) -linked-D-galacturonic acid polymer) with an inserted rhamnogalacturonan backbone (repeating disaccharide α - (1-4) -D-galacturonic acid- α - (1-2) -L-rhamnose polymer), which often has side chains of polymeric arabinogalactan glycosides linked to the O-3 or O-4 positions of the L-rhamnose. Galacturonic acid sequences can have D-xylose and D-apioside attached to their O-2 or O-3 positions, which can also be substituted by an ester-linked acetyl group. The long chain of α - (1-4) -linked D-galacturonic acid residues is often referred to as the "smooth region" whereas the highly branched rhamnogalacturonan region is often referred to as the "hairy region".

Pectin molecules have a molecular weight up to over 200,000da and a degree of polymerization up to over 1000 units. A proportion of the carboxylic acid groups of the galacturonic acid units are methyl-esterified. In plants, the residual carboxyl groups are partially or completely neutralized by cations of calcium, potassium and magnesium inherently contained in plant tissues.

"Degree of esterification" (DE) means the extent to which the free carboxylic acid groups contained in the galacturonic acid units of pectin have been methyl esterified. If more than 50% of the carboxyl groups are esterified, the resulting pectin is referred to as "high ester pectin" (abbreviated "HE pectin"). If less than 50% of the carboxyl groups are esterified, the resulting pectin is referred to as a "low ester pectin" (LE pectin for short), or "low methoxy pectin". Pectin is also available in amidated form, wherein 8% -25% of the carboxyl groups are replaced by amide groups.

The structure of pectin, in particular the degree of esterification, determines its physical and/or chemical properties. For example, pectin gelation depends on the chemical nature of the pectin, in particular the degree of esterification and the degree of polymerization. However, in addition, pectin gelation depends on pectin concentration and environmental conditions like soluble solids content, pH and calcium ion concentration.

In the film-forming compositions of the present description, advantageous results are obtained in terms of film-forming properties and immediate release when the HE pectin exhibits a degree of esterification higher than 52%, such as higher than 54%, such as higher than 56% or higher than 58%, such as about 60%. In the context of the present invention, "immediate release" is intended to indicate that the active ingredient/substance is released within 15 minutes after immersion in simulated gastric fluid at pH 1.2. It is generally preferred that HE pectin exhibits a degree of amidation of 0%, but if a delayed release profile is desired for the final film, a small amount of amidated pectin may be added to the composition. The compositions of the present specification may advantageously comprise HE pectin in an amount of 10% -35% by weight of the composition.

In one embodiment, the film-forming composition of the present description may further comprise a second film-forming agent to mitigate brittleness of films made of HE pectin alone, which brittleness may result in the composition not filling the mold cavity during rotary mold encapsulation and thus in capsule underfilling. Examples of suitable second film formers are starch, starch hydrolysates, starch derivatives, beta-1, 3-glucan, cellulose gums, hydrocolloids such as xanthan gum, alginates, carrageenan or alkyl cellulose ethers such as methyl cellulose or hydroxypropyl methyl cellulose. The second film former may contribute to the beneficial film forming properties of the composition, such as increased puncture strength and elasticity.

In preferred embodiments, the compositions of the present description may comprise native starch or chemically modified starch as the second film forming agent. In the context of the present invention, "native starch" is intended to mean starch which has not been subjected to chemical modification and/or has been processed only minimally. "chemically modified starch" is intended to mean starch derivatives which have undergone chemical substitution such as hydroxypropylation, carboxymethylation or other etherification steps. The starch may be selected from the group consisting of corn starch, rice starch, potato starch, pea starch, tapioca starch, wheat starch, rye starch, oat starch, barley starch or starch derived from beans and mixtures thereof. It is generally preferred that the starch contains less than 100% amylopectin, i.e. it is not a waxy starch. The chemically modified starches currently favored may be, for example, hydroxypropylated starches or hydroxyethylated starches, preferably hydroxypropylated starches.

In another embodiment, the film-forming composition of the present invention may contain a plasticizer in order to reduce brittleness and increase flexibility of films made of HE alone. In this embodiment, the plasticizer may be selected from the group consisting of glycerin, sorbitol, lactitol, maltitol, polydextrose, polyethylene glycol, or mixtures thereof.

In one embodiment, the film-forming composition of the present description further comprises a divalent cation salt. Such salts have been found to facilitate the setting of HE pectin when the film-forming composition is used to prepare capsules by impregnation. In particular, it has been found that divalent cation salts are effective when they are poorly water soluble calcium salts such as CaCO ₃.

In further embodiments, the film-forming composition further comprises one or more buffers, which may be selected from the group consisting of sodium citrate, potassium sodium tartrate, and sodium tripolyphosphate, for example.

In further embodiments, the present description relates to a capsule comprising a capsule shell prepared from the film-forming composition of the present description and a fill material. The fill material within the capsule shell may typically comprise a pharmaceutically active ingredient, dietary supplement, cosmetic, flavoring, foodstuff, agrochemical or fragrance.

In one embodiment, the capsule may comprise a hard capsule shell. Hard capsule shells are typically manufactured using an dip molding process. In this process, a pin mold is immersed in the film-forming composition. A film is formed by gelling the film-forming polymer on the pins, followed by drying the film on the pins to obtain the capsule shell. The shell is then stripped from the pin and cut to the desired length. Thus, a capsule cap and a capsule body are obtained, which can subsequently be filled with a substance and joined, thus obtaining a filled capsule. When using this type of dip molding process, it must be ensured that the impregnating composition adheres to the pin surface and rapidly gels once the pin is removed from the dip bath. This prevents the composition from flowing on the surface of the pin, thereby achieving the shell or film thickness distribution required to make the capsule.

In alternative embodiments, the capsule may comprise a soft capsule shell. The soft capsule shells may typically be prepared by a rotary die process, in which two film strips are each cast onto a rotating drum, passed under heated wedges, and then subsequently pressed between two dies having cavities of the desired size/shape. As The capsule is pressed into The mold cavity, the capsule is filled by The wedge, essentially as described in US 6340473 B1, WO 98/42294 and The Theory AND PRACTICE of Industrial Pharmacy [ Theory and practice of industrial pharmacy ], labman, lieberman and Kanig, editions 3 rd.

In particular, when preparing soft capsules, the fill material may be a liquid or semi-solid material comprising a pharmaceutically active ingredient, a dietary supplement, a cosmetic, a flavoring, a foodstuff, an agrochemical or a fragrance.

Both the hard and soft capsules of the present description provide for immediate release of the active ingredient in the fill material.

The capsule shell may further comprise optional additives such as colorants, flavor and taste modifiers, antioxidants, plasticizers, compatibilizers and surfactants. For example, when producing capsules, water-soluble food dyes, such as oxidized red, or natural dyes, may be used as colorants; tiO ₂ can be used as opacifying agent.

In a further aspect of the present description, the film-forming compositions of the present invention may be used to coat dosage forms (e.g., tablets, granules, pills, caplets, troches, suppositories, pessaries, or implantable dosage forms) to form a coated composition that provides immediate release of the active ingredient contained in the dosage form. Preferred dosage forms are pharmaceutical, nutritional supplements or agricultural dosage forms.

Useful additives for the coating in solid form are plasticizers, solid loading enhancers, second film forming polymers, surfactants, lubricants, polishing agents, pigments, anti-tackifiers, glidants, opacifiers, colorants, and any combination thereof.

Numbered examples of this specification:

1. A film-forming composition comprising High Ester (HE) pectin as a film-forming polymer, water and optionally a plasticizer.

2. The composition of embodiment 1, wherein the HE pectin exhibits a degree of esterification of greater than 52%, such as greater than 54%, such as greater than 56%, or greater than 58%, such as about 60%, such as in the range of 52% -60%, such as in the range of 54% -60%, such as in the range of 56% -60%, such as in the range of 58% -60%.

3. The composition of examples 1 or 2, wherein the HE pectin exhibits a degree of amidation of 0%.

4. The composition of any one of embodiments 1-3, comprising HE pectin in an amount of 10% -35% by weight of the composition.

5. The composition of any of embodiments 1-4, further comprising one or more buffering agents, for example, selected from the group consisting of sodium citrate, potassium sodium tartrate, and sodium tripolyphosphate.

6. The composition of any of embodiments 1-5, further comprising a second film-forming polymer selected from the group consisting of native or chemically modified starch, xanthan gum, sodium alginate, beta-1, 3-glucan, and carrageenan.

7. The composition of embodiment 6 wherein the starch is selected from the group consisting of corn starch, rice starch, potato starch, pea starch, tapioca starch, wheat starch, rye starch, oat starch, barley starch, and starches from legumes, and mixtures thereof.

8. The composition of examples 6 or 7 wherein the starch contains less than 100% amylopectin.

9. The composition of embodiment 6 or 7, wherein the starch is hydroxypropylated starch or hydroxyethylated starch, preferably hydroxypropylated starch.

10. The composition of any of embodiments 1-9 wherein the plasticizer is selected from the group consisting of glycerin, sorbitol, maltitol, polydextrose, polyethylene glycol, or mixtures thereof.

11. The composition of any of embodiments 1-10, further comprising a divalent cation salt.

12. The composition of embodiment 11, wherein the divalent cation salt is a poorly water-soluble calcium salt, such as CaCO ₃.

13. A capsule comprising a capsule shell prepared from the film-forming composition of any one of claims 1-12, and a fill material.

14. The capsule of embodiment 13 comprising a soft capsule shell.

15. The capsule of embodiment 13 comprising a hard capsule shell.

16. The capsule of any of embodiments 13-15, wherein the fill material comprises a pharmaceutically active ingredient, a dietary supplement, a flavoring, a foodstuff, an agrochemical or a fragrance.

17. The capsule of embodiment 13, wherein the fill material is a liquid, semi-solid, or solid material.

18. The capsule of any one of embodiments 13-17 for immediate release of a pharmaceutically active ingredient, dietary supplement, flavoring, foodstuff, agrochemical or fragrance contained in the fill material.

19. Use of the film-forming composition of any of embodiments 1-12 for providing a coating on a solid dosage form.

20. The use of embodiment 19, wherein the coating is an immediate release coating.

Examples

Example 1

Films made from compositions comprising HE pectin as the sole film-forming polymer

The film-forming composition was prepared from the following ingredients.

Composition of the components	Example 1a	Example 1b	Example 1c
				HE pectin	35％	20％	20％
Glycerol	25％	30％	40％
				Water and its preparation method	40％	50％	40％

Gel materials were prepared in PREMIERE MILL (relaxation-resistant (Netzsch)) bench mixer equipped with two anchor blades. Water and glycerin were weighed and loaded into jacketed mixing bowls. The bowl is then heated via an external temperature bath while the solid components are weighed. HE pectin was weighed into a 1 gallon zipper bag (Ziploc bag) and homogenized by hand to ensure no clumping. Once the liquid ingredients reached 50-55 ℃, HE pectin was loaded into the mixing bowl. The gel was mixed for at least 2 hours and the internal temperature was brought to 90 ℃ to 95 ℃. The visual appearance and film forming ability of the gel substance prepared were evaluated.

Wet film puncture strength and elasticity were measured using a ta.xt plus texture analyzer (available from stabilized microsystems, inc. (Stable Microsystems)). A6.35 mm circular probe traveling at 1mm/s penetrated the membrane and the maximum penetration force and penetration distance were recorded.

HE pectin films show good film quality in terms of clarity and feel. Fig. 1 shows the puncture strength of the resulting membrane. The puncture strength increases with the increase of pectin concentration, and the fruit film can be matched with the fruit filmThe puncture strength of the (k-2-carrageenan) is comparable. Example 1a blend with 35% he pectin showed the highest puncture strength, probably due to the higher polymer concentration.

Fig. 1 shows puncture strength. FIG. 2 shows the formation of a carrageenan-L-carrageenanThe elastic properties of the resulting film compared to films made with HE pectin and increasing levels of plasticizer. As can be seen from fig. 2, increasing the amount of plasticizer did not increase the elasticity of the HE fruit film.

Example 2

Films made with HE pectin and HP starch as the second film-forming polymer

The film-forming composition was prepared from the following ingredients.

To prepare the film composition of example 2c, 250g of glycerin and 400g of water were added to a PREMIERE MILL mixing device and heated with a circulating oil bath until they reached about 50-60 ℃. While mixing the liquid components, 200g HE pectin and 150g HP modified starch were weighed and placed in a sealable plastic bag until uniform. The solid components were then charged into a mixing bowl while stirring. The ingredients were mixed for 2 hours to reach a final temperature of about 93 ℃. The film was cast manually onto a polytetrafluoroethylene sheet using a 1.27mm doctor blade. The membranes were left overnight under ambient laboratory conditions to dry.

Additional gels were prepared with a blend of HE pectin and HE pectin containing buffer as shown in the above table. The blend samples showed improved mechanical properties, see fig. 1 and 2.

Comparative example a:

a gel was prepared as in example 2, but amidated pectin (24% esterified, 23% amidated) was used instead of HE pectin.

Comparative example B:

200g of glycerol and 400g of water were added to PREMIERE MILL mixing units and heated with a circulating oil bath until they reached 40 ℃. Then 400g 225bloom gelatin was added to the liquid ingredients and a vacuum was applied to the mixture. The ingredients were mixed for 2 hours to a final temperature of about 70 ℃.

Disintegration measurements were performed in pH 1.2, pH 6.8 and pH 12 buffer solutions using standard drug disintegration apparatus. Disintegration time was normalized by film thickness. 800mL of buffer solution was added to a glass beaker and equilibrated to 37℃in a water bath. Dry film samples sandwiched between two plastic tubes were loaded on a standard drug disintegration carousel, with both sides of the film open to the environment. A stainless steel ball bearing was placed on top of each membrane to serve as a visual indicator of when the membrane was dissolved. The disintegration time was measured with a stopwatch and then normalized by the film thickness. If the film was not dissolved within 1 hour, the test was stopped and recorded as 60 minutes, but the film was recorded undissolved. The disintegration time was then multiplied by 0.74mm to calculate the disintegration time for a normal capsule thickness.

* DND = undissolved

Comparative example C:

A gel was prepared as in example 2, but low ester pectin (37% esterified, 0% amidated) was used instead of HE pectin.

Example 3

Preparation of Soft capsules comprising HE pectin and modified corn starch as film Forming Polymer

A film-forming composition containing 20% he pectin, 15% modified corn starch, 25% glycerol and 40% water was prepared in a4 gallon Ross CDA4 mixer under the same conditions described in example 2. The transfer line was preheated to 78 ℃ and the spreader box was preheated to 82 ℃. The drum and mold were cooled throughout the run to maintain 20 ℃. The film thickness was adjusted to 0.74mm and fed through FARMATECK FTK packaging machine. The wedge is then placed over the mold and film and heated until the capsule is sealed at about 55 ℃. Capsules were made using a 7.5 oval mold with light mineral oil filled at 400 mg. The wet capsules were then placed on trays and placed in a low humidity room at 20 ℃ and 5% -15% r.h. for 2 hours, then transferred to a drying oven at 40 ℃ and placed overnight. The dried capsules were then removed from the oven for cooling and then stored in sealed plastic bags until ready for testing.

The physical properties of the capsules were tested using a ta.xt plus texture tester equipped with a 2mm probe running at 0.5mm/sec (burst force) or a 38mm probe running at 5mm/sec (burst strength). The capsules were tested with the seam parallel to the probe and the peak force that ruptured the capsule or burst the capsule at the seam was recorded.

The results are shown in fig. 3, from which it can be seen that the capsules according to example 3 show a hardness (measured as the force required to rupture the capsule) comparable to that of the capsules containing carrageenan, while the burst strength and elasticity (burst distance) are slightly lower. However, the burst strength and elasticity measured for the capsules of the present specification are considered sufficient to make them a commercially viable option.

All capsules were dissolved in pH 1.2 medium within 7.6min (average of 5 capsules). In a pH 6.8 medium, the capsules dissolved within 8.7min (average of 4 capsules), which meets the immediate release requirement of less than 15 min.

Example 4

Preparation of hard capsules comprising HE pectin as film-forming polymer

Hard capsules were prepared using a five pin infusion system. An impregnating solution was prepared by adding 20g HE pectin to 80g DI water preheated to 50 ℃. The HE pectin solution was then stirred with an overhead stirrer equipped with propeller blades for 2 hours. The warmed solution was then transferred to a pre-warmed aluminum tank for capsule infusion. The cold pins were immersed in the warm solution and held for 10 seconds. After the pins were removed from the solution, the pins were shaken 50 times to evenly distribute the solution. Once the shaking is completed, the pin is stationary in the upright position and the capsule is dried in situ for 16 hours before removal.

Example 5

Film coated tablets

Coated tablets were prepared using Vector laboratory development coating systems. A 5% pectin aqueous solution was prepared by adding high ester pectin and FD & C red 40 dye to preheated DI water. The solution was then mixed via an overhead stirrer for 2 hours and stored until needed. 550g of pre-prepared 800mg theophylline tablets were placed in a pan coater rotating at 20 rpm. The pectin solution was sprayed at 2.5g/min using an inlet air temperature of about 65 ℃. Tablets were coated at 3% weight gain and then subjected to a drug dissolution test to evaluate the effectiveness of the coating. The results are shown in fig. 4, from which it can be seen that the release of theophylline from the coated tablets is very similar to the release from the uncoated tablets, i.e. HE pectin coating provides immediate release of the active ingredient.

Claims (15)

1. A film-forming composition comprising High Ester (HE) pectin as a film-forming polymer, water and optionally a plasticizer.

2. The composition of claim 1, wherein the HE pectin exhibits a degree of esterification of greater than 52%, such as greater than 54%, such as greater than 56%, or greater than 58%, such as about 60%, such as in the range of 52% -60%, such as in the range of 54% -60%, such as in the range of 56%,60%, such as in the range of 58% -60%.

3. The composition of claim 1 or 2, wherein the HE pectin exhibits a degree of amidation of 0%.

4. A composition according to any one of claims 1 to 3 comprising HE pectin in an amount of 10% -35% by weight of the composition.

5. The composition of any one of claims 1-4, further comprising one or more buffers, for example selected from the group consisting of sodium citrate, potassium sodium tartrate and sodium tripolyphosphate.

6. The composition of any one of claims 1-5, further comprising a second film-forming polymer selected from the group consisting of native or chemically modified starch, xanthan gum, sodium alginate, beta, 1, 3-glucan, and carrageenan, such as starch selected from the group consisting of corn starch, rice starch, potato starch, pea starch, tapioca starch, wheat starch, rye starch, oat starch, barley starch, and starches from legumes, and mixtures thereof.

7. The composition of claim 6, wherein the starch contains less than 100% amylopectin.

8. Composition according to claim 6 or 7, wherein the starch is hydroxypropylated starch or hydroxyethylated starch, preferably hydroxypropylated starch.

9. The composition of any of claims 1-8, wherein the plasticizer is selected from the group consisting of glycerin, sorbitol, maltitol, polydextrose, polyethylene glycol, or mixtures thereof.

10. The composition of any one of claims 1-9, further comprising a divalent cation salt, such as a poorly water soluble calcium salt, such as CaCO ₃.

11. A capsule comprising a capsule shell, such as a soft or hard capsule shell, prepared from the film-forming composition of any one of claims 1-10, and a fill material.

12. The capsule of claim 11, wherein the fill material comprises a pharmaceutically active ingredient, a dietary supplement, a flavoring, a foodstuff, an agrochemical or a fragrance.

13. Capsule according to any of claims 11-12, wherein the filling material is a liquid, semi-solid or solid material.

14. The capsule of any one of claims 11-13 for immediate release of a pharmaceutically active ingredient, dietary supplement, flavor, foodstuff, agrochemical or fragrance contained in the fill material.

15. Use of a film forming composition according to any of claims 1-10 for providing a coating, such as an immediate release coating, on a solid dosage form.